A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment

A Two-Cohort, Open-Label, Multicenter Study of Trastuzumab Emtansine (T-DM1) in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients Who Have Received Prior Anti-HER2 and Chemotherapy-Based Treatment

This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Trastuzumab Emtansine

• Study Type: Interventional
• Enrollment (Actual): 2185
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1431FWO
    • CEMIC
  • La Rioja, Argentina, F5300COE
    • Centro Oncologico Riojano Integral (CORI)
  • Mar Del Plata, Argentina, 7600
    • Hospital Privado De Comunidad; General Practice
• Australia
  • New South Wales
    • North Sydney, New South Wales, Australia, 2059
      • Mater Hospital; Patricia Ritchie Centre for Cancer Care and Research
    • Waratah, New South Wales, Australia, 2298
      • Calvary Mater Newcastle; Medical Oncology
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital; Medical Oncology and Pallative Care
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Haematology & Oncology Clinics of Australia Research Centre
  • South Australia
    • Kurralta Park, South Australia, Australia, 5037
      • Ashford Cancer Center Research
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Peter MacCallum Cancer Centre; Medical Oncology
    • St Albans, Victoria, Australia
      • Sunshine Hospital; Oncology Research
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
• Austria
  • Salzburg, Austria, 5020
    • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
  • 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
  • Anderlecht, Belgium, 1070
    • Institut Jules Bordet
  • Brussel, Belgium, 1090
    • UZ Brussel
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires St-Luc
  • Charleroi, Belgium, 6000
    • GHdC Site Notre Dame
  • Edegem, Belgium, 2650
    • UZ Antwerpen
  • Gent, Belgium, 9000
    • UZ Gent
  • Leuven, Belgium, 3000
    • UZ Leuven Gasthuisberg
  • Liège, Belgium, 4000
    • CHU Sart-Tilman
  • Namur, Belgium, 5000
    • Clinique Ste-Elisabeth
  • Wilrijk, Belgium, 2610
    • Sint Augustinus Wilrijk, Apotheek
• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 20560-120
      • *X*Instituto Nacional do Cancer - INCA
  • RS
    • Porto Alegre, RS, Brazil, 90610-000
      • Hospital São Lucas - PUCRS
  • SC
    • Florianopolis, SC, Brazil, 88034-000
      • Centro de Pesquisas Oncológicas - CEPON
  • SP
    • Sao Paulo, SP, Brazil, 01308-050
      • Hospital Sirio Libanes; Centro de Oncologia
    • Sao Paulo, SP, Brazil, 01321-001
      • Hospital Sao Jose
• Bulgaria
  • Sofia, Bulgaria, 1303
    • MHAT Serdika; Department of medical oncology
  • Sofia, Bulgaria, 1756
    • SHATO - Sofia
  • Sofia, Bulgaria, 1784
    • SHATOD - Sofia
  • Varna, Bulgaria, 9010
    • District Oncology Dispensary Wit Stationary
• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 1Z2
      • BC Cancer - Surrey
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Dr. H. Bliss Murphy Cancer Centre; Oncology
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials
    • London, Ontario, Canada, N6A 4L6
      • London Regional Cancer Centre
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Southlake Regional Health Center; Community Care Clinic / Oncology
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Hopital Maisonneuve- Rosemont; Oncology
    • Montreal, Quebec, Canada, H3A 1A1
      • Mcgill University - Royal Victoria Hospital; Oncology
• China
  • Beijing, China, 100021
    • Cancer Hospital Chinese Academy of Medical Sciences.
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Beijing, China, 100853
    • Chinese PLA General Hospital
  • Guangzhou, China, 510000
    • Sun yat-sen memorial hospital
  • Guangzhou, China, 510060
    • Sun Yet-sen University Cancer Center
  • Harbin, China, 150081
    • Harbin Medical University Cancer Hospital
  • Nanjing City, China, 211100
    • Jiangsu Cancer Hospital
  • Shanghai City, China, 200120
    • Fudan University Shanghai Cancer Center
  • Tianjin, China, 300060
    • Tianjin Cancer Hospital
  • Zhejiang, China, 310022
    • Zhejiang Cancer Hospital
• Croatia
  • Zagreb, Croatia, 10000
    • Clinical Hospital Centre Zagreb
• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.
  • Herlev, Denmark, 2730
    • Herlev Hospital; Afdeling for Kræftbehandling
  • Hillerod, Denmark, 3400
    • Nordsjællands Hospital, Hillerød, Onkologisk Afdeling
  • København Ø, Denmark, 2100
    • Rigshospitalet; Onkologisk Klinik
  • Odense C, Denmark, 5000
    • Odense Universitetshospital, Onkologisk Afdeling R
  • Roskilde, Denmark, 4000
    • Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium
  • Vejle, Denmark, 7100
    • Vejle Sygehus; Onkologisk Afdeling
• Dominican Republic
  • Santiago, Dominican Republic, 51000
    • Hospital Metropolitano de Santiago
• Ecuador
  • Guayaquil, Ecuador, EC090114
    • Clinica Alcivar, torre 1;Private office
  • Portoviejo, Ecuador, EC130104
    • Hospital Solca Portoviejo; Oncologia
• Estonia
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre Foundation; Oncology Center
• Finland
  • Helsinki, Finland, 00290
    • Helsingin yliopistollinen keskussairaala
  • Kuopio, Finland, 70210
    • KYS Sadesairaala; Syopatautien poliklinikka
  • 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.
  • Avignon, France, 84082
    • Institut Sainte Catherine
  • Besançon, France, 25030
    • Hôpital Jean Minjoz - CHU de Besançon
  • Bordeaux, France, 33030
    • Clinique Tivoli; Chimiotherapie Radiotherapie
  • Bordeaux, France, 33076
    • Institut Bergonie; Oncologie
  • Bordeaux, France, 33077
    • Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
  • Boulogne-billancourt, France, 92100
    • Cli De La Porte De Saint Cloud; Hop De Jour De Chimiotherapie
  • Brest, France, 29609
    • Hopital Morvan; Oncologie - Radiotherapie
  • Caen, France, 14076
    • Centre Francois Baclesse; Radiotherapie
  • Clermont Ferrand, France, 63011
    • Centre Jean Perrin; Oncologie
  • Dijon, France, 21079
    • Centre Georges Francois Leclerc; Oncologie 3
  • Grenoble, France, 38043
    • Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
  • Levallois Perret, France, 92300
    • Centre Hartmann
  • Lille, France, 59020
    • Centre Oscar Lambret; Senologie
  • Limoges, France, 87039
    • Clinique Chenieux; Oncology
  • Lorient, France, 56100
    • Ch Bretagne Sud Site Scorff; Oncologie Medicale
  • Lyon, France, 69008
    • Centre Leon Berard
  • Marseille, France, 13273
    • Institut Paoli Calmettes; Oncologie Medicale
  • Mont-de-marsan, France, 40024
    • Hopital Layne; Medecine Ambulatoire
  • Montpellier, France, 34298
    • Centre Val Aurelle Paul Lamarque; Recherche Clinique
  • Nice, France, 06189
    • Centre Antoine Lacassagne; Hopital De Jour A2
  • Paris, France, 75231
    • Institut Curie; Oncologie Medicale
  • Paris, France, 75970
    • HOPITAL TENON; Cancerologie Medicale
  • Perigueux, France, 24000
    • Polyclinique Francheville; MED CHIMIOTHERAPIE RADIOTHERAPIE
  • Perpignan, France, 66000
    • Centre Catalan D' Oncologie
  • Plerin, France, 22190
    • Clinique Armoricaine Radiologie; Hopital de Jour
  • Poitiers, France, 86021
    • Pole Regional De Cancerologie
  • Reims, France, 51057
    • Polyclinique De Courlancy; Centre Radiotherapie Oncologie
  • Reims CEDEX, France, 51056
    • Institut Jean Godinot; Oncologie Medicale
  • Rennes, France, 35042
    • Centre Eugene Marquis; Unite Huguenin
  • Rouen, France, 76038
    • Centre Henri Becquerel; Oncologie Medicale
  • Saint Herblain, France, 44805
    • Ico Rene Gauducheau; Oncologie
  • St Cloud, France, 92210
    • Centre Rene Huguenin; CONSULT SPECIALISEES
  • Strasbourg, France, 67065
    • Centre Paul Strauss; Oncologie Medicale
  • Toulouse, France, 31059
    • Institut Claudius Regaud; Departement Oncologie Medicale
  • Toulouse, France, 31076
    • Clinique Pasteur; Oncologie Medicale
  • Tours, France, 37044
    • Centre Henry S Kaplan - CHU Bretonneau ; service oncologie
  • Vandoeuvre-les-nancy, France, 54519
    • Centre Alexis Vautrin; Oncologie Medicale
  • Villejuif, France, 94805
    • Institut Gustave Roussy; Pathologie Mammaire
• Germany
  • Augsburg, Germany, 86150
    • Hämatologisch-onkologische Praxis Dr. med. - Heinrich, - Bangerter
  • Berlin, Germany, 10317
    • Praxis Dres. Schilling & Till
  • Bottrop, Germany, 46236
    • Schwerpunktpraxis Onkologie/Hämatologie Dr. Dirk Pott, Dr. Christian Tirier und Carla Verena u.w.
  • Dresden, Germany, 01127
    • Onkozentrum Dres. Göhler
  • Erfurt, Germany, 99085
    • Dres. Joerg Weniger, Annette Bittrich und Berit Schuetze
  • Erlangen, Germany, 91054
    • Universitätsklinikum Erlangen; Frauenklinik
  • Hamburg, Germany, 22081
    • OncoResearch Lerchenfeld GmbH
  • Hamburg, Germany, 22767
    • HOPA MVZ GmbH
  • Hannover, Germany, 30625
    • Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
  • Koblenz, Germany, 56068
    • Institut für Versorgungsforschung in der Onkologie GbR Koblenz
  • Leverkusen, Germany, 51375
    • Klinikum Leverkusen; Med. Klinik III / Onkologie
  • Muenchen, Germany, 81377
    • Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
  • Münster, Germany, 48149
    • Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe
  • Offenbach, Germany, 63069
    • Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
  • Porta Westfalica, Germany, 32457
    • Praxis fur Hamatologie und Onkologie
  • Rostock, Germany, 18059
    • Universitaetsfrauenklinik; Und Poliklinik Am Klinikum
  • Tübingen, Germany, 72076
    • Universitätsklinik Tübingen; Frauenklinik
  • Wiesbaden, Germany, 65199
    • HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie
  • Würzburg, Germany, 97080
    • Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
• Greece
  • Crete, Greece, 711 10
    • University General Hospital of Heraklion
  • Ioannina, Greece, 455 00
    • Uni Hospital of Ioannina; Oncology Dept.
  • Patras, Greece, 265 04
    • University Hospital of Patras Medical Oncology
  • Thessaloniki, Greece, 564 29
    • Papageorgiou General Hospital; Medical Oncology
• Guatemala
  • Guatemala, Guatemala, 01010
    • Centro Oncológico Sixtino / Centro Oncológico SA
• Hong Kong
  • Hong Kong, Hong Kong
    • Princess Margaret Hospital; Oncology
  • Shatin, Hong Kong
    • Prince of Wales Hosp; Dept. Of Clinical Onc
• Hungary
  • Budapest, Hungary, 1051
    • Ogyi, Orszagos Gyogyszereszeti Intezet
  • Budapest, Hungary, 1115
    • Szent Imre Hospital; Dept. of Oncology
  • Budapest, Hungary, 1122
    • Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
  • Budapest, Hungary, H-1077
    • Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely
  • Kaposvar, Hungary, 7400
    • Kaposi Mor County Hospital; Dept. of Oncology
• Iceland
  • Reykjavik, Iceland, 101
    • Landspitali University Hospital, Department of Medical Oncology
• Indonesia
  • Jakarta, Indonesia, 10430
    • Cipto Mangunkusumo General Hospital; Hematology & Oncology
  • Jakarta, Indonesia, 11420
    • Dharmais National Cancer Center
  • Jakarta, Indonesia, 12930
    • MRCCC Siloam Semanggi Hospital
• Ireland
  • Cork, Ireland
    • Cork Uni Hospital; Oncology Dept
  • Dublin, Ireland, 4
    • St Vincent'S Uni Hospital; Medical Oncology
  • Dublin, Ireland, 7
    • Mater Misericordiae Uni Hospital; Oncology
  • Limerick, Ireland
    • University Hospital Limerick - Oncology
• Italy
  • Campania
    • Avellino, Campania, Italy, 83100
      • Azienda Ospedaliera San Giuseppe Moscati
    • Napoli, Campania, Italy, 80131
      • Istituto Nazionale Tumori Fondazione G. Pascale
    • Napoli, Campania, Italy, 80131
      • Università degli Studi Federico II; Clinica di Oncologia Medica
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40133
      • Ospedale Bellaria; U.O. Oncologia Medica
    • Modena, Emilia-Romagna, Italy, 40124
      • A.O.U. Policlinico di Modena
    • Piacenza, Emilia-Romagna, Italy, 29100
      • Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia
  • Friuli-Venezia Giulia
    • Aviano (PN), Friuli-Venezia Giulia, Italy, 33081
      • RCCS - Centro di Riferimento; Oncologia Medica B
    • Udine, Friuli-Venezia Giulia, Italy, 33100
      • Divisione Onc Med dell'Azienda
  • Lazio
    • Roma, Lazio, Italy, 00161
      • Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
    • Sora, Lazio, Italy, 03039
      • Ospedale S.S. Trinità Nuovo; Divisione Oncologia
  • Liguria
    • Genova, Liguria, Italy, 16132
      • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
  • Lombardia
    • Cremona, Lombardia, Italy, 26100
      • ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit
    • Lecco, Lombardia, Italy, 23900
      • ASST DI LECCO; Oncologia Medica
    • Milano, Lombardia, Italy, 20141
      • Istituto Europeo di Oncologia
    • Milano, Lombardia, Italy, 20132
      • Ospedale San Raffaele; Medical Oncology
    • Milano, Lombardia, Italy, 20133
      • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
    • Pavia, Lombardia, Italy, 27100
      • Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica
    • Sesto San Giovanni (MI), Lombardia, Italy, 20099
      • Casa di Cura Multimedica S.p.A.; Dipartimento Oncologico
  • Piemonte
    • Candiolo, Piemonte, Italy, 10060
      • Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
    • Novara, Piemonte, Italy, 28100
      • Ospedale Maggiore Della Carita; Oncologia Medica
    • Torino, Piemonte, Italy, 10126
      • A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica
  • Puglia
    • Brindisi, Puglia, Italy, 72100
      • Ospedale Antonio Perrino; Oncologia Medica
    • Lecce, Puglia, Italy, 73100
      • Ospedale Vito Fazzi; Div. Oncoematologia
  • Sicilia
    • Catania, Sicilia, Italy, 95122
      • Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica
  • Toscana
    • Florence, Toscana, Italy, 50124
      • A.O.U Careggi
    • Pontedera, Toscana, Italy, 56025
      • Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia
    • Prato, Toscana, Italy, 59100
      • Ospedale Misericordia E Dolce; Oncologia Medica
  • Umbria
    • Perugia, Umbria, Italy, 06156
      • Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
  • Veneto
    • Camposampiero, Veneto, Italy, 35012
      • Ospedale Civile; Oncologia Medica
    • Padova, Veneto, Italy, 35128
      • Ospedale Busonera; Oncologia Medica
    • Verona, Veneto, Italy, 37126
      • A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.
• Korea, Republic of
  • Daegu, Korea, Republic of, 41404
    • Kyungpook National University Medical Center
  • Incheon, Korea, Republic of, 405-760
    • Gachon Medical School Gil Medical Center; Medical Oncology
  • Seoul, Korea, Republic of, 03080
    • Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
  • Seoul, Korea, Republic of, 120-752
    • Yonsei University Severance Hospital; Medical Oncology
  • Seoul, Korea, Republic of, 136-705
    • Korea University Anam Hospital; Oncology Haemotology
• Luxembourg
  • Luxembourg, Luxembourg, 1210
    • CHL Hopital Municipal; Oncology
• Mexico
  • D.f., Mexico, 14050
    • Medica Sur Centro Oncologico Integral
  • DF, Mexico, 04110
    • Hospital Hmg Coyoacan
  • Mexico City, Mexico, 06725
    • CENTRO MÉDICO NACIONAL SIGLO XXI; Hospital de Especialidades Oncología
  • Mexico City, Mexico, 14000
    • Inst. Nacional de Cancerologia; Investigacion Clinica
  • Mexico City, Mexico, Tlalpan 14000
    • Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán
  • Mexico CITY (federal District)
    • Mexico City, Mexico CITY (federal District), Mexico, 06726
      • Hospital General de México
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde
  • Breda, Netherlands, 4819 EV
    • Amphia Ziekenhuis
  • Den Haag, Netherlands, 2512 VA
    • MC Haaglanden; Oncologie
  • Deventer, Netherlands, 7416 SE
    • Deventer Ziekenhuis; Interne Geneeskunde
  • Hengelo, Netherlands, 7555 DL
    • Ziekenhuisgroep Twente, Hengelo
  • Hoofddorp, Netherlands, 2134 TM
    • Spaarne Ziekenhuis; Inwendige Geneeskunde
  • Leeuwarden, Netherlands, 8934 AD
    • Medisch Centrum Leeuwarden; Interne
  • Sittard-Geleen, Netherlands, 6162 BG
    • Orbis Medisch Centrum; Inwendige Geneeskunde
  • Tilburg, Netherlands, 5042 AD
    • Twee Steden Ziekenhuis - Locatie Tilburg; Interne Geneesekunde
• Norway
  • Oslo, Norway, 0450
    • Oslo Universitetssykehus HF; Ullevål sykehus
• Panama
  • Panama, Panama, 0832
    • Centro Hemato Oncologico Panama
  • Panama, Panama, 0834-02723
    • Centro Oncologico America
• Peru
  • Lima, Peru, 18
    • Instituto;Oncologico Miraflores
  • Lima, Peru, Lima 41
    • Clinica de Especialidades Medicas
• Poland
  • Bialystok, Poland, 15-027
    • Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
  • Brzozów, Poland, 36-200
    • Szpital Specjalistyczny POO im. ks. B.Markiewicza; Dzienny Oddz Chemioter i Hematologii Onkol
  • Kielce, Poland, 25-734
    • Świętokrzyskie Centrum Onkologii; Dział Chemioterapii
  • Kraków, Poland, 30-688
    • Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
  • Otwock, Poland, 05-400
    • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
  • Rybnik, Poland, 44-200
    • Wojewódzki Szpital Specjalistyczny Nr 3
• Portugal
  • Lisboa, Portugal, 1099-023
    • IPO de Lisboa; Servico de Oncologia Medica
  • Lisboa, Portugal, 1500-650
    • Hospital da Luz; Departamento de Oncologia Medica
  • Porto, Portugal, 4200-072
    • IPO do Porto; Servico de Oncologia Medica
• Slovakia
  • Bratislava, Slovakia, 833 10
    • Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A
  • Trencin, Slovakia, 911 71
    • Fakultna nemocnica Trencín; Onkologicke odd.
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Institute of Oncology Ljubljana
• Spain
  • Alicante, Spain, 3010
    • Hospital General Univ. de Alicante; Servicio de Oncologia
  • Barcelona, Spain, 08003
    • Hospital del Mar; Servicio de Oncologia
  • Barcelona, Spain, 08024
    • Hospital Quiron Barcelona; 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, 18003
    • Hospital Universitario San Cecilio; Servicio de Oncologia
  • Jaen, Spain, 23007
    • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
  • La Coruña, Spain, 15006
    • Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
  • Lerida, Spain, 25198
    • Hospital Universitari Arnau de Vilanova de Lleida; 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
  • Malaga, Spain, 29010
    • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
  • Pontevedra, Spain, 36002
    • Complejo Hospitalario de Pontevedra; Servicio de Oncologia
  • Valencia, Spain, 46009
    • Instituto Valenciano Oncologia; Oncologia Medica
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia; Servicio de oncologia
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet; Servicio Oncologia
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Hospital General Universitario de Elche; Servicio de Oncologia
    • Elda, Alicante, Spain, 03600
      • Hospital General de Elda; Servicio de Oncologia
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Univ. Central de Asturias; Servicio de Oncologia
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
    • Sabadell, Barcelona, Spain, 8208
      • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
  • Cadiz
    • Jerez de La Frontera, Cadiz, Spain, 11407
      • Hospital de Jerez de la Frontera; Servicio de Oncologia
  • Cordoba
    • Córdoba, Cordoba, Spain, 14004
      • Hospital Universitario Reina Sofia; Servicio de Oncologia
  • Guipuzcoa
    • San Sebastian, Guipuzcoa, Spain, 20080
      • Hospital de Donostia; Servicio de Oncologia Medica
  • Islas Baleares
    • Palma De Mallorca, Islas Baleares, Spain, 07014
      • Hospital Universitario Son Espases
  • 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
    • Leganes, Madrid, Spain, 28911
      • Hospital Severo Ochoa; Servicio de Oncologia
    • Pozuelo de Alarcon, Madrid, Spain, 28223
      • Hospital Quiron de Madrid; Servicio de Oncologia
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • Hospital Xeral Cíes; Servicio de Oncologia
  • Tarragona
    • Reus, Tarragona, Spain, 43204
      • Hospital Universitari Sant Joan de Reus; Servicio de Oncologia
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48903
      • Hospital de Cruces; Servicio de Oncologia
• Sweden
  • Stockholm, Sweden, 171 76
    • Karolinska Hospital; Oncology - Radiumhemmet
  • Umeå, Sweden
    • Norrlands universitetssjukhus; Onkologkliniken
• Taiwan
  • Tainan, Taiwan, 704
    • National Cheng Kung Uni Hospital; Surgery
  • Tainan, Taiwan, 710
    • Chi-Mei Medical Centre; Hematology & Oncology
  • Taipei, Taiwan, 00112
    • VETERANS GENERAL HOSPITAL; Department of General Surgery
• Thailand
  • Bangkok, Thailand, 10330
    • Department of Surgery, King Chulalongkorn Memorial Hospital
  • Bangkok, Thailand, 10400
    • Pramongkutklao Hospital; Medicine - Medical Oncology Unit
  • Chiang Mai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
• Turkey
  • Ankara, Turkey, 06500
    • Gazi Uni Medical Faculty Hospital; Oncology Dept
  • Gaziantep, Turkey, 27310
    • Gaziantep University Medical Faculty, Medical Oncology Department
  • Istanbul, Turkey, 34093
    • Bezmialem Vakif Univ Medical; Bezmialem Vakif Univ T
  • Istanbul, Turkey, 34300
    • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
  • Istanbul, Turkey, 34390
    • Istanbul Uni of Medicine Faculty; Oncology Dept
  • Istanbul, Turkey, 34865
    • Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department
  • Istanbul, Turkey, 34890
    • Marmara Uni Faculty of Medicine; Medical Oncology
  • Izmir, Turkey, 35100
    • Ege Uni Medical Faculty Hospital; Oncology Dept
  • Izmir, Turkey, 35340
    • Dokuz Eylul Uni ; Medical Oncology
  • Izmit, Turkey, 31380
    • Kocaeli University Faculty of Medicine; Medical oncology
• United Arab Emirates
  • Al Ain, United Arab Emirates, 15258
    • Tawam Hospital
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZN
    • Aberdeen Royal Infirmary
  • Birmingham, United Kingdom, B17 0NH
    • University Hospital Birmingham Queen Elizabeth Hospital
  • Canterbury, United Kingdom, CT1 3NG
    • Kent & Canterbury Hospital
  • Coventry, United Kingdom, CV2 2DX
    • University Hospital coventry; Oncology Department
  • Eastbourne, United Kingdom, BN21 2UD
    • Eastborne District General Hospital
  • Edinburgh, United Kingdom, EH4 2XU
    • Western General Hospital; Clinical Oncology
  • Epping, United Kingdom, CM16 6TN
    • St Margaret'S Hospital; Breast Unit
  • Exeter, United Kingdom, EX2 5DW
    • Royal Devon & Exeter Hospital; Oncology Centre
  • Glasgow, United Kingdom, G12 0YN
    • Beatson West of Scotland Cancer Centre
  • Grimsby, United Kingdom, DN33 2BA
    • Diana Princess of Wales Hosp.
  • Huddersfield, United Kingdom, HD3 3EA
    • Huddersfield Royal Infirmary
  • Hull, United Kingdom, HU16 5JQ
    • Castle Hill Hospital; The Queen's Centre for Oncology & Haematology
  • Ipswich, United Kingdom, IP4 5PD
    • Ipswich Hospital; Oncology Pharmacy
  • Lancaster, United Kingdom, LA1 4RP
    • Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust
  • London, United Kingdom, NW3 2QG
    • Royal Free Hospital; Dept of Oncology
  • London, United Kingdom, SE1 9RT
    • Guys & St Thomas Hospital; Department of Oncology
  • London, United Kingdom, SW17 ORE
    • St George'S Hospital; Oncology Research Office /Oncology Opd
  • London, United Kingdom, W1G 6AD
    • Sarah Cannon Research Institute
  • Maidstone, United Kingdom, ME16 9QQ
    • Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
  • Manchester, United Kingdom, M20 4QL
    • Christie Hospital; Breast Cancer Research Office
  • Middlesex, United Kingdom, HA6 2RN
    • Mount Vernon Hospital
  • Plymouth, United Kingdom, PL6 8DH
    • Plymouth Oncology Centre; Clinical Trials Unit
  • Portsmouth, United Kingdom, PO6 3LY
    • Queen Alexandra Hospital, Portsmouth
  • Romford, United Kingdom, RM7 0AG
    • Queen's Hospital; Oncology
  • Sheffield, United Kingdom, S10 2SJ
    • Weston Park Hospital; Cancer Clinical Trials Centre
  • Shrewsbury, United Kingdom, SY3 8XQ
    • Royal Shrewsbury Hospital
  • Swansea, United Kingdom, SA2 8QA
    • Singleton Hospital; Pharmacy
  • Yeovil, United Kingdom, BA21 4AT
    • Yeovil District Hospital; Macmillan Cancer Unit
  • York, United Kingdom, YO31 8HE
    • York District Hospital
• Venezuela
  • Barcelona, Venezuela, 6001
    • Unidad de Mastologia y Atencion a la Mujer
  • Caracas, Venezuela, 1010
    • Instituto Oncologico Luis razetti
  • Caracas, Venezuela, 1020
    • Instituto de Oncologia y Hematologia UCV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• HER2-positive disease determined locally
• Histologically or cytologically confirmed invasive breast cancer
• Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced or metastatic setting must include both chemotherapy, alone or in combination with another agent, and an anti-HER2 agent, alone or in combination with another agent
• Documented progression of incurable, unresectable, LABC, or mBC, defined by the investigator: progression must occur during or after most recent treatment for LABC/mBC or within 6 months of completing adjuvant therapy
• Measurable and/or non-measurable disease
• Left ventricular ejection fraction (LVEF) >/=50% by either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
• Adequate organ function
• Use of highly effective contraception as defined by the protocol

Exclusion Criteria:

• History of treatment with trastuzumab emtansine
• Prior enrollment into a clinical study containing trastuzumab emtansine regardless of having received trastuzumab emtansine or not
• Peripheral neuropathy of Grade >/= 3 per National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v 4.0
• History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer
• History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to first study treatment except hormone therapy, which can be given up to 7 days prior to first study treatment; recovery of treatment-related toxicity consistent with other eligibility criteria
• History of exposure to cumulative doses of anthracyclines
• History of radiation therapy within 14 days of first study treatment. The participant must have recovered from any resulting acute toxicity (to Grade </=1) prior to first study treatment.
• Metastatic central nervous system (CNS) disease only
• Brain metastases which are symptomatic
• History of a decrease in LVEF to less than (<) 40% or symptomatic congestive heart failure (CHF) with previous trastuzumab treatment
• History of symptomatic CHF (New York Heart Association [NYHA] Classes II-IV) or serious cardiac arrhythmia requiring treatment
• History of myocardial infarction or unstable angina within 6 months of first study treatment
• Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy
• Current severe, uncontrolled systemic disease (clinically significant cardiovascular, pulmonary, or metabolic disease)
• Pregnancy or lactation
• Currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
• History of intolerance (such as Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins or any component of the product

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trastuzumab Emtansine (All Participants); This cohort will enroll all participants with HER2-positive, unresectable, LABC or mBC who have received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants will receive trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.	Drug: Trastuzumab Emtansine; Participants will receive trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenously on Day 1 of a 3-week cycle every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.; Other Names: RO5304020, T-DM1, Kadcyla
Experimental: Trastuzumab Emtansine (Asian Participants); This cohort will enroll Asian race participants with HER2-positive, unresectable, LABC or mBC who have received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants will receive trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.	Drug: Trastuzumab Emtansine; Participants will receive trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenously on Day 1 of a 3-week cycle every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.; Other Names: RO5304020, T-DM1, Kadcyla

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Adverse Events of Primary Interest (AEPIs)	The AEPIs in this study were defined as the following: adverse events (AEs) Grade >/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade >/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.	Baseline up to approximately 7 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Specific AEPIs	The AEPIs in this study were defined as the following: adverse events (AEs) Grade >/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade >/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.	Baseline up to approximately 7 years
Percentage of Participants With Adverse Events of Special Interest (AESIs)	AESIs included: 1) Potential drug-induced liver injury, which included any potential case of drug-induced liver injury as, assessed by laboratory criteria for Hy's law (AST and/or ALT elevations that were >3 × ULN, Concurrent elevation of total bilirubin >2 × ULN (or clinical jaundice if total bilirubin measures were not available), except in participants with documented Gilbert's syndrome. Those with Gilbert's syndrome, elevation of direct bilirubin >2 × ULN was used instead. 2) Suspected transmission of an infectious agent by study drug was defined as any organism, virus, or infectious particle (e.g., prion protein transmitting transmissible spongiform encephalopathy), pathogenic or non-pathogenic. A transmission of an infectious agent suspected from clinical symptoms or laboratory findings indicating an infection in a participant exposed to a medicinal product.	Baseline up to approximately 7 years
Progression-Free Survival According to Response Evaluation for Solid Tumors (RECIST) Version (v) 1.1 As Per Investigator Assessment	Progression free survival is defined as the time (in months) between the date of first dose and the date of disease progression or death from any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).	Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
Overall Survival	Overall survival is defined as time to death, which is the time from the date of dosing until the date of death, regardless of the cause of death.	Baseline until death (up to approximately 7 years)
Percentage of Participants With Best Overall Response (Complete Response [CR] or Partial Response [PR]) According to RECIST v 1.1 As Per Investigator Assessment	Best Overall Response reported here is the Best confirmed Overall Response. To be assigned a status of PR or CR, i.e., to be a responder, changes in tumor measurements had to be confirmed by repeat assessments that had to be performed no less than 4 weeks after the criteria for response were first met, i.e., participants needed to have two consecutive assessments of PR or CR. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.	Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD]) According to RECIST v 1.1	Clinical Benefit was defined as CR plus PR plus SD. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD: neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.	Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
Duration of Response (DOR) According to RECIST v 1.1	DOR is defined as the period from the date of initial confirmed PR or CR (whichever occurs first) until the date of PD or death from any cause. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).	Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
Time to Response According to RECIST v 1.1	Time to Response is defined as the time from first dose to first documentation of confirmed PR or CR (whichever occurs first). CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.	Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
Number of Hospital Visits	The number of hospital visits were recorded to evaluate the resoruce expenditures while participants were on study treatment.	Baseline up to approximately 7 years
Type of Hospital Visits	The type of hospital visits (intensive care unit (ICU) versus other) were recorded to evaluate the resoruce expenditures while participants were on study treatment. The number of participants with at least one ICU visit are based on the number of participants with at least one hospital visit, in each group.	Baseline up to approximately 7 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Wuerstlein R, Ellis P, Montemurro F, Anton Torres A, Delaloge S, Zhang Q, Wang X, Wang S, Shao Z, Li H, Rachman A, Vongsaisuwon M, Liu H, Fear S, Pena-Murillo C, Barrios C. Final results of the global and Asia cohorts of KAMILLA, a phase IIIB safety trial of trastuzumab emtansine in patients with HER2-positive advanced breast cancer. ESMO Open. 2022 Oct;7(5):100561. doi: 10.1016/j.esmoop.2022.100561. Epub 2022 Sep 7.
• Engebraaten O, Yau C, Berg K, Borgen E, Garred Ø, Berstad MEB, Fremstedal ASV, DeMichele A, Veer LV', Esserman L, Weyergang A. RAB5A expression is a predictive biomarker for trastuzumab emtansine in breast cancer. Nat Commun. 2021 Nov 5;12(1):6427. doi: 10.1038/s41467-021-26018-z.
• Montemurro F, Delaloge S, Barrios CH, Wuerstlein R, Anton A, Brain E, Hatschek T, Kelly CM, Pena-Murillo C, Yilmaz M, Donica M, Ellis P. Trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer and brain metastases: exploratory final analysis of cohort 1 from KAMILLA, a single-arm phase IIIb clinical trial☆. Ann Oncol. 2020 Oct;31(10):1350-1358. doi: 10.1016/j.annonc.2020.06.020. Epub 2020 Jul 5.

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2012
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: October 4, 2012
• First Submitted That Met QC Criteria: October 4, 2012
• First Posted (Estimate): October 8, 2012

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Trastuzumab; Maytansine; Ado-Trastuzumab Emtansine
• Other Study ID Numbers: MO28231; 2012-001628-37 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No