A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer (PERUSE)

August 31, 2020 updated by: Hoffmann-La Roche

A Multicenter, Open-Label, Single-Arm Study of Pertuzumab in Combination With Trastuzumab and a Taxane in First Line Treatment of Patients With HER2-Positive Advanced (Metastatic or Locally Recurrent) Breast Cancer

This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.

Study Overview

Status

Completed

Conditions

Breast Neoplasms

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1436

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Algeria
- - Algiers, Algeria, 16000
    - CPMC; Service d'Oncologie Médicale
Argentina
- - La Rioja, Argentina, F5300COE
    - Centro Oncologico Riojano Integral (CORI)
  - Rosario, Argentina, S2000KZE
    - Instituto de Oncología de Rosario
Australia
- Australian Capital Territory
  - Canberra, Australian Capital Territory, Australia, 2606
    - Canberra Hospital; Medical Oncology
- New South Wales
  - Camperdown, New South Wales, Australia, 2050
    - Royal Prince Alfred Hospital; Medical Oncology
- Queensland
  - Chermside, Queensland, Australia, 4032
    - HOCA Chermside
  - South Brisbane, Queensland, Australia, 4101
    - Mater Hospital; Cancer Services
- Victoria
  - Melbourne, Victoria, Australia, 3084
    - Austin and Repatriation Medical Centre; Cancer Services
  - Parkville, Victoria, Australia, 3052
    - Royal Melbourne Hospital; Hematology and Medical Oncology
Austria
- - Graz, Austria, 8036
    - Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie
  - Graz, Austria, 8036
    - LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
  - Innsbruck, Austria, 6020
    - Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
  - Linz, Austria, 4010
    - Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1
  - Salzburg, Austria, 5020
    - Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
  - Steyr, Austria, 4400
    - A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie
  - Wien, Austria, 1090
    - Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie
  - Wien, Austria, 1090
    - Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
Belgium
- - Brussel, Belgium, 1090
    - UZ Brussel
  - Edegem, Belgium, 2650
    - UZ Antwerpen
  - Gent, Belgium, 9000
    - UZ Gent
  - Leuven, Belgium, 3000
    - UZ Leuven Gasthuisberg
  - Liège, Belgium, 4000
    - CHU Sart-Tilman
Brazil
- RJ
  - Rio de Janeiro, RJ, Brazil, 22271-110
    - Oncologistas Associados
- RS
  - Porto Alegre, RS, Brazil, 90610-000
    - Hospital Sao Lucas - PUCRS
- SP
  - Jau, SP, Brazil, 17210-120
    - Hospital Amaral Carvalho
  - Sao Paulo, SP, Brazil, 01308-050
    - Hospital Sirio Libanes; Centro de Oncologia
  - Sao Paulo, SP, Brazil, 01317-000
    - Hospital Perola Byington
  - Sao Paulo, SP, Brazil, 05403-000
    - Hospital das Clinicas - FMUSP
  - São Paulo, SP, Brazil, CEP 01321-001
    - Hospital Sao Jose
Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Cross Cancer Institute ; Dept of Medical Oncology
- British Columbia
  - North Vancouver, British Columbia, Canada, V7L 2L7
    - Lions Gate Hospital
  - Victoria, British Columbia, Canada, V8R 6V5
    - Bcca - Vancouver Island Cancer Centre; Oncology
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 2Y9
    - Queen Elizabeth II Health Sciences Centre; Oncology
- Ontario
  - Brampton, Ontario, Canada, L6R 3J7
    - William Osler Health System Brampton Civic Hospital
  - Kitchener, Ontario, Canada, N2G 1G3
    - Grand River Hospital
  - Toronto, Ontario, Canada, M4N 3M5
    - Sunnybrook Odette Cancer Centre
- Quebec
  - Greenfield Park, Quebec, Canada, J4V 2H1
    - CSSS champlain - Charles-Le Moyne
  - Montreal, Quebec, Canada, H3T 1E2
    - McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
  - Montreal, Quebec, Canada, H2X 0C2
    - Centre Hospitalier de l'Université de Montréal (CHUM)
China
- - Beijing, China, 100142
    - Beijing Cancer hospital
  - Chongqing, China, 400038
    - Southwest Hospital , Third Military Medical University
  - Guangzhou, China, 510060
    - Sun Yet-sen University Cancer Center
  - Harbin, China, 150040
    - Heilongjiang Provincial Tumor Hospital
  - Nanjing, China, 210009
    - Jiangsu Cancer Hospital
  - Shanghai, China, 200120
    - Fudan University Shanghai Cancer Center
  - Tianjin, China, 300060
    - Tianjin Cancer Hospital
  - Xi'an, China, 710061
    - First Affiliated Hospital of Medical College of Xi'an Jiaotong University
  - Xi'an, China, 710032
    - The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
Ecuador
- - Portoviejo, Ecuador, EC130104
    - Hospital Solca Portoviejo; Oncologia
  - Quito, Ecuador, EC170124
    - Hospital Solca Quito; Oncologia
Egypt
- - Cairo, Egypt, 11555
    - Manial Specialized Hospital; Oncology
  - Cairo, Egypt, 11796
    - Nci; Oncology Dept
  - Cairo, Egypt, 11654
    - El Mokatam HIO Hospital
Estonia
- - Tallinn, Estonia, 13419
    - North Estonia Medical Centre Foundation; Oncology Center
  - Tartu, Estonia, 50406
    - Tartu University Hospital; Clinic of Hematology and Oncology
Finland
- - Helsinki, Finland, 00029
    - Helsinki University Central Hospital; Oncology Clinics
  - Pori, Finland, 28500
    - Satakunta Central Hospital; Oncology
  - Tampere, Finland, 33520
    - Tampere University Hospital; Dept of Oncology
  - Turku, Finland, 20520
    - Turku Uni Central Hospital; Oncology Clinics
France
- - Amiens, France, 80090
    - Clinique De L Europe; Radiotherapie Chimiotherapie
  - Angers, France, 49055
    - ICO Paul Papin; Oncologie Medicale.
  - Bordeaux, France, 33077
    - Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
  - Bourg En Bresse, France, 01012
    - Centre Hospitalier Fleyriat; Oncologie/Hematologie
  - Dechy, France, 59187
    - Centre Leonard De Vinci;Chimiotherapie
  - Dijon, France, 21079
    - Centre Georges Francois Leclerc; Oncologie 3
  - Dijon, France, 21000
    - Fondation Clement Drevon; Oncology
  - Hyeres, France, 83400
    - Clinique Sainte Marguerite; Oncologie Medicale
  - La Chaussee St Victor, France, 41260
    - Polyclinique de Blois; Chimiotherapie Ambulatoire
  - LeMans, France, 72000
    - Clinique Victor Hugo
  - Lille, France, 59000
    - Polyclinique Du Bois; Centre Bourgogne
  - Limoges, France, 87039
    - Clinique Chenieux; Oncology
  - Lyon, France, 69373
    - Centre Leon Berard; Departement Oncologie Medicale
  - Marseille, France, 13273
    - Institut Paoli Calmettes; Oncologie Medicale
  - Mougins, France, 06250
    - Centre Azureen De Cancerologie; Cons externes
  - Paris, France, 75231
    - Institut Curie; Oncologie Medicale
  - Paris, France, 75014
    - Hopital Cochin; Unite Fonctionnelle D Oncologie
  - Paris, France, 75475
    - Hopital Saint Louis; Service Onco Thoracique
  - Paris, France, 75181
    - Hopital Hotel Dieu; Oncologie Medicale
  - Perpignan, France, 66000
    - Centre Catalan D' Oncologie
  - Reims, France, 51057
    - Polyclinique De Courlancy; Centre Radiotherapie Oncologie
  - Rennes, France, 35042
    - Centre Eugene Marquis; Unite Huguenin
  - Saint Cloud, France, 92210
    - Centre Rene Huguenin; ONCOLOGIE GENETIQUE
  - Saint Gregoire, France, 35768
    - Chp Saint Gregoire; Cancerologie Radiotherapie
  - Saint Herblain, France, 44805
    - Ico Rene Gauducheau; Oncologie
  - Strasbourg, France, 67000
    - Institut D Oncologie Medical
  - Toulouse, France, 31059
    - Institut Claudius Regaud; Departement Oncologie Medicale
  - Valence, France, 26000
    - Hopital Prive Drome Ardeche; Hopital De Jour
  - Valenciennes, France, 59300
    - Clinique Onco Des Dentellieres; Chimiotherapie Radiotherapie
Germany
- - Bamberg, Germany, 96049
    - Klinikum am Bruderwald; Frauenklinik
  - Bremen, Germany, 28211
    - Gynaekologicum Bremen; Prof. Dr. Willibald Schröder
  - Erlangen, Germany, 91054
    - Universitätsklinikum Erlangen; Frauenklinik
  - Essen, Germany, 45122
    - Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
  - Esslingen, Germany, 73730
    - Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe
  - Frankfurt, Germany, 60431
    - AGAPLESION Markus-Krankenhaus
  - Gera, Germany, 07548
    - SRH Wald-Klinikum Gera; Klinik für Frauenheilkunde und Geburtshilfe
  - Hamburg, Germany, 20246
    - Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
  - Hannover, Germany, 30177
    - Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding
  - Heidelberg, Germany, 69120
    - Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
  - Homburg/Saar, Germany, 66424
    - Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe
  - Limburg, Germany, 65549
    - St.-Vincenz-Krankenhaus; Frauenklinik
  - Lübeck, Germany, 23538
    - Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
  - Mönchengladbach, Germany, 41061
    - Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
  - München, Germany, 81675
    - Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde
  - Neuruppin, Germany, 16816
    - Ruppiner Kliniken, Klinik fuer Gynaekologie und Geburtshilfe
  - Rotenburg/Wümme, Germany, 27356
    - Agaplesion Diakonieklinikum Rotenburg
  - Saarbruecken, Germany, 66113
    - Praxis Dr. Wagner
  - Torgau, Germany, 04860
    - Kreiskrankenhaus Torgau; Abt.Gynäkologie und Geburtshilfe
  - Tübingen, Germany, 72076
    - Universitätsklinik Tübingen; Frauenklinik
Greece
- - Athens, Greece, 115 22
    - Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine
  - Crete, Greece, 711 10
    - University General Hospital of Heraklion
  - Patras, Greece, 265 04
    - University Hospital of Patras Medical Oncology
  - Thessaloniki, Greece, 564 29
    - Papageorgiou General Hospital; Medical Oncology
  - Thessaloniki, Greece, 546 45
    - Euromedical General Clinic of Thessaloniki; Oncology Department
  - Αθηνα, Greece, 115 27
    - Hippokratio Hospital; 2Nd Internal Medicine
  - Λαρισα, Greece, 413 35
    - University Hospital of Larissa; Oncology
Hong Kong
- - Hong Kong, Hong Kong
    - Queen Elizabeth Hospital; Clinical Oncology
Hungary
- - Budapest, Hungary, 1097
    - Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X
  - Budapest, Hungary, 1032
    - Szent Margit Hospital; Dept. of Oncology
  - Budapest, Hungary, 1122
    - Orszagos Onkologial Intezet; Onkologiai Osztaly X
  - Debrecen, Hungary, 4032
    - Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
  - Miskolc, Hungary, 3501
    - Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
  - Szeged, Hungary, 6720
    - Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
Israel
- - Beer Sheva, Israel, 8410100
    - Soroka Medical Center; Oncology Dept
  - Haifa, Israel, 3109601
    - Rambam Medical Center; Oncology
  - Holon, Israel, 5822012
    - Wolfson Hospital; Oncology
  - Jerusalem, Israel, 9103102
    - Shaare Zedek Medical Center; Oncology Dept
  - Jerusalem, Israel, 9112000
    - Hadassah Ein Karem Hospital; Oncology Dept
  - Nahariya, Israel, 22100
    - Nahariya Hospital; Oncology
  - Petach Tikva, Israel, 4941492
    - Rabin Medical Center; Oncology Dept
  - Ramat Gan, Israel, 5262100
    - Chaim Sheba Medical Center; Oncology Dept
  - Rehovot, Israel, 7610001
    - Kaplan Medical Center; Oncology Inst.
  - Tel Aviv, Israel, 6423906
    - Sourasky / Ichilov Hospital; Dept. of Oncology
  - Tel Aviv, Israel
    - Assuta Medical Centre; Oncology
  - Zerifin, Israel, 6093000
    - Assaf Harofeh; Oncology
Italy
- Campania
  - Avellino, Campania, Italy, 83100
    - Azienda Ospedaliera San Giuseppe Moscati
- Emilia-Romagna
  - Piacenza, Emilia-Romagna, Italy, 29100
    - Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia
  - Ravenna, Emilia-Romagna, Italy, 48100
    - Azienda USL di Ravenna; Unità Operativa di Oncologia Medica
- Friuli-Venezia Giulia
  - Udine, Friuli-Venezia Giulia, Italy, 33100
    - Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
- Lazio
  - Viterbo, Lazio, Italy, 01100
    - Ospedale Belcolle Di Viterbo; Oncologia
- Liguria
  - Genova, Liguria, Italy, 16128
    - Ente Ospedaliero Ospedali Galliera; S.C. Oncologia Medica
- Lombardia
  - Bergamo, Lombardia, Italy, 24127
    - Asst Papa Giovanni XXIII; Oncologia Medica
  - Legnago, Lombardia, Italy, 37045
    - Ospedale Mater Salutis; Dept of Oncology
  - Milano, Lombardia, Italy, 20141
    - Istituto Europeo Di Oncologia
  - Milano, Lombardia, Italy, 20132
    - Irccs Ospedale San Raffaele;Oncologia Medica
  - Pavia, Lombardia, Italy, 27100
    - Irccs Policlinico S. Matteo - Uni Pavia; Clinica Medica I Div. Med. Int. Onc. Medica E Gastroent.
- Marche
  - Ancona, Marche, Italy, 60121
    - Ospedali Riuniti Di Ancona; Oncology
  - Macerata, Marche, Italy, 62100
    - Ospedale Di Macerata; Oncologia
- Piemonte
  - Novara, Piemonte, Italy, 28100
    - Ospedale Maggiore Della Carita; Oncologia Medica
  - Ponderano (BI), Piemonte, Italy, 13875
    - Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica
  - Torino, Piemonte, Italy, 70060
    - Fondazione Del Piemonte; Medical Oncology
- Sicilia
  - Taormina, Sicilia, Italy, 98030
    - Ospedale S. Vincenzo; Oncologia Medica
- Toscana
  - Firenze, Toscana, Italy, 50139
    - Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
- Veneto
  - Cona (Ferrara), Veneto, Italy, 44124
    - Arcispedale S.Anna; Oncologia Medica
Lebanon
- - Beirut, Lebanon, 2063 1111
    - Hotel Dieu de France; Oncology
  - Beirut, Lebanon, 1107 2020
    - American University of Beirut - Medical Center
Lithuania
- - Kaunas, Lithuania, 50009
    - Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
  - Vilnius, Lithuania, 08660
    - Uni Oncology Inst. ; Chemo - Radiation Dept
Mexico
- - D.f., Mexico, 14050
    - Medica Sur Centro Oncologico Integral
  - D.f., Mexico, 04980
    - Iem-Fucam
  - Distrito Federal, Mexico, 14080
    - Instituto Nacional de Cancerologia; Oncology
  - Mexico City, Mexico, Tlalpan 14000
    - Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán
  - Mexico City, Mexico, 03100
    - Consultorio de Medicina Especializada; Dentro de Condominio San Francisco
  - Mexico City, Mexico, 06720
    - Centro Medico Nacional Siglo Xxi - Imss; Hospital de Oncologia
  - Mexico DF, Mexico, 06726
    - Hospital General de México; Unidad de Oncologia
  - Queretaro, Queretaro, Mexico, 76090
    - Cancerologia de Queretaro; Oncologia
Morocco
- - Rabat, Morocco, 10000
    - Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie
Netherlands
- - Alkmaar, Netherlands, 1815 JD
    - Medisch Centrum Alkmaar
  - Dordrecht, Netherlands, 3318 AT
    - Albert Schweitzer Ziekenhuis
  - Eindhoven, Netherlands, 5623 EJ
    - Catharina ZKHS; Inwendige Geneeskunde Afd.
  - Groningen, Netherlands, 9728 NT
    - Martini Ziekenhuis; Dept of Internal Medicine
  - Leidschendam, Netherlands, 2262 BA
    - Mc Haaglanden, Locatie Antoniushove; Interne Geneeskunde
  - Rotterdam, Netherlands, 3083 AN
    - Ikazia Ziekenhuis; Interne Oncologie
  - Tilburg, Netherlands, 5042 AD
    - Twee Steden Ziekenhuis - Locatie Tilburg; Interne Geneesekunde
  - Venlo, Netherlands, 5912 BL
    - Vie Curie
Pakistan
- - Islamabad, Pakistan, 44000
    - Shifa International Hospital; Department of Oncology
  - Lahore, Pakistan, 54000
    - Shaukat Khanum Memorial Cancer Hospital; Department of Oncology
  - Lahore, Pakistan, 54600
    - Hameed Latif Hospital; Department of Oncology
Peru
- - Lima, Peru, 18
    - Instituto;Oncologico Miraflores
  - Lima, Peru, Lima 41
    - Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
  - Lima, Peru, Lima11
    - Hospital Nacional LNS dela Policia Nacional del Perú. Unidad Onco; Deapartamento de Oncología
Poland
- - Bialystok, Poland, 15-027
    - Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
  - Kielce, Poland, 25-734
    - Świętokrzyskie Centrum Onkologii; Dział Chemioterapii
  - Kraków, Poland, 30-688
    - Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
  - Lodz, Poland, 93-513
    - Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii; Poradnia Chemioterapii
  - Otwock, Poland, 05-400
    - Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
  - Warszawa, Poland, 02-781
    - Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon
Portugal
- - Coimbra, Portugal, 3000-075
    - IPO de Coimbra; Servico de Oncologia Medica
  - Evora, Portugal, 7000-811
    - Hospital do Espirito Santo; Servico de Oncologia Medica
  - Lisboa, Portugal, 1500-650
    - Hospital da Luz; Departamento de Oncologia Medica
  - Lisboa, Portugal, 1649-035
    - Hospital de Santa Maria; Servico de Oncologia Medica
  - Lisboa, Portugal, 1400-038
    - Centro Clinico Champalimaud; Oncologia Medica
  - Loures, Portugal, 2674-514
    - Hospital Beatriz Angelo; Departamento de Oncologia
  - Porto, Portugal, 4200-072
    - IPO do Porto; Servico de Oncologia Medica
  - Porto, Portugal, 4200-319
    - Hospital de Sao Joao; Servico de Oncologia
Saudi Arabia
- - Riyadh, Saudi Arabia, 11211
    - King Faisal Specialist Hospital & Research Centre; Oncology
  - Riyadh, Saudi Arabia, 22490
    - King Abdul Aziz Medical City, King Fahd National Guard; Oncology
Serbia
- - Belgrade, Serbia, 11000
    - Institute for Onc/Rad Serbia
  - Sremska Kamenica, Serbia, 21204
    - Oncology Institute of Vojvodina
Slovenia
- - Ljubljana, Slovenia, 1000
    - Institute of Oncology Ljubljana
Spain
- - Barcelona, Spain, 08024
    - Hospital Quiron Barcelona; Servicio de Oncologia
  - Barcelona, Spain, 08036
    - Hospital Clínic i Provincial; Servicio de Hematología y Oncología
  - Barcelona, Spain, 08041
    - Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
  - Burgos, Spain, 09006
    - Complejo Asistencial Universitario De Burgos; Servicio de Oncologia
  - Caceres, Spain, 10003
    - Hospital San Pedro De Alcantara; Servicio de Oncologia
  - Girona, Spain, 17007
    - Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia
  - Granada, Spain, 18014
    - Hospital Universitario Virgen de las Nieves; Servicio de Oncologia
  - Guadalajara, Spain, 19002
    - Hospital General Universitario de Guadalajara; Servicio de Oncologia
  - Leon, Spain, 24071
    - Complejo Asistencial Universitario de Leon; Servicio de Oncologia
  - Madrid, Spain, 28034
    - Hospital Ramon y Cajal; Servicio de Oncologia
  - Madrid, Spain, 28050
    - HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
  - Madrid, Spain, 28041
    - Hospital Universitario 12 de Octubre; Servicio de Oncologia
  - Madrid, Spain, 28040
    - Hospital Universitario Clínico San Carlos; Servicio de Oncologia
  - Madrid, Spain, 28033
    - Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
  - Madrid, Spain, 28046
    - Hospital Universitario La Paz; Servicio de Oncologia
  - Madrid, Spain, 28040
    - Fundacion Jimenez Diaz; Servicio de Oncologia
  - Malaga, Spain, 29010
    - Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
  - Murcia, Spain, 30008
    - Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia
  - Murcia, Spain, 30120
    - Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
  - Navarra, Spain, 31008
    - Hospital de Navarra; Servicio de Oncologia
  - Orense, Spain, 32005
    - Complejo Hospitalario de Orense; Servicio de Oncologia
  - Salamanca, Spain, 37007
    - Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
  - Sevilla, Spain, 41009
    - Hospital Universitario Virgen Macarena; Servicio de Oncologia
  - Valencia, Spain, 46015
    - Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
  - Valencia, Spain, 46017
    - Hospital Universitario Dr. Peset
  - Valladolid, Spain, 47005
    - Hospital Clinico Universitario de Valladolid; Servicio de Oncologia
  - Valladolid, Spain, 47010
    - Hospital de Rio Hortega; Servicio de Oncologia
  - Zaragoza, Spain, 50009
    - Hospital Universitario Miguel Servet; Servicio Oncologia
  - Zaragoza, Spain, 50009
    - Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
- Alicante
  - Alcoy, Alicante, Spain, 03804
    - Hospital Virgen de los Lirios; Servicio de Oncologia
  - Elda, Alicante, Spain, 03600
    - Hospital General de Elda; Servicio de Oncologia
- Asturias
  - Gijon, Asturias, Spain, 33394
    - Hospital de Cabueñes; Servicio de Oncologia
- Barcelona
  - Sabadell, Barcelona, Spain, 08208
    - Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
- Cadiz
  - Jerez de La Frontera, Cadiz, Spain, 11407
    - Hospital de Jerez de la Frontera; Servicio de Oncologia
- Castellon
  - Castellon de La Plana, Castellon, Spain, 12002
    - Hospital Provincial de Castellon; Servicio de Oncologia
- Huesca
  - Barbastro, Huesca, Spain, 22300
    - Hospital de Barbastro; Servicio de Oncologia
- Islas Baleares
  - Palma De Mallorca, Islas Baleares, Spain, 07014
    - Hospital Universitario Son Espases
- LA Coruña
  - Santiago de Compostela, LA Coruña, Spain, 15706
    - Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
- LA Rioja
  - Logroño, LA Rioja, Spain, 26006
    - Complejo Hospitalario San Millan - San Pedro; Servicio de Oncologia
- LAS Palmas
  - Las Palmas de Gran Canaria, LAS Palmas, Spain, 35016
    - Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
  - Las Palmas de Gran Canaria, LAS Palmas, Spain, 35020
    - Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia
- Madrid
  - Alcorcon, Madrid, Spain, 28922
    - Fundacion Hospital de Alcorcon; Servicio de Oncologia
  - Leganes, Madrid, Spain, 28911
    - Hospital Severo Ochoa; Servicio de Oncologia
- Navarra
  - Pamplona, Navarra, Spain, 31008
    - Clinica Universitaria de Navarra; Servicio de Oncologia
- Tarragona
  - Reus, Tarragona, Spain, 43204
    - Hospital Universitari Sant Joan de Reus; Servicio de Oncologia
- Tenerife
  - Santa Cruz de Tenerife, Tenerife, Spain, 38010
    - Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia
- Valencia
  - Sagunto, Valencia, Spain, 46520
    - Hospital de Sagunto; Servicio de Oncologia
- Vizcaya
  - Bilbao, Vizcaya, Spain, 48013
    - Hospital de Basurto; Servicio de Oncologia
Sweden
- - Gävle, Sweden, 80187
    - Gävle Sjukhus; Onkologiska Kliniken
  - Göteborg, Sweden, 413 45
    - Sahlgrenska Universitetssjukhuset; Jubileumskliniken
  - Karlstad, Sweden, 65185
    - Centralsjukhuset Karlstad, Onkologkliniken
  - Lund, Sweden, 221 85
    - Skånes University Hospital, Skånes Department of Onclology
  - Vaxjo, Sweden, 35185
    - Centrallasarettet Växjö, Onkologkliniken
  - Västerås, Sweden, 72189
    - Västmanlands sjukhus Västerås, Onkologkliniken
Turkey
- - Adana, Turkey, 01250
    - Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
  - Antalya, Turkey, 07070
    - Akdeniz University Medical Faculty; Medical Oncology Department
  - Bornova, İ̇zmi̇r, Turkey, 35100
    - Ege University Medical Faculty; Medical Oncology Department
  - Edirne, Turkey, 22770
    - Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
  - Sihhiye/Ankara, Turkey, 06230
    - Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Ukraine
- - Dnipropetrovsk, Ukraine, 49102
    - Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology
  - Kiev, Ukraine, 03115
    - Kyiv City Clinical Oncological Center; Chemotherapy Department
  - Lviv, Ukraine, 79031
    - State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department
  - Zaporozhye, Ukraine, 69104
    - Zaporozhye Regional Oncology Hospital; Dept of Oncology
United Arab Emirates
- - Al Ain, United Arab Emirates, 15258
    - Tawam Hospital
United Kingdom
- - Bath, United Kingdom, BA1 3NG
    - Royal United Hospital; Oncology Department
  - Birmingham, United Kingdom, B18 7QH
    - City Hospital NHS Trust
  - Bristol, United Kingdom, BS2 8ED
    - Bristol Haematology and Oncology Centre
  - Cambridge, United Kingdom, CB2 2QQ
    - Addenbrookes Hospital; Dept of Oncology
  - Cardiff, United Kingdom, CF14 2TL
    - Velindre Hospital
  - Coventry, United Kingdom, CV2 2DX
    - Walsgrave Hospital
  - Derby, United Kingdom, DE22 3NE
    - Royal Derby Hospital
  - Durham, United Kingdom, DH15TW
    - University Hospital of North Durham
  - East Kilbride, United Kingdom, G75 8RG
    - Hairmyres Hospital; Oncology Dept
  - Eastbourne, United Kingdom, BN21 2UD
    - Eastbourne District Hospital; Department of Pharmacy
  - Glasgow, United Kingdom, G12 0YN
    - Beatson West of Scotland Cancer Centre
  - Grimsby, United Kingdom, DN33 2BA
    - Diana Princess of Wales Hosp.
  - Guildford, United Kingdom, GU2 7XX
    - Royal Surrey County Hospital
  - Leeds, United Kingdom, LS9 7TF
    - Leeds Teaching Hosp NHS Trust;St James's Institute of Onc
  - Lindley, United Kingdom, HD3 3EA
    - Huddersfield Royal Infirmary - Pharmacy department
  - London, United Kingdom, NW3 2QG
    - Royal Free Hospital; Dept of Oncology
  - London, United Kingdom, EC1A 7BE
    - Barts and the London NHS Trust.
  - London, United Kingdom, SE5 9RS
    - Kings College Hospital NHS Foundation Trust
  - London, United Kingdom, SW3 6JJ
    - Royal Marsden Hospital - London
  - Macclesfield, United Kingdom, SK10 3BL
    - Macclesfield District General Hospital
  - Manchester, United Kingdom, M20 4QL
    - Christie Hospital; Breast Cancer Research Office
  - Middlesborough, United Kingdom, TS4 3BW
    - James Cook Uni Hospital
  - New Castle Upon Tyne, United Kingdom, NE7 7DN
    - Freeman Hospital; Northern Centre For Cancer Care
  - Northwood, United Kingdom, HA6 2RN
    - Mount Vernon Cancer Centre
  - Oxford, United Kingdom, OX3 7LJ
    - Churchill Hospital
  - Peterborough, United Kingdom, PE3 9GZ
    - Peterborough City Hospital
  - Plymouth, United Kingdom, PL6 8DH
    - Derriford Hospital; Plymouth Oncology Centre
  - Somerset, United Kingdom, TA1 5DA
    - Musgrove Park Hospital
  - Sutton, United Kingdom, SM2 5PT
    - The Royal Marsden Hospital
  - Truro, United Kingdom, TR1 3LQ
    - Royal Cornwall Hospital
  - Wishaw, United Kingdom, ML2 0DP
    - Wishaw General Hospital
Uruguay
- - Montevideo, Uruguay, 11400
    - Grupo Oncológico Cooperativo Uruguayo; Hospital de Clínicas - Dpto. de Oncología
  - Montevideo, Uruguay, 11600
    - Hospital Pereira Rossell; Oncology Department
  - Montevideo, Uruguay, 11600
    - Hospital Central De Las FF.AA.; Servicio De Oncologia
Venezuela
- - Caracas, Venezuela, 1060
    - Centro Integral de Oncología
  - Caracas, Venezuela, 1080
    - Centro Médico Docente La Trinidad; Servicio de Gastroenterología

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection
HER2-positive breast cancer
Eastern cooperative Oncology Group (ECOG) performance status 0, 1 or 2
LVEF of at least 50 percent (%)

Exclusion Criteria:

Previous systemic non-hormonal anti-cancer therapy for metastatic or locally recurrent disease
Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence less than or equal to (</=) 6 months
Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except for trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
History of persistent Grade 2 or higher (National Cancer Institute Common Toxicity Criteria [NCI-CTC], Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
Central nervous system (CNS) metastases
Current peripheral neuropathy of Grade 3 or greater (NCI-CTC, version 4.0)
History of other malignancy within the last 5 years prior to first study drug administration, except for carcinoma in situ of the cervix or basal cell carcinoma
Inadequate bone marrow, liver or renal function
Uncontrolled hypertension
Hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pertuzumab + Trastuzumab + Taxane Participants will receive pertuzumab and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first. Taxane chemotherapy can be either docetaxel, paclitaxel or nab-paclitaxel as per investigator's choice.	Drug: Docetaxel Participants may receive 'docetaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines. Drug: Nab-paclitaxel Participants may receive 'nab-paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines. Drug: Paclitaxel Participants may receive 'paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines. Drug: Pertuzumab Participants will receive pertuzumab 840 milligrams (mg) IV on Day 1 or Day 2 of Cycle 1, followed by 420 mg IV on Day 1 or Day 2 of each subsequent 3-week cycle. Other Names: RO 43-68451 Drug: Trastuzumab Participants will receive trastuzumab (Herceptin) 8 milligrams per kilogram (mg/kg) IV on Day 1 or Day 2 of Cycle 1, followed by 6 mg/kg IV on Day 1 or Day 2 of each subsequent 3-week cycle, administered in line with the respective product Information and/or recognized clinical practice guidelines. Other Names: Herceptin

Participant Group / Arm

Intervention / Treatment

Experimental: Pertuzumab + Trastuzumab + Taxane

Participants will receive pertuzumab and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first. Taxane chemotherapy can be either docetaxel, paclitaxel or nab-paclitaxel as per investigator's choice.

Drug: Docetaxel

Participants may receive 'docetaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.

Drug: Nab-paclitaxel

Participants may receive 'nab-paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.

Drug: Paclitaxel

Participants may receive 'paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.

Drug: Pertuzumab

Participants will receive pertuzumab 840 milligrams (mg) IV on Day 1 or Day 2 of Cycle 1, followed by 420 mg IV on Day 1 or Day 2 of each subsequent 3-week cycle.

Other Names:

RO 43-68451

Drug: Trastuzumab

Participants will receive trastuzumab (Herceptin) 8 milligrams per kilogram (mg/kg) IV on Day 1 or Day 2 of Cycle 1, followed by 6 mg/kg IV on Day 1 or Day 2 of each subsequent 3-week cycle, administered in line with the respective product Information and/or recognized clinical practice guidelines.

Other Names:

Herceptin

What is the study measuring?

Primary Outcome Measures

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Bachelot T, Ciruelos E, Schneeweiss A, Puglisi F, Peretz-Yablonski T, Bondarenko I, Paluch-Shimon S, Wardley A, Merot JL, du Toit Y, Easton V, Lindegger N, Miles D; PERUSE investigators. Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE). Ann Oncol. 2019 May 1;30(5):766-773. doi: 10.1093/annonc/mdz061.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2012

Primary Completion (Actual)

September 20, 2019

Study Completion (Actual)

September 20, 2019

Study Registration Dates

First Submitted

April 3, 2012

First Submitted That Met QC Criteria

April 4, 2012

First Posted (Estimate)

April 5, 2012

Study Record Updates

Last Update Posted (Actual)

September 25, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

MO28047
2011-005334-20 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Neoplasms

Emory University
Eisai Inc.

Terminated

Trial of Eribulin Followed by Doxorubicin & Cyclophosphamide for Her2-negative, Locally Advanced Breast Cancer

Breast Cancer | Breast Neoplasms | Breast Tumors | Neoplasms, Breast | Cancer of the Breast | Tumors, Breast

United States
Innocrin Pharmaceutical

Completed

CYP17 Lyase and Androgen Receptor Inhibitor Treatment With Seviteronel Trial (INO-VT-464-006; NCT02580448) (CLARITY-01)

Breast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the Breast

United States
G1 Therapeutics, Inc.

Terminated

Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)

Breast Cancer | Breast Neoplasm | Triple-Negative Breast Cancer | Triple-Negative Breast Neoplasms

United States, Bulgaria, Croatia, Slovenia, Serbia, Belgium, North Macedonia, Slovakia
Seagen Inc.

Completed

A Safety Study of SGN-LIV1A in Breast Cancer Patients

Triple Negative Breast Neoplasms | Hormone Receptor Positive Breast Neoplasms | HER2 Positive Breast Neoplasms | HER2 Mutations Breast Neoplasms

United States
University of Washington
National Cancer Institute (NCI)

Completed

Sunitinib Malate, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide Before Surgery in Treating Patients With Stage IIB-IIIC Breast Cancer

Inflammatory Breast Cancer | Male Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer

United States
Providence Health & Services
Brooklyn ImmunoTherapeutics, LLC

Active, not recruiting

Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC)

Breast Neoplasm | Triple Negative Breast Cancer | Breast Neoplasm, Male

United States
Sidney Kimmel Cancer Center at Thomas Jefferson...
Celgene Corporation

Terminated

Romidepsin and Abraxane in Treating Patients With Metastatic Inflammatory Breast Cancer

Inflammatory Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Recurrent Breast Cancer | HER2-negative Breast Cancer

United States
Joseph Baar, MD, PhD

Completed

MUC1 Vaccine for Triple-negative Breast Cancer

Breast Cancer | Stage I Breast Cancer | Inflammatory Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer

United States
Wake Forest University Health Sciences
Merck Sharp & Dohme LLC

Completed

Pilot Study of Paclitaxel Plus Pembrolizumab in Metastatic HER2-Negative Breast Cancer (PePPy)

Male Breast Cancer | Breast - Female

United States
GlaxoSmithKline

Completed

Lapatinib in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer

Metastatic Breast Cancer | Neoplasms, Breast

Japan

Clinical Trials on Docetaxel

Nereus Pharmaceuticals, Inc.

Completed

Phase 1/2 Study of Vascular Disrupting Agent NPI-2358 + Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer

Cancer

United States, Australia, India, Chile, Brazil, Argentina
Tianjin Medical University Cancer Institute and...

Recruiting

Phase II Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With Anlotinib Capsule and Chemotherapy in the Treatment of Immunoresistant Advanced Non-small Cell Lung Cancer

Non-small-cell Lung Cancer

China
Zhuhai Beihai Biotech Co., Ltd

Completed

A Bioequivalence Study of Docetaxel Injection in Patients With Solid Tumours

Solid Tumours | Bioequivalence | Docetaxel

India
Jiangsu HengRui Medicine Co., Ltd.
Shanghai Pulmonary Hospital, Shanghai, China

Completed

A Study of Famitinib Plus Docetaxel in Patients With Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC)

Non-Small Cell Lung Cancer (NSCLC)

China
National Cancer Center, Korea
Seoul National University Bundang Hospital; Gachon University Gil Medical Center and other collaborators

Unknown

Docetaxel Versus Docetaxel Plus Cisplatin Versus Docetaxel Plus S-1 as Second-line Chemotherapy in Metastatic Gastric Cancer

Gastric Cancer

Korea, Republic of
Optimal Health Research

Completed

A Novel Approach for Alleviating the Side Effects of Chemotherapeutic Agents.

Breast Cancer | Lung Cancer | Prostate Cancer

United States
Arog Pharmaceuticals, Inc.

Withdrawn

A Phase 2 Study in Patients With Advanced Non-Small Cell Lung Cancer Using New Agents With and Without Docetaxel.

Carcinoma, Non-Small-Cell Lung
Boehringer Ingelheim

Completed

BIBF 1120 + Docetaxel (Japan) in Patients With Advanced Non-small-cell Lung Cancer, Phase I

Carcinoma, Non-Small-Cell Lung

Japan
Sanofi

Completed

Study of Combination Docetaxel and Radiotherapy With or Without Cisplatin to Treat Local Advanced Head and Neck Cancer (TAX200006)

Head and Neck Neoplasms

France
Sanofi

Completed

Pulmonart: Docetaxel - Non-Small Cell Lung Cancer (NSCLC)

Lung Neoplasms

France, Netherlands, Spain, Turkey, Belgium, Finland, Italy, United Kingdom

Outcome Measure	Measure Description	Time Frame
Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) Time Frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. TEAEs of special interest included LVEF decreased, liver enzymes increased, and suspected transmission of infectious agent by the study drug.	From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) Time Frame: The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	All adverse events leading to death, regardless of whether they were classified as treatment emergent, are listed by system organ class (SOC) and preferred term (PT) according to the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. Admin. = administration; Mediast. = mediastinal	The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) Time Frame: The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	All adverse events leading to death, regardless of whether they were classified as treatment emergent, are listed by system organ class (SOC) and preferred term (PT) according to the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. Admin. = administration; Mediast. = mediastinal	The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term Time Frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs by system organ class (SOC) and preferred term (PT); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. If a participant experienced the same AE at more than one severity grade, only the most severe grade was presented.	From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class Time Frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the system organ classes are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category.	From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term Time Frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category.	From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term Time Frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category. Discont. = discontinuation; Ptz = pertuzumab; Tax = taxane; Trz = trastuzumab	From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term Time Frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category. Interrupt. = interruption; Ptz = pertuzumab; Tax = taxane; Trz = trastuzumab	From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Number of Participants With Treatment-Emergent Adverse Events to Monitor of Any Grade, Occurring in ≥5% of Participants by Category Time Frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first dose of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, it was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. If a participant had more than one event in a category, they were counted only once in that category. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. MedDRA version 22.1 was used to code AEs; AEs may fall within multiple categories.	From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term Time Frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first dose of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, it was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. If a participant had more than one event in a category, they were counted only once in that category. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. MedDRA version 22.1 was used to code AEs; preferred terms (PT) that are part of a given category are listed in the rows directly below each category within the results table.	From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Number of Participants With Treatment-Emergent Adverse Events of Special Interest by Category and Preferred Term Time Frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs of special interest included LVEF decreased, liver enzymes (ALT or AST) increased, and suspected transmission of infectious agent by the study drug. MedDRA version 22.1 was used to code AEs; preferred terms (PT) that are part of a given category are listed in the rows directly below each category within the results table. If a participant experienced more than one event in a category, they were counted only once in that category.	From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab Time Frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.	From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Subgroup Analysis by Age (≤65 vs. >65 Years): Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor Time Frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent.	From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor Time Frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent.	From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Subgroup Analysis by ECOG Performance Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab Time Frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.	From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Subgroup Analysis by Visceral Disease at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab Time Frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.	From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab Time Frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.	From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Subgroup Analysis by Hormone Receptor Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab Time Frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.	From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Subgroup Analysis by Previous Trastuzumab Therapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab Time Frame: From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.	From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Number of Participants With a Congestive Heart Failure Event Time Frame: From Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	Congestive heart failure was defined as the Standardised MedDRA Query (SMQ) 'Cardiac failure (wide)' from the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1).	From Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Time to Onset of the First Episode of Congestive Heart Failure Time Frame: From Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	Congestive heart failure was defined as SMQ 'Cardiac failure (wide)' from the MedDRA version 22.1. Time to onset of the first episode of congestive heart failure was analyzed using a Kaplan-Meier approach. Participants who did not experience any congestive heart failure at the time of data-cut were censored at the date of the last attended visit whilst on-treatment (including visits up to and including 28 days after last dose of study treatment). Only treatment emergent congestive heart failure events are included.	From Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study Time Frame: Baseline, predose on Day 1 of every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	All participants must have had a baseline LVEF ≥50% to enroll in the study; patients with significant cardiac disease or baseline LVEF below 50% were not eligible for this study. The change from baseline LVEF values were reported at every 3 cycles over the course of the study and at the final treatment, worst treatment, and maximum decrease values. The final treatment value was defined as the last LVEF value observed before all study treatment discontinuation. The worst treatment value was defined as the lowest LVEF value observed before all study treatment discontinuation. The maximum decrease value was defined as the largest decrease of LVEF value from baseline, or minimum increase if a participant's post-baseline LVEF measures were all larger than the baseline value.	Baseline, predose on Day 1 of every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study Time Frame: Baseline, predose on Day 1 of every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	All participants must have had a baseline LVEF greater than or equal to (≥)50% to enroll in the study; patients with significant cardiac disease or baseline LVEF below 50% were not eligible for this study. The number of participants are reported according to four change from baseline in LVEF value categories over the course of the study: 1) an increase or decrease from baseline LVEF less than (<)10% points or no change in LVEF; 2) an absolute LVEF value <45% points and a decrease from baseline LVEF ≥10% points to <15% points; 3) an absolute LVEF value <45% points and a decrease from baseline LVEF ≥15% points; or 4) an absolute LVEF value ≥45% points and a decrease from baseline LVEF ≥10% points. BL = baseline; Decr. = decrease; Incr. = increase	Baseline, predose on Day 1 of every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 Time Frame: Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	Clinical laboratory tests for hematology and coagulation parameters were performed at local laboratories. Laboratory toxicities were defined based on NCI-CTC v4.0 from Grades 1 (least severe) to 4 (most severe). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.	Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria Time Frame: Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	Clinical laboratory tests for hematology and coagulation parameters were performed at local laboratories. Laboratory toxicities were defined based on local laboratory normal ranges (for parameters with NCI-CTC grade not defined). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.	Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 Time Frame: Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	Clinical laboratory tests for biochemistry parameters were performed at local laboratories. Laboratory toxicities were defined based on NCI-CTC v4.0 from Grades 1 (least severe) to 4 (most severe). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.	Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria Time Frame: Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	Clinical laboratory tests for biochemistry parameters were performed at local laboratories. Laboratory toxicities were defined based on local laboratory normal ranges (for parameters with NCI-CTC grade not defined). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.	Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival, as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) Time Frame: From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.	From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Subgroup Analysis by Region of Enrollment: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 Time Frame: From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.	From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Subgroup Analysis by Age (≤65 vs. >65 Years): Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 Time Frame: From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.	From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Subgroup Analysis by ECOG Performance Status at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 Time Frame: From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.	From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Subgroup Analysis by Taxane Chemotherapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 Time Frame: From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.	From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Subgroup Analysis by Visceral Disease at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 Time Frame: From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.	From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 Time Frame: From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.	From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Subgroup Analysis by Hormone Receptor Status at Baseline: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 Time Frame: From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.	From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Subgroup Analysis by Previous Trastuzumab Therapy: Progression-Free Survival, as Assessed by the Investigator Using RECIST v1.1 Time Frame: From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	Progression-free survival (PFS) was defined as the time between the date of enrollment and the date of first radiographically documented progressive disease assessment (by the investigator using RECIST v1.1) or death, whichever occurred first. PFS was analyzed using a Kaplan-Meier approach. Participants who had neither progressed nor died at the time of clinical cut-off or who were lost to follow-up were censored at the date of the last evaluable tumor assessment (response assessment with the latest end date); if no post-baseline assessments were available, such participants were censored at Day 1. If a participant missed 2 or more consecutive visits, then they were censored at the last evaluable visit prior to the missed visits. Tumor assessments were performed every 3 cycles (1 cycle is 3 weeks) for up to 36 months and at least every 12 cycles thereafter during treatment, and at least every 36 weeks post-treatment (if progression-free after 36 months), until disease progression.	From date of enrollment until date of disease progression or death, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Overall Survival Time Frame: From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.	From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Subgroup Analysis by Region of Enrollment: Overall Survival Time Frame: From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.	From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Subgroup Analysis by Age (≤65 vs. >65 Years): Overall Survival Time Frame: From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.	From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Subgroup Analysis by ECOG Performance Status at Baseline: Overall Survival Time Frame: From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.	From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Subgroup Analysis by Taxane Chemotherapy: Overall Survival Time Frame: From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.	From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Subgroup Analysis by Visceral Disease at Baseline: Overall Survival Time Frame: From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.	From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Overall Survival Time Frame: From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.	From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Subgroup Analysis by Hormone Receptor Status at Baseline: Overall Survival Time Frame: From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.	From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Subgroup Analysis by Previous Trastuzumab Therapy: Overall Survival Time Frame: From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	Overall survival was defined as time from the date of enrollment until the date of death due to any cause. Overall survival was analyzed using a Kaplan-Meier approach. Participants who had not died were censored at the last date they were known to be alive. When it was not possible to confirm the full death date, partial death dates were imputed to: 01 June of that year if only the year was known, 15th of that month if only the month and year were known. If the imputed date was before the last known alive date, the last known alive date was used as the imputation.	From date of enrollment until death due to any cause. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1 Time Frame: Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	The overall response rate was defined as the percentage of participants with complete response (CR) or partial response (PR) as their best confirmed response (≥4 weeks later), as assessed by the investigator using RECIST v1.1 from the start of study treatment until disease progression/recurrence or death. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants without post-baseline tumor assessments were considered non-responders.	Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Percentage of Participants by Best Overall Response as Assessed by the Investigator Using RECIST v1.1 Time Frame: Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	Best overall response (BOR) was defined as the best response recorded from the first dose of study treatment until disease progression/recurrence or death in the absence of disease progression. The hierarchy used to determine BOR: Complete Response (CR)>Partial Response (PR)>Stable Disease (SD)>Progressive Disease (PD)>Not Evaluable. Note that CR or PR was confirmed ≥4 weeks later. RECIST v1.1 responses are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.; PD = At least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study, and absolute increase of ≥5 mm.; SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.	Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Subgroup Analysis by Age (≤65 vs. >65 Years): Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1 Time Frame: Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	The overall response rate was defined as the percentage of participants with complete response (CR) or partial response (PR) as their best confirmed response (≥4 weeks later), as assessed by the investigator using RECIST v1.1 from the start of study treatment until disease progression/recurrence or death. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants without post-baseline tumor assessments were considered non-responders.	Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Subgroup Analysis by Taxane Chemotherapy: Overall Response Rate (Complete Response or Partial Response) Based on Best Overall Response (Confirmed) as Assessed by the Investigator Using RECIST v1.1 Time Frame: Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	The overall response rate was defined as the percentage of participants with complete response (CR) or partial response (PR) as their best confirmed response (≥4 weeks later), as assessed by the investigator using RECIST v1.1 from the start of study treatment until disease progression/recurrence or death. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants without post-baseline tumor assessments were considered non-responders.	Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression or death. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Clinical Benefit Rate (CR or PR, or SD for at Least 6 Months) Based on Best Overall Response as Assessed by the Investigator Using RECIST v.1.1 Time Frame: Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	The clinical benefit rate was defined as the percentage of participants whose best confirmed response (≥4 weeks later) was a complete response (CR) or partial response (PR), or stable disease (SD) that lasted at least 6 months, as assessed by the investigator using RECIST v1.1 from the start of study treatment until disease progression/recurrence or death. Clinical benefit responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.; SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least 20% increase in sum of diameters of target lesions and absolute increase of ≥5 mm), taking as reference the smallest sum diameters while on study.	Assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter, until disease progression. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Duration of Response as Assessed by the Investigator Using RECIST v1.1 Time Frame: From date of first confirmed response (CR or PR) to first documented disease progression or death from any cause, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	Duration of response (DOR) was defined as the time from when a confirmed best overall response of complete response (CR) or partial response (PR) was first documented to first documented disease progression or death from any cause (whichever occurred first). DOR was analyzed using a Kaplan-Meier approach. Participants who had not progressed or died after having had a confirmed response were censored at the date of their last tumor measurement. Response was assessed every 3 cycles (1 cycle is 3 weeks) up to 36 months, and at least every 12 cycles thereafter until event occurrence or end of study. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	From date of first confirmed response (CR or PR) to first documented disease progression or death from any cause, whichever occurred first. The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Time to Response for Participants With Best Overall Response of Complete Response or Partial Response, as Assessed by the Investigator Using RECIST v1.1 Time Frame: From date of first study treatment until date of first confirmed response (CR or PR). The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.	Time to response (TTR) was defined as the time from the first study treatment administration to the date of first confirmed response (CR or PR). TTR was analyzed using a Kaplan-Meier approach. Participants who did not have CR or PR were censored at the date of their last evaluable tumor assessment. Participants for whom no post-baseline tumor assessments were available were censored at Day 1. Responses according to RECIST v1.1 are defined as follows: CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimetres (mm).; PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	From date of first study treatment until date of first confirmed response (CR or PR). The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.
Change From Baseline in Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) Questionnaire Total Score Over the Course of the Study Time Frame: Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. Participants were given a series of statements in each subscale and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B total score, ranging from 0 to 148, was the sum of the scores for each subscale, provided that at least 80% of the items had been answered; a higher score indicated a better quality of life. If any of the 5 subscale scores were missing, the total score was also set to missing. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only.	Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Change From Baseline in FACT-B Questionnaire Physical Well-Being Subscale Score Over the Course of the Study Time Frame: Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the physical well-being subscale, participants were given a series of 7 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B physical well-being subscale score, ranging from 0 to 28, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only.	Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Change From Baseline in FACT-B Questionnaire Social Well-Being Subscale Score Over the Course of the Study Time Frame: Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the social well-being subscale, participants were given a series of 7 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B social well-being subscale score, ranging from 0 to 28, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only.	Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Change From Baseline in FACT-B Questionnaire Emotional Well-Being Subscale Score Over the Course of the Study Time Frame: Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the emotional well-being subscale, participants were given a series of 6 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B emotional well-being subscale score, ranging from 0 to 24, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only.	Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Change From Baseline in FACT-B Questionnaire Functional Well-Being Subscale Score Over the Course of the Study Time Frame: Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the functional well-being subscale, participants were given a series of 7 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B functional well-being subscale score, ranging from 0 to 28, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only.	Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
Change From Baseline in FACT-B Questionnaire Breast Cancer Subscale Score Over the Course of the Study Time Frame: Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.	The FACT-B questionnaire (version 4) was administered only to female participants to assess quality of life in five subscales: physical, social, emotional, and functional well-being, and breast cancer. For the breast cancer subscale, participants were given a series of 10 statements and were asked to rate how true each statement was for them during the past 7 days on a 5-point scale ranging from 0 (not at all) to 4 (very much). The calculated FACT-B breast cancer subscale score, ranging from 0 to 40, was the sum of the scores for each statement only if at least 50% of items had been answered; the higher the score, the better the quality of life. Baseline was defined as the last non-missing measurement taken prior to first dose of study treatment (including unscheduled assessments). Post-baseline values were summarized for planned visits only.	Baseline, every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.

A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer (PERUSE)

A Multicenter, Open-Label, Single-Arm Study of Pertuzumab in Combination With Trastuzumab and a Taxane in First Line Treatment of Patients With HER2-Positive Advanced (Metastatic or Locally Recurrent) Breast Cancer

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Breast Neoplasms

Clinical Trials on Docetaxel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations