A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer (APHINITY)

November 26, 2025 updated by: Hoffmann-La Roche

A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer

This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4804

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

Argentina
- - San Miguel de Tucumán, Argentina, T4000IAK
    - Centro Médico San Roque
Australia
- New South Wales
  - Lismore, New South Wales, Australia, 2480
    - Lismore Base Hospital
  - Sydney, New South Wales, Australia, 2060
    - Mater Misericordiae Hospital
  - Waratah, New South Wales, Australia, 2298
    - Newcastle Mater Misericordiae Hospital
  - Westmead, New South Wales, Australia, 2145
    - Westmead Hospital
- Queensland
  - Auchenflower, Queensland, Australia, 4066
    - Wesley Medical Centre
  - Brisbane, Queensland, Australia, 4101
    - Mater Hospital
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - Royal Adelaide Hospital
- Tasmania
  - Hobart, Tasmania, Australia, 7000
    - Royal Hobart Hospital
- Victoria
  - EAST Bentleigh, Victoria, Australia, VIC 3165
    - Monash Medical Centre
  - Geelong, Victoria, Australia, 3220
    - Geelong Hospital
  - Heidelberg, Victoria, Australia, 3084
    - Austin Hospital
  - Melbourne, Victoria, Australia, 3000
    - Peter Maccallum Cancer Institute
- Western Australia
  - Perth, Western Australia, Australia, 6009
    - Sir Charles Gairdner Hospital
Austria
- - Graz, Austria, 8036
    - Lkh-Univ. Klinikum Graz
  - Innsbruck, Austria, 6020
    - Tiroler Landeskrankenanstalten Ges.M.B.H.
  - Linz, Austria, 4010
    - Ordensklinikum Linz Barmherzige Schwestern
  - Rankweil, Austria, 6830
    - Lhk Feldkirch
  - Salzburg, Austria, 5020
    - Lkh Salzburg - Univ. Klinikum Salzburg
  - Sankt Veit an der Glan, Austria, 9300
    - A. Ö. Krankenhaus Der Barmherzigen Brüder
  - Vienna, Austria, 1090
    - Medizinische Universität Wien; Klinik für Frauenheilkunde
  - Vienna, Austria, 1090
    - Medizinische Universität Wien; Klinik für Innere Medizin; Abteilung für Onkologie
  - Vienna, Austria, 1130
    - Krankenhaus Der Stadt Wien-Hietzing
  - Vöcklabruck, Austria, 4840
    - Lkh Vöcklabruck
  - Wels, Austria, 4600
    - Klinikum Kreuzschwestern Wels
Belgium
- - Anderlecht, Belgium, 1070
    - Institut Jules Bordet
  - Charleroi, Belgium, 6060
    - GHdC Site Les Viviers
  - Edegem, Belgium, 2650
    - UZ Antwerpen
  - Hasselt, Belgium, 3500
    - Jessa Zkh (Campus Virga Jesse)
  - Kortrijk, Belgium, 8500
    - AZ Groeninge
  - Leuven, Belgium, 3000
    - UZ Leuven Gasthuisberg
  - Liège, Belgium, 4000
    - CHU de Liège (Sart Tilman)
  - Namur, Belgium, 5000
    - Clinique Ste-Elisabeth
  - Wilrijk, Belgium, 2610
    - ZAS Sint Augustinus Wilrijk
Bulgaria
- - Sofia, Bulgaria, 1756
    - SHATO - Sofia
  - Sofia, Bulgaria, 1527
    - UMHAT Tsaritsa Yoanna - ISUL
  - Varna, Bulgaria, 9010
    - SHATOD Dr. Marko Antonov Markov-Varna, EOOD
Canada
- - Québec, Canada, G1J 1Z4
    - Hopital du Saint Sacrement
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Arthur J.E. Child Comprehensive Cancer Center
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Cross Can Inst
- British Columbia
  - Kelowna, British Columbia, Canada, V1Y 5L3
    - BC Cancer Agency, CSI
  - Surrey, British Columbia, Canada, V3V 1Z2
    - BC Cancer ? Surrey
  - Vancouver, British Columbia, Canada, V5Z 4E6
    - BCCA-Vancouver Cancer Centre
  - Victoria, British Columbia, Canada, V8R 6V5
    - BCCA - Vancouver Island Cancer Centre
- Manitoba
  - Winnipeg, Manitoba, Canada, R2H 2A6
    - CancerCare Manitoba
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 2Y9
    - Queen Elizabeth Ii Health Sciences Centre
- Ontario
  - Greater Sudbury, Ontario, Canada, P3E 5J1
    - Northeastern Ontario
  - Hamilton, Ontario, Canada, L8V 5C2
    - Hamilton Health Sciences - Juravinski Cancer Centre
  - Kingston, Ontario, Canada, K7L 5P9
    - Cancer Centre of Southeastern Ontario
  - London, Ontario, Canada, N6A 5A5
    - London Health Sciences Centre
  - Mississauga, Ontario, Canada, L5M 2N1
    - Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre
  - Newmarket, Ontario, Canada, L3Y 2R2
    - Southlake Regional Health Center
  - Ottawa, Ontario, Canada, K1H 1C4
    - Ottawa Regional Cancer Centre
  - St. Catharines, Ontario, Canada, L2R 7C6
    - Niagara Health Systems - St. Catherines General Site
  - Toronto, Ontario, Canada, M5G 1Z5
    - Mount Sinai Hospital
  - Toronto, Ontario, Canada, M5G 1Z5
    - Princess Margaret Cancer Center
  - Toronto, Ontario, Canada, M4N 3M5
    - Sunnybrook Odette Cancer Centre
- Quebec
  - Montreal, Quebec, Canada, H4J 1C5
    - Hopital Sacre-Coeur Research Centre
  - Montreal, Quebec, Canada, H1T 2M4
    - Hopital Maisonneuve- Rosemont
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4T 7T1
    - Allan Blair Cancer Centre
Chile
- - Providencia, Chile, 7501089
    - INTOP
  - Santiago, Chile, 7500921
    - Fundacion Arturo Lopez Perez
China
- - Beijing, China, 100021
    - Cancer Hospital Chinese Academy of Medical Sciences.
  - Beijing, China, 100071
    - The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
  - Changchun, China, 130021
    - The First Hospital of Jilin University
  - Changchun, China, 130012
    - Jilin Cancer Hospital
  - Changsha, China, 410006
    - Hu Nan Provincial Cancer Hospital
  - Chengdu, China, 610072
    - Sichuan Provincial People's Hospital
  - Fujian, China, 350001
    - Fujian Medical University Union Hospital
  - Fuzhou, China, 110016
    - The 900th Hospital of PLA joint service support force
  - Guangzhou, China, 510060
    - Sun Yet-sen University Cancer Center
  - Guangzhou, China, 510080
    - Guangdong General Hospital
  - Hangzhou, China, 310003
    - The First Affiliated Hospital of College of Medicine, Zhejiang University
  - Harbin, China, 150081
    - Harbin Medical University Cancer Hospital
  - Harbin, China, 150081
    - Harbin Medical University Cancer Hospital; Dept. of Breast Surgery
  - Nanchang, China, 330006
    - The 1st Affiliated Hospital of Nanchang Unversity
  - Shanghai, China, 200032
    - Fudan University Shanghai Cancer Center
  - Shanghai, China, 200025
    - Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
  - Shanghai, China, 200080
    - Shanghai First People's Hospital
  - Shanghai, China, 200433
    - Changhai Hospital of Shanghai
  - Shijiazhuang, China, 50011
    - Hebei Medical University Fourth Hospital
  - Wuhan, China, 430030
    - Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
  - Wuhan, China, 430079
    - Hubei Cancer Hospital
  - Wuhan, China, 430022
    - Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
Colombia
- - Bogotá, Colombia
    - Fundacion Cardioinfantil
  - Bogotá, Colombia
    - Inst. Nacional de Cancerologia
  - Medellin-Antioquia, Colombia
    - Hospital Pablo Tobon Uribe
  - Montería, Colombia
    - Oncomedica S.A.
Croatia
- - Split, Croatia, 21000
    - Uni Hospital Split
  - Varaždin, Croatia, 42000
    - General Hospital Varazdin
  - Zagreb, Croatia, 10000
    - Clinical Hospital Centre Zagreb
Czechia
- - Brno, Czechia, 656 53
    - Masarykuv onkologicky ustav
  - Hradec Králové, Czechia, 500 05
    - Fakultni nemocnice Hradec Kralove
  - Olomouc, Czechia, 779 00
    - Fakultni nemocnice Olomouc
  - Pardubice, Czechia, 532 03
    - MULTISCAN, s.r.o., Radiologicke centrum Pardubice
Denmark
- - Aalborg, Denmark, 9000
    - Aalborg Universitetshospital
  - Copenhagen, Denmark, 2100
    - Rigshospitalet
  - Esbjerg, Denmark, 6700
    - Sydvestjysk Sygehus Esbjerg
  - Herlev, Denmark, 2730
    - Herlev Hospital
  - Hillerød, Denmark, 3400
    - Nordsjællands Hospital, Hillerød, Onkologisk Afdeling
  - Næstved, Denmark, 4700
    - Sjællands Universitetshospital, Næstved
  - Odense C, Denmark, 5000
    - Odense Universitetshospital, Onkologisk Afdeling R
  - Roskilde, Denmark, 4000
    - Sygehus Syd Roskilde
  - Vejle, Denmark, 7100
    - Vejle Sygehus
El Salvador
- - El Salvador, El Salvador, 01101
    - Hospital Oncologia
France
- - Amiens, France, 80090
    - Clinique de L Europe
  - Angers, France, 49000
    - ICO Paul Papin
  - Arras, France, 62012
    - HOP Prive Arras Les Bonnettes
  - Avignon, France, 84000
    - Institut Sainte Catherine
  - Bezannes, France, 51430
    - ICONE
  - Bordeaux, France, 33076
    - Institut Bergonié
  - Bordeaux, France, 33300
    - Polyclinique Bordeaux Nord
  - Brest, France, 29200
    - Hopital Augustin Morvan
  - Caen, France, 14076
    - Centre François Baclesse
  - Clermont-Ferrand, France, 63011
    - Centre Jean Perrin
  - Dechy, France, 59187
    - Centre Leonard de Vinci
  - Dijon, France, 21034
    - Centre Georges-François Lecler
  - Grenoble, France, 38000
    - Institut Daniel Hollard
  - La Roche-sur-Yon, France, 85925
    - Centre Hospitalier Departemental Les Oudairies
  - Le Havre, France, 76600
    - Clinique des Ormeaux
  - Lille, France, 59020
    - Centre Oscar Lambret
  - Limoges, France, 87042
    - Hopital DUPUYTREN
  - Lyon, France, 69373
    - Centre Léon Bérard
  - Marseille, France, 13273
    - Institut Paoli Calmettes
  - Montpellier, France, 34298
    - Institut Régional du Cancer Montpellier
  - Nancy, France, 54100
    - Polyclinique de Gentilly
  - Nice, France, 06189
    - Centre Antoine Lacassagne
  - Nîmes, France, 30029
    - Institut de cancerologie du Gard
  - Paris, France, 75231
    - Institut Curie
  - Paris, France, 75651
    - Ch Pitie Salpetriere
  - Plérin, France, 22190
    - Clinique Armoricaine Radiologie
  - Poitiers, France, 86021
    - CHU de Poitiers
  - Périgueux, France, 24000
    - Polyclinique Francheville
  - Reims, France, 51056
    - Institut Jean Godinot
  - Rennes, France, 35042
    - Centre Eugène Marquis
  - Rouen, France, 76038
    - Centre Henri Becquerel
  - Saint Prient En Jarez, France, 42271
    - ICL
  - Saint-Cloud, France, 92210
    - Centre Rene Huguenin
  - Saint-Herblain, France, 44805
    - Ico Rene Gauducheau
  - Strasbourg, France, 67098
    - Hôpital Hautepierre
  - Strasbourg, France, 67010
    - Institut d'oncologie de l'Orangerie
  - Toulouse, France, 31052
    - Institut Claudius Regaud
  - Toulouse, France, 31076
    - Clinique Pasteur
  - Vandœuvre-lès-Nancy, France, 54511
    - Centre Alexis Vautrin
  - Villejuif, France, 94800
    - Institut Gustave Roussy
Germany
- - Amberg, Germany, 92224
    - Gesundheitszentrum St. Marien GmbH
  - Bad Nauheim, Germany, 61231
    - Hochwaldkrankenhaus
  - Berlin, Germany, 14169
    - Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche
  - Berlin, Germany, 13125
    - Helios Klinikum Berlin-Buch
  - Berlin, Germany, 10719
    - Praxis Dr. Schoenegg
  - Bielefeld, Germany, 33604
    - Onkologische Schwerpunktpraxis Bielefeld
  - Bonn, Germany, 53127
    - Universitatsklinikum Bonn
  - Braunschweig, Germany, 38100
    - Praxis Dr. Ralf Lorenz
  - Bremen, Germany, 28209
    - Hämato-Onkologie im Medicum/Home
  - Böblingen, Germany, 71032
    - Klinikum Sindelfingen-Böblingen
  - Chemnitz, Germany, 09116
    - Klinikum Chemnitz gGmbH
  - Cologne, Germany, 50931
    - Uniklinik Köln, Klinik und Poliklinik und Geburtshilfe
  - Cologne, Germany, 50935
    - St. Elisabeth Krankenhaus Köln GmbH
  - Deggendorf, Germany, 94469
    - DONAU ISAR Klinikum Deggendorf
  - Dortmund, Germany, 44137
    - St. Johannes-Hospital
  - Dresden, Germany, 01307
    - Universitätsklinikum "Carl Gustav Carus"
  - Düsseldorf, Germany, 40225
    - Universitatsklinikum Dusseldorf
  - Düsseldorf, Germany, 40235
    - Luisenkrankenhaus GmbH & Co. KG., Brustzentrum
  - Erfurt, Germany, 99085
    - Praxis fur Hamatologie und Onkologie
  - Erlangen, Germany, 91054
    - Universitätsklinikum Erlangen
  - Esslingen am Neckar, Germany, 73730
    - Klinikum Esslingen
  - Frankfurt, Germany, 65929
    - Städtische Kliniken Frankfurt am Main Höchst
  - Frankfurt, Germany, 60596
    - Klinik Johann Wolfgang von Goethe Uni
  - Frankfurt am Main, Germany, 60389
    - Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
  - Freiburg im Breisgau, Germany, 79110
    - Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
  - Fürth, Germany, 90766
    - Dres.Jochen Wilke und Harald Wagner
  - Greifswald, Germany, 17475
    - Universitätsklinikum Greifswald
  - Halle, Germany, 06120
    - Universitätsklinikum Halle (Saale)
  - Hamburg, Germany, 20246
    - Universitatsklinikum Hamburg-Eppendorf
  - Hamelin, Germany, 31785
    - Sana Klinikum Hameln-Pyrmont
  - Hanover, Germany, 30171
    - Diakovere Henriettenstift, Frauenklinik
  - Hanover, Germany, 30177
    - MVZ Onko Medical GmbH Hannover, Ralf Lohse (Geschäftsführer)
  - Heidelberg, Germany, 69120
    - Nationales Centrum für Tumorerkrankungen (NCT)
  - Hildesheim, Germany, 31134
    - Praxisgemeinschaft
  - Homburg/Saar, Germany, 66424
    - Universitätsklinikum des Saarlandes
  - Karlsruhe, Germany, 76135
    - ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG
  - Kassel, Germany, 34125
    - Klinikum Kassel Gmbh
  - Kassel, Germany, 34117
    - Elisabeth-Krankenhaus Brustzentrum
  - Kiel, Germany, 24105
    - UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe
  - Landshut, Germany, 84034
    - Klinikum Landshut Frauenklinik
  - Leipzig, Germany, 04277
    - Sankt Elisabeth Krankenhaus
  - Lichtenberg, Germany, 10367
    - Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
  - Ludwigsfelde, Germany, 14974
    - Evangelisches Krankenhaus
  - Lübeck, Germany, 23562
    - Universitätsklinikum Schleswig-Holstein / Campus Lübeck
  - Mainz, Germany, 55131
    - Universitätsmedizin Mainz
  - Mönchengladbach, Germany, 41061
    - Brustzentrum Rhein-Ruhr Servicegesellschaft mbH
  - München, Germany, 81675
    - Klinikum rechts der Isar der TU München
  - München, Germany, 80336
    - Klinikum der Universität München
  - München, Germany, 80637
    - Rotkreuzklinikum München
  - Münster, Germany, 48149
    - Universitatsklinikum Munster
  - Offenbach, Germany, 63069
    - Sana Klinikum Offenbach GmbH
  - Oldenburg, Germany, 26133
    - Medizinisches Versorgungszentrum am Klinikum Oldenburg GmbH
  - Ravensburg, Germany, 88212
    - Hämatologisch/Onkologische Praxis Prof. Dr. Decker, Studienzentrum
  - Recklinghausen, Germany, 45657
    - Oncologianova GmbH
  - Rosenheim, Germany, 83022
    - RoMed Klinikum Rosenheim
  - Rostock, Germany, 18059
    - Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
  - Stade, Germany, 21680
    - MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -
  - Trier, Germany, 54290
    - Klinikum Mutterhaus der Borromaeerinnen gGmbH
  - Tübingen, Germany, 72076
    - Universitätsklinik Tübingen
  - Ulm, Germany, 89075
    - Universitätsklinikum Ulm Am Michelsberg
  - Velbert, Germany, 42551
    - Dres. Arnd Nusch Naser Ali-Mohammad Kalhori und Werner Langer
  - Villingen-Schwenningen, Germany, 78052
    - Schwarzwald-Baar Klinikum Klinik für Frauenheilkunde und Geburtshilfe
  - Wiesbaden, Germany, 65189
    - St. Josefs-Hospital Wiesbaden
  - Witten, Germany, 58452
    - Marien-Hospital Witten
  - Würzburg, Germany, 97080
    - Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
Guatemala
- - Guatemala City, Guatemala, 01015
    - Grupo Angeles
Hong Kong
- - Hong Kong, Hong Kong
    - Queen Mary Hospital; Dept. of Clinical Oncology
  - Hong Kong, Hong Kong
    - Queen Mary Hospital; Surgery
Hungary
- - Budapest, Hungary, 1122
    - Orszagos Onkologiai Intezet
  - Budapest, Hungary, H-1134
    - Magyar Honvédség Egészségügyi Központ
  - Debrecen, Hungary, 4032
    - Debreceni Egyetem, Klinikai Központ, Onkológiai Klinika
  - Gyula, Hungary, 5700
    - Békés Megyei Pándy Kálmán Kórház
  - Győr, Hungary, 9024
    - Petz Aladar Megyei Oktato Korhaz
  - Kecskemét, Hungary, 6000
    - Bács-Kiskun Vármegyei Oktatókórház
  - Szeged, Hungary, 6701
    - Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
Ireland
- - Cork, Ireland
    - Cork Uni Hospital
  - Dublin, Ireland, 8
    - St. James Hospital
  - Dublin, Ireland, 9
    - Beaumont Hospital
  - Dublin, Ireland, 7
    - Mater Misericordiae Uni Hospital
  - Dublin, Ireland
    - St Vincent'S Uni Hospital
  - Galway, Ireland
    - Galway University Hospital
  - Limerick, Ireland
    - University Hospital Limerick - Oncology
Israel
- - Haifa, Israel, 3109601
    - Rambam Medical Center
  - Petah Tikva, Israel, 49100
    - Rabin MC
  - Ramat Gan, Israel, 52621
    - Chaim Sheba Medical Center
  - Rehovot, Israel, 76100
    - Kaplan Medical Center
  - Tel Aviv, Israel, 6423906
    - Sourasky / Ichilov Hospital
Italy
- Apulia
  - Brindisi, Apulia, Italy, 72100
    - Ospedale Antonio Perrino
- Calabria
  - Catanzaro, Calabria, Italy, 88100
    - Campus Universitario S.Venuta
- Campania
  - Avellino, Campania, Italy, 83100
    - AORN'S.G.Moscati
  - Napoli, Campania, Italy, 80131
    - IRCCS Istituto Nazionale Tumori Fondazione Pascale
  - Napoli, Campania, Italy, 80131
    - Ist. Uni Federico Ii
- Emilia-Romagna
  - Bologna, Emilia-Romagna, Italy, 40138
    - Azienda Ospedaliero-Universitaria S.Orsola-Malpighi
  - Carpi, Emilia-Romagna, Italy, 41012
    - Ospedale Ramazzini
  - Reggio Emilia, Emilia-Romagna, Italy, 42100
    - Arcispedale Santa Maria Nuova
- Friuli Venezia Giulia
  - Aviano, Friuli Venezia Giulia, Italy, 33081
    - Irccs Centro Di Riferimento Oncologico (CRO)
  - Udine, Friuli Venezia Giulia, Italy, 33100
    - Divisione Onc Med dell'Azienda
- Lazio
  - Viterbo, Lazio, Italy, 01100
    - Ospedale Belcolle di Viterbo
- Liguria
  - Genoa, Liguria, Italy, 16132
    - Az. Osp. Uni Ria San Martino
  - Genoa, Liguria, Italy, 16128
    - Ente Ospedaliero Ospedali Galliera
  - Genoa, Liguria, Italy, 16132
    - IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST)
- Lombardy
  - Brescia, Lombardy, Italy, 25123
    - ASST degli Spedali Civili di Brescia
  - Lecco, Lombardy, Italy, 23900
    - Asst Di Lecco
  - Legnago, Lombardy, Italy, 37045
    - Ospedale Mater Salutis
  - Milan, Lombardy, Italy, 20141
    - Irccs Istituto Europeo Di Oncologia (IEO)
  - Monza, Lombardy, Italy, 20052
    - Policlinico di Monza
  - Pavia, Lombardy, Italy, 27100
    - IRCCS Fondazione Maugeri
  - Rozzano, Lombardy, Italy, 20089
    - IRCCS Istituto Clinico Humanitas
  - Saronno, Lombardy, Italy, 21047
    - Az. Osp. Di Busto P.O. Di Saronno
- Piedmont
  - Candiolo, Piedmont, Italy, 10060
    - Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo
- The Marches
  - Fano, The Marches, Italy, 61032
    - Ospedale S. Croce Di Fano
- Trentino-Alto Adige
  - Bolzano, Trentino-Alto Adige, Italy, 39100
    - Ospedale di Bolzano
- Tuscany
  - Prato, Tuscany, Italy, 59100
    - Nuovo Ospedale di Prato S. Stefano - Azienda USL Toscana Centro
- Umbria
  - Perugia, Umbria, Italy, 06132
    - Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
  - Terni, Umbria, Italy, 05100
    - Azienda Ospedaliera S. Maria - Terni
Japan
- - Aichi, Japan, 464-8681
    - Aichi Cancer Center Hospital, Breast Oncology
  - Chiba, Japan, 260-8717
    - Chiba Cancer Center
  - Chiba, Japan, 277-8577
    - National Cancer Center Hospital East
  - Ehime, Japan, 791-0280
    - Natl Hosp Org Shikoku
  - Fukuoka, Japan, 811-1395
    - National Hospital Organization Kyushu Cancer Center
  - Gunma, Japan, 371-8511
    - Gunma University Hospital
  - Hiroshima, Japan, 730-8518
    - Hiroshima City Hiroshima Citizens Hospital
  - Kagoshima, Japan, 892-0833
    - Sagara Hospital
  - Kanagawa, Japan, 216-8511
    - St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery
  - Kanagawa, Japan, 259-1193
    - Tokai University Hospital, Breast Surgery
  - Kumamoto, Japan, 862-8655
    - Kumamoto Shinto General Hospital
  - Kyoto, Japan, 606-8507
    - Kyoto University Hospital
  - Niigata, Japan, 951-8566
    - Niigata Cancer Ctr Hospital
  - Numakunai, Japan, 028-3695
    - Iwate Med Univ School of Med
  - Osaka, Japan, 540-0006
    - National Hospital Organization Osaka National Hospital
  - Osaka, Japan, 541-8567
    - Osaka International Cancer institute
  - Saitama, Japan, 362-0806
    - Saitama Cancer Center, Breast Oncology
  - Saitama, Japan, 350-1298
    - Saitama Medical University International Medical Center
  - Shizuoka, Japan, 411-8777
    - Shizuoka Cancer Center
  - Shizuoka, Japan, 420-8527
    - Shizuoka General Hospital
  - Tochigi, Japan, 329-0498
    - Jichi Medical School
  - Tokyo, Japan, 104-0045
    - National Cancer Center Hospital
  - Tokyo, Japan, 113-8677
    - Tokyo Metropolitan
  - Tokyo, Japan, 135-8550
    - The Cancer Inst. Hosp. of JFCR
  - Tokyo, Japan, 160-0023
    - Tokyo Medical Uni. Hospital
Mexico
- - Aguascalientes, Mexico, 20230
    - Médicos Especialistas en Cáncer SC
  - Durango, Mexico, 34000
    - Centro Estatal De Cancerologia De Durango
  - Querétaro, Mexico, 76178
    - Cancerologia de Queretaro
- Campeche
  - Campehe, Campeche, Mexico, 24096
    - Centro Estatal de Oncología de Campeche
- Guanajuato
  - León, Guanajuato, Mexico, 37000
    - Fundacion Rodolfo Padilla Padilla A.C.
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44670
    - Núcleo de Especialidades Oncológicas
- Mexico CITY (federal District)
  - Mexico City, Mexico CITY (federal District), Mexico, 06726
    - Hospital General de Mexico
  - Mexico City, Mexico CITY (federal District), Mexico, 06760
    - Hospital Angeles Metropolitano
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64020
    - Centro Universitario Contra El Cancer
  - Montrrey, Nuevo León, Mexico, 64710
    - Centro de Diagnóstico y Tratamiento Integral de Mama, Hospital San José Tec de Monterrey
- Oaxaca
  - Oaxaca City, Oaxaca, Mexico, 68000
    - Oaxaca Site Management Organization
Netherlands
- - Alkmaar, Netherlands, 1815 JD
    - Medisch Centrum Alkmaar
  - Breda, Netherlands, 4819 EV
    - Amphia ziekenhuis, locatie langendijk
  - Delft, Netherlands, 2625 AD
    - Reinier de Graaf Gasthuis
  - Maastricht, Netherlands, 6229 HX
    - Academish Ziekenhuis Maastricht (Azm)
  - Zwolle, Netherlands, 8011 JW
    - Isala Klinieken
New Zealand
- - Hamilton, New Zealand, 3240
    - Waikato Hospital
  - Palmerston North, New Zealand, 4442
    - Palmerston North Hospital
Panama
- - Panama City, Panama, 32400
    - The Panama Clinic
  - Panama City, Panama, 0834-02723
    - Centro Oncologico America
Peru
- - Lima, Peru, 34
    - Instituto Nacional de Enfermedades Neoplasicas
  - Lima, Peru, L27
    - Clinica Anglo Americana - Centro de Investigacion Oncologia CAA
  - San Isidro, Peru, L27 Lima
    - Clinica El Golf
  - Trujillo, Peru, 13011
    - Clinica Peruana Americana
Philippines
- - Manila, Philippines, 1008
    - University of Santo Tomas
  - Pasig, Philippines, 1605
    - Rizal Medical Center
  - Quezon City, Luzon, Philippines, 1101
    - Veterans Memorial Medical Ctr
Poland
- - Bialystok, Poland, 15-027
    - Bialostockie Ctr Onkologii
  - Bydgoszcz, Poland, 85-796
    - Centrum Onkologii
  - Gda?sk, Poland, 80-214
    - Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
  - Opole, Poland, 45-060
    - Opolskie Centrum Onkologii
  - Warsaw, Poland, 02-781
    - Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad
  - Wieliszew, Poland, 05-135
    - NZOZ Mazowiecki Szpital Onkologiczny Uczelni Warszawskiej im. M. Sk?odowskiej-Curie
Romania
- - Bucharest, Romania, 050098
    - Emergency University Bucharest Hospital
  - Cluj-Napoca, Romania, 400015
    - Prof. Dr. I. Chiricuta Institute of Oncology
  - Cluj-Napoca, Romania, 400015
    - Oncology Inst. Cluj-Napoca
  - Iași, Romania, 700106
    - Euroclinic Center of Oncology SRL
Russia
- - Samara, Russia, 443031
    - SBI of Healthcare Samara Regional Clinical Oncology Dispensary
  - Stavropol, Russia, 355045
    - SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
  - Tula, Russia, 300053
    - Tula Regional Oncology Dispensary
- Moscow Oblast
  - Moscow, Moscow Oblast, Russia, 115478
    - S.I. Russian Oncological Research Center n.a. N.N. Blokhin
- Stavropol Kray
  - Pyatigorsk, Stavropol Kray, Russia, 357502
    - State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary
- Tatarstan Republic
  - Kazan', Tatarstan Republic, Russia, 420029
    - Clinical Oncology Dispensary of Ministry of Health of Tatarstan
Slovenia
- - Ljubljana, Slovenia, 1000
    - Institute of Oncology Ljubljana
South Africa
- - Bloemfontein, South Africa, 9301
    - National Hospital
  - Johannesburg, South Africa, 2193
    - Wits Donald Gordon Clinical Trial Centre
  - Pretoria, South Africa, 0002
    - Steve Biko Academic Hospital
South Korea
- - Gyeonggi-do, South Korea, 13620
    - Seoul National University Bundang Hospital
  - Seoul, South Korea, 110-744
    - Seoul National Uni Hospital
  - Seoul, South Korea, 120-752
    - Yonsei University Severance Hospital
  - Seoul, South Korea, 130-702
    - Kyunghee University Hospital
  - Seoul, South Korea, 135-170
    - Samsung Medical Centre
  - Seoul, South Korea, 136-705
    - Korea University Anam Hospital
Spain
- - A Coruña, Spain, 15009
    - Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia
  - Barcelona, Spain, 08003
    - Hospital del Mar
  - Barcelona, Spain, 08036
    - Hospital Clinic I Provincial
  - Barcelona, Spain, 08041
    - Hospital de la Santa Creu i Sant Pau
  - Barcelona, Spain, 08916
    - Hospital Universitari Germans Trias I Pujol
  - Barcelona, Spain, 08908
    - Hospital Duran i Reynals
  - Barcelona, Spain, 08035
    - Vall d'Hebron Institute of Oncology (VHIO), Barcelona
  - Huelva, Spain, 21005
    - Hospital Juan Ramón Jimenez
  - Jaén, Spain, 23007
    - Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico
  - Madrid, Spain, 28041
    - Hospital Universitario 12 de Octubre
  - Madrid, Spain, 28034
    - Hospital Ramon y Cajal
  - Madrid, Spain, 28040
    - Hospital Universitario Clínico San Carlos
  - Madrid, Spain, 28050
    - Centro Integral Oncológico Clara Campal (CIOCC)
  - Madrid, Spain, 28033
    - Centro Oncologico MD Anderson Internacional
  - Madrid, Spain, 28041
    - Hospital General Universitario Gregorio Maranon
  - Murcia, Spain, 30008
    - Hospital General Universitario J.M Morales Meseguer
  - Salamanca, Spain, 37007
    - Hospital Clinico Universitario de Salamanca
  - Seville, Spain, 41013
    - Hospital Universitario Virgen del Rocio
  - Seville, Spain, 41009
    - Hospital Universitario Virgen Macarena
  - Seville, Spain, 41014
    - Hospital Univ. Nuestra Señora de Valme
  - Toledo, Spain, 45004
    - Complejo Hospitalario de Toledo- H. Virgen de la Salud
  - Valencia, Spain, 46010
    - Hospital Clinico Universitario de Valencia
  - Valencia, Spain, 46015
    - Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia
  - Valencia, Spain, 46026
    - Hospital Universitario La Fe
  - Valencia, Spain, 46009
    - Instituto Valenciano Oncologia
  - Zaragoza, Spain, 50009
    - Hospital Universitario Miguel Servet
- Alicante
  - Elche, Alicante, Spain, 03202
    - Hospital General Universitario de Elche
- Balearic Islands
  - Palma de Mallorca, Balearic Islands, Spain, 07198
    - Hospital Son Llatzer
  - Palma de Mallorca, Balearic Islands, Spain, 07014
    - Hospital Universitario Son Espases
- Barcelona
  - Sabadell, Barcelona, Barcelona, Spain, 08208
    - Corporacio Sanitaria Parc Tauli
- Cantabria
  - Santander, Cantabria, Spain, 39008
    - Hospital Universitario Marques de Valdecilla
- Castellon
  - Castellon, Castellon, Spain, 12002
    - Hospital Provincial de Castellon
- Cordoba
  - Córdoba, Cordoba, Spain, 14004
    - Hospital Universitario Reina Sofía
- Guipuzcoa
  - Donostia / San Sebastian, Guipuzcoa, Spain, 20080
    - Hospital de Donostia
  - Donostia / San Sebastian, Guipuzcoa, Spain, 20014
    - IInstituto Oncologico de San Sebastian, Oncologikoa
- LA Coruna
  - A Coruña, LA Coruna, Spain, 15006
    - Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
  - Santiago de Compostela, LA Coruna, Spain, 15706
    - Complejo Hospitalario Universitario de Santiago (CHUS)
- Lerida
  - Lleida, Lerida, Spain, 25198
    - Hospital Universitari Arnau de Vilanova de Lleida
- Malaga
  - Málaga, Malaga, Spain, 29010
    - Hospital Clinico Universitario Virgen de la Victoria
- Tenerife
  - San Cristóbal de La Laguna, Tenerife, Spain, 38320
    - Hospital Universitario de Canarias
Sweden
- - Gothenburg, Sweden, 40036
    - Sahlgrenska Universitetssjukhuset
  - Linköping, Sweden, 58185
    - Uni Hospital Linkoeping
  - Stockholm, Sweden, S-118 83
    - Karolinska University Hospital
  - Umeå, Sweden, 90185
    - Norrlands Universitetssjukhus, Umeå, Cancercentrum
  - Uppsala, Sweden, 75185
    - Akademiska sjukhuset, Onkologkliniken
Switzerland
- - Basel, Switzerland, 4031
    - Universitaetsspital Basel
  - Geneva, Switzerland, 1211
    - Hôpitaux Universit. de Genève Gynécologique - Oncologie
  - Lucerne, Switzerland, 6004
    - Luzerner Kantonsspital
  - Sankt Gallen, Switzerland, 9007
    - Kantonsspital St. Gallen
  - Zurich, Switzerland, 8008
    - Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich
Taiwan
- - Changhua, Taiwan, 500
    - Changhua Christian Hospital
  - Kaohsiung City, Taiwan, 807
    - Kaohsiung Medical Uni Chung-Ho Hospital
  - Taichung, Taiwan, 407
    - Taichung Veterans General Hospital
  - Tainan, Taiwan, 704
    - National Cheng Kung Uni Hospital
  - Taipei, Taiwan, 114
    - Tri-Service General Hospital, Division of General Surgery
  - Taipei, Taiwan, 100
    - National Taiwan Uni Hospital
  - Taipei, Taiwan, 00112
    - Veterans General Hospital
Thailand
- - Chiang Rai, Thailand, 57000
    - Chiang Rai Prachanukraw Hospital
  - Lopburi, Thailand, 15000
    - Lopburi Cancer Hospital
  - Phitsanulok, Thailand, 65000
    - Buddhachinaraj Phitsanulok Hospital
  - Songkhla, Thailand, 90110
    - Songklanagarind Hospital
  - Surat Thani, Thailand, 84000
    - Surat Thani Hospital
Ukraine
- - Cherkassy, Ukraine, 18009
    - Cherkassy Regional Oncological Hospital
  - Dnipropetrovsk, Ukraine, 43102
    - State Medical Academy
  - Ivano-Frankivsk, Ukraine, 76018
    - Ivano-Frankivsk Regional Oncology Center
  - Kiev, Ukraine, 03115
    - Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients
  - Lutsk, Ukraine, 43018
    - Volyn Regional Oncology Dispensary
  - Lviv, Ukraine, 79031
    - Lvov State Regional Oncology Medical & Diagnostic Center
  - Ternopil, Ukraine, 46023
    - Ternopil State Medical Academy
United Kingdom
- - Berkshire, United Kingdom, RG1 5AN
    - Royal Berkshire Hospital
  - Cardiff, United Kingdom, CF14 2TL
    - Velindre Cancer Centre
  - Cheltenham, United Kingdom, GL53 7AN
    - Cheltenham General Hospital
  - Colchester, Essex, United Kingdom, CO4 5JL
    - Colchester General Hospital
  - Coventry, United Kingdom, CV2 2DX
    - University Hospital Coventry
  - Edinburgh, United Kingdom, EH4 2XU
    - Western General Hospital
  - Exeter, United Kingdom, EX2 5DW
    - Royal Devon & Exeter Hospital
  - Ipswich, United Kingdom, IP4 5PD
    - Ipswich Hospital
  - Leeds, United Kingdom, LS9 7TF
    - St James Uni Hospital
  - London, United Kingdom, SW3 6JJ
    - Royal Marsden Hospital
  - London, United Kingdom, EC1A 7BE
    - St. Bartholomew's Hospital
  - London, United Kingdom, NW1 2PG
    - UCL Hospital NHS Trust
  - Manchester, United Kingdom, M20 4BX
    - Christie Hospital
  - Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
    - The Clatterbridge Cancer Ctr For Oncolgy
  - Northwood, United Kingdom, HA6 2RN
    - Mount Vernon Hospital
  - Nottingham, United Kingdom, NG5 1PB
    - Nottingham City Hospital
  - Oxford, United Kingdom, OX3 7LJ
    - Churchill Hospital
  - Peterborough, United Kingdom, PE3 9GZ
    - Peterborough City Hospital, Edith Cavell Campus
  - Portsmouth, United Kingdom, PO6 3LY
    - Queen Alexandra Hospital
  - Preston, United Kingdom, PR2 9HT
    - Royal Preston Hosp
  - Sheffield, United Kingdom, S10 2SJ
    - Weston Park Hospital
  - Stoke-on-Trent, United Kingdom, ST4 6QG
    - Uni Hospital of North Staffordshire
  - Sutton, United Kingdom, SM2 5PT
    - Royal Marsden Hosp NHS Fnd
  - Truro, United Kingdom, TR1 3LJ
    - Royal Cornwall Hospital
  - Wolverhampton, United Kingdom, WV10 0QP
    - New Cross Hospital
United States
- Arizona
  - Scottsdale, Arizona, United States, 85258
    - HonorHealth Research Institute ? Bisgrove
- California
  - Everett, California, United States, 98208
    - Providence Regional Medical Center
  - Greenbrae, California, United States, 94904
    - Marin Cancer Care Inc
  - Hayward, California, United States, 94545
    - Kaiser Permanente - Hayward
  - La Jolla, California, United States, 92093
    - UCSD Moores Cancer Center
  - Los Angeles, California, United States, 90048
    - Cedars-Sinai Medical Center
  - Oakland, California, United States, 94611
    - Kaiser Permanente - Oakland
  - Roseville, California, United States, 95661
    - Kaiser Permanente - Roseville
  - Sacramento, California, United States, 95816
    - Sutter Cancer center
  - Sacramento, California, United States, 95825
    - Kaiser Permanente Sacramento Medical Center
  - San Diego, California, United States, 92108
    - Southern California Kaiser Permanente
  - San Francisco, California, United States, 94115
    - K. Permanente - San Fransisco
  - San Jose, California, United States, 95119
    - K. Permanente - San Jose
  - Santa Clara, California, United States, 95051
    - K. Permanente - Santa Clara
  - South San Francisco, California, United States, 94080
    - K. Permanente - S. San Fran
  - Vallejo, California, United States, 94589
    - Kaiser Permanente
  - Walnut Creek, California, United States, 94596
    - K. Permanente - Walnut Creek
- Colorado
  - Denver, Colorado, United States, 80220
    - Rocky Mountain Cancer Center - Denver
  - Wheat Ridge, Colorado, United States, 80033
    - Lutheran Hematology &Oncology
- Connecticut
  - Norwich, Connecticut, United States, 06360
    - Eastern Ct Hema/Onco Assoc
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20010
    - Washington Cancer Institute at MedStar Washington Hospital Center.
  - Washington D.C., District of Columbia, United States, 20057
    - Georgetown U
- Florida
  - Fort Myers, Florida, United States, 33916
    - Florida Cancer Specialists
  - Hollywood, Florida, United States, 33021
    - Memorial Cancer Institute
  - Jacksonville, Florida, United States, 32224
    - Mayo Clinic-Jacksonville
  - Jacksonville, Florida, United States, 32256
    - Cancer Specialists
  - Ocala, Florida, United States, 34474
    - Ocala Oncology Center
  - Pembroke Pines, Florida, United States, 33028
    - Memorial Breast Cancer Center
  - Port Saint Lucie, Florida, United States, 34952
    - Hematology Oncology Associates of the Treasure Coast
  - St. Petersburg, Florida, United States, 33705
    - Florida Cancer Specialists
  - West Palm Beach, Florida, United States, 33401
    - Florida Cancer Specialists, Research Department
- Georgia
  - Albany, Georgia, United States, 31701
    - Phoebe Putney Memorial Hospital
  - Atlanta, Georgia, United States, 30341
    - Georgia Cancer Specialists
  - Marietta, Georgia, United States, 30060
    - Northwest Georgia Oncology Centers PC - Marietta
- Idaho
  - Post Falls, Idaho, United States, 83854
    - Kootenai Cancer Center
- Illinois
  - Chicago, Illinois, United States, 60612
    - Rush University Medical Center
  - Chicago, Illinois, United States, 60637
    - Uni of Chicago
  - Harvey, Illinois, United States, 60426
    - Ingalls Memorial Hospital
  - Maywood, Illinois, United States, 60153
    - Loyola University Med Center
  - Naperville, Illinois, United States, 60540
    - Edward Cancer Center Naperville
  - Peoria, Illinois, United States, 61615-7828
    - Illinois Cancer Care
  - Plainfield, Illinois, United States, 60585
    - Edward Cancer Center Plainfield
  - Quincy, Illinois, United States, 62301
    - Quincy Medical Group
  - Urbana, Illinois, United States, 61801
    - Carle Foundation
- Iowa
  - Iowa City, Iowa, United States, 52242
    - University of Iowa
- Kansas
  - Wichita, Kansas, United States, 67214-3728
    - Cancer Center of Kansas
- Louisiana
  - Lafayette, Louisiana, United States, 70503
    - Cancer Center of Acadiana at Lafayette General
- Maine
  - Bangor, Maine, United States, 04401
    - Cancer Care of Maine
  - Scarborough, Maine, United States, 04074
    - New England Cancer Specialists
- Maryland
  - Baltimore, Maryland, United States, 21202
    - Mercy Medical Center
  - Baltimore, Maryland, United States, 21237
    - Weinberg CA Inst Franklin Sq
  - Bethesda, Maryland, United States, 20817
    - Maryland Oncology & Hematology, PA
- Massachusetts
  - Boston, Massachusetts, United States, 02118
    - Boston Medical Center
  - Boston, Massachusetts, United States, 02215
    - Dana Farber Can Ins
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital.
  - Boston, Massachusetts, United States, 02215
    - Beth Israel Deac Med Ctr
  - Pittsfield, Massachusetts, United States, 01201
    - Berkshire Hematology, Oncology Pc
- Michigan
  - Grand Rapids, Michigan, United States, 49503
    - Grand Rapids Clinical Oncology Program
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
- Minnesota
  - Edina, Minnesota, United States, 55414
    - Southdale Cancer Clinic
  - Saint Cloud, Minnesota, United States, 56303
    - Coborn Cancer Center
  - Saint Louis Park, Minnesota, United States, 55416
    - Metro-Minnesota Community Oncology Research Consortium
- Mississippi
  - Jackson, Mississippi, United States, 39202
    - Jackson Oncology Associates, PLLC
- Missouri
  - St Louis, Missouri, United States, 63110
    - Washington University School of Medicine
  - St Louis, Missouri, United States, 63131
    - Heartland CCOP/Missouri Baptist Medical Center
- Nebraska
  - Lincoln, Nebraska, United States, 68510
    - Cancer Alliance of Nebraska
  - Omaha, Nebraska, United States, 68106
    - Cancer Alliance of Nebraska
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - Dartmouth Hitchcock Med Center
- New Jersey
  - Livingston, New Jersey, United States, 07039
    - Saint Barnabas Medical Center
- New York
  - Albany, New York, United States, 12206
    - New York Oncology Hematology, P.C.
  - Buffalo, New York, United States, 14263
    - Roswell Park Cancer Inst.
  - New York, New York, United States, 10065
    - Memorial Sloan Kettering Cancer Center
  - New York, New York, United States, 10019
    - Mount Sinai West
  - New York, New York, United States, 10011
    - Mount Sinai Beth Israel Comprehensive Cancer Center
  - New York, New York, United States, 10003
    - Mount Sinai Beth Israel Medical Center
  - Syracuse, New York, United States, 13210
    - Suny Upstate Medical University
  - The Bronx, New York, United States, 10467
    - Montefiore Medical Center
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599
    - University of North Carolina-Chapel Hill
  - Hickory, North Carolina, United States, 28602
    - Carolina Oncology Specialists, PA - Hickory
- Ohio
  - Cincinnati, Ohio, United States, 45242
    - Oncology Hematology Care Inc
  - Columbus, Ohio, United States, 43219
    - The Mark H. Zangmeister Ctr
  - Dayton, Ohio, United States, 45420
    - Dayton Clinical Oncology Prog
  - Toledo, Ohio, United States, 43623-3536
    - Toledo Clinic Cancer Center
- Oregon
  - Portland, Oregon, United States, 97213
    - Northwest Cancer Specialists - Portland (NE Hoyt St)
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104
    - Abramson Cancer Center
  - Philadelphia, Pennsylvania, United States, 19141
    - Albert Einstein Healthcare Network
  - Pittsburgh, Pennsylvania, United States, 15213
    - Magee Womens Hospital
- South Carolina
  - Charleston, South Carolina, United States, 29414
    - Charleston Oncology, P .A
  - Charleston, South Carolina, United States, 29414
    - Roper Bon Secours St. Francis Cancer Center
  - Columbia, South Carolina, United States, 29210
    - South Carolina Oncology Associates - SCRI
  - Columbia, South Carolina, United States, 65203
    - University of Missouri-Columbia
  - Greenville, South Carolina, United States, 29615
    - Cancer Centers of the Carolina
- South Dakota
  - Sioux Falls, South Dakota, United States, 57104
    - Sanford USD School of Medicine
- Tennessee
  - Chattanooga, Tennessee, United States, 37403
    - Tennessee Oncology , PLLC - Chattanooga
  - Nashville, Tennessee, United States, 37203
    - Tennessee Oncology - Nashville
  - Nashville, Tennessee, United States, 37204
    - Vanderbilt Breast Center at One Hundred Oaks
- Texas
  - Dallas, Texas, United States, 75230
    - Texas Oncology-Medical City Dallas
  - Dallas, Texas, United States, 75246
    - Texas Oncology - DFW
  - Dallas, Texas, United States, 75231
    - Texas Oncology - DFW at Dallas Presbyterian Hospital
  - El Paso, Texas, United States, 79902
    - Texas Oncology-El Paso Cancer Treatment Center Grandview
  - Fort Worth, Texas, United States, 76104
    - The Center for Cancer and Blood Disorders - Fort Worth
  - Fort Worth, Texas, United States, 76104
    - Texas Oncology - DFW Fort Worth
  - Garland, Texas, United States, 77060
    - Texas Oncology, P.A. - Garland
  - Houston, Texas, United States, 77024
    - Texas Oncology - Houston (Gessner)
  - New Braunfels, Texas, United States, 78130
    - Cancer Care Centers of South Texas-HOAST - San Antonio
  - Plano, Texas, United States, 75075
    - Texas Oncology - DFW Plano
  - Tyler, Texas, United States, 75702
    - Texas Oncology-Tyler
- Utah
  - Ogden, Utah, United States, 84405
    - Community Cancer Trials of Utah
- Virginia
  - Bristol, Virginia, United States, 24201
    - Wellmonth Physician Services
  - Richmond, Virginia, United States, 23230
    - Virginia Cancer Institute
- Washington
  - Walla Walla, Washington, United States, 99362
    - Providence St. Mary Regional Cancer Center
- West Virginia
  - Morgantown, West Virginia, United States, 26506-9162
    - West Virginia University Hospitals Inc
- Wisconsin
  - Green Bay, Wisconsin, United States, 54301
    - Green Bay Oncology/St. Mary?s Hospital
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Clinic

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Non-metastatic operable primary invasive HER2-positive carcinoma of the breast that is histologically confirmed, and adequately excised
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (</=) 1
Known hormone receptor status (estrogen receptor and progesterone receptor)
The interval between definitive surgery for breast cancer and the first dose of chemotherapy must be no more than 8 weeks (56 days). The first cycle of chemotherapy must be administered within 7 days of randomization or on Day 56, whichever occurs first
Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 55 percent (%) measured by echocardiogram (ECHO) or Multiple-Gated Acquisition (MUGA) Scan
Confirmed HER2 positive status
Completion of all necessary baseline laboratory and radiologic investigations prior to randomization
Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the participant and/or partner for the duration of the study treatment and for at least 7 months after the last dose of study drug

Exclusion Criteria:

History of any prior (ipsi- and/or contralateral) invasive breast cancer
History of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin
Any "clinical" T4 tumor as defined by primary tumor/regional lymph nodes/distant metastasis (TNM), including inflammatory breast cancer
Any node-negative tumor
Any previous systemic chemotherapy for cancer or radiotherapy for cancer
Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer
Concurrent anti-cancer treatment in another investigational trial
Serious cardiac or cardiovascular disease or condition
Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness
Abnormal laboratory tests immediately prior to randomization
Pregnant or lactating women
Sensitivity to any of the study medications or any of the ingredients or excipients of these medications

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: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pertuzumab + Trastuzumab + Chemotherapy Participants will receive pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) intravenously (IV) every 3 weeks (Q3W) for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 once weekly (QW); 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	Drug: Doxorubicin Doxorubicin will be administered as per the schedule specified in the respective arm. Drug: Cyclophosphamide Cyclophosphamide will be administered as per the schedule specified in the respective arm. Drug: Paclitaxel Paclitaxel will be administered as per the schedule specified in the respective arm. Drug: Trastuzumab Trastuzumab will be administered as per the schedule specified in the respective arm. Other Names: Herceptin® Drug: Pertuzumab Pertuzumab will be administered as per the schedule specified in the respective arm. Other Names: Perjeta® Drug: 5-Fluorouracil 5-Fluorouracil will be administered as per the schedule specified in the respective arm. Drug: Carboplatin Carboplatin will be administered as per the schedule specified in the respective arm. Drug: Docetaxel Docetaxel will be administered as per the schedule specified in the respective arm. Drug: Epirubicin Epirubicin will be administered as per the schedule specified in the respective arm.
Placebo Comparator: Placebo + Trastuzumab + Chemotherapy Participants will receive placebo matching to pertuzumab IV Q3W and trastuzumab (8 milligrams per kilogram [mg/kg] loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 milligrams per square meter (mg/m^2) + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 milligrams [mg]).	Drug: Doxorubicin Doxorubicin will be administered as per the schedule specified in the respective arm. Drug: Cyclophosphamide Cyclophosphamide will be administered as per the schedule specified in the respective arm. Drug: Paclitaxel Paclitaxel will be administered as per the schedule specified in the respective arm. Drug: Trastuzumab Trastuzumab will be administered as per the schedule specified in the respective arm. Other Names: Herceptin® Drug: Placebo Placebo will be administered as per the schedule specified in the respective arm. Drug: 5-Fluorouracil 5-Fluorouracil will be administered as per the schedule specified in the respective arm. Drug: Carboplatin Carboplatin will be administered as per the schedule specified in the respective arm. Drug: Docetaxel Docetaxel will be administered as per the schedule specified in the respective arm. Drug: Epirubicin Epirubicin will be administered as per the schedule specified in the respective arm.

Participant Group / Arm

Intervention / Treatment

Experimental: Pertuzumab + Trastuzumab + Chemotherapy

Participants will receive pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) intravenously (IV) every 3 weeks (Q3W) for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m^2 + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 once weekly (QW); 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).

Drug: Doxorubicin

Doxorubicin will be administered as per the schedule specified in the respective arm.

Drug: Cyclophosphamide

Cyclophosphamide will be administered as per the schedule specified in the respective arm.

Drug: Paclitaxel

Paclitaxel will be administered as per the schedule specified in the respective arm.

Drug: Trastuzumab

Trastuzumab will be administered as per the schedule specified in the respective arm.

Other Names:

Herceptin®

Drug: Pertuzumab

Pertuzumab will be administered as per the schedule specified in the respective arm.

Other Names:

Perjeta®

Drug: 5-Fluorouracil

5-Fluorouracil will be administered as per the schedule specified in the respective arm.

Drug: Carboplatin

Carboplatin will be administered as per the schedule specified in the respective arm.

Drug: Docetaxel

Docetaxel will be administered as per the schedule specified in the respective arm.

Drug: Epirubicin

Epirubicin will be administered as per the schedule specified in the respective arm.

Placebo Comparator: Placebo + Trastuzumab + Chemotherapy

Participants will receive placebo matching to pertuzumab IV Q3W and trastuzumab (8 milligrams per kilogram [mg/kg] loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 milligrams per square meter (mg/m^2) + epirubicin 90-120 mg/m^2 or doxorubicin 50 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m^2 for 3 cycles, 75 mg/m^2 in first cycle and 100 mg/m^2 in subsequent cycles, or 75 mg/m^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m^2 or epirubicin 90-120 mg/m^2 + cyclophosphamide 500-600 mg/m^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m^2 + carboplatin AUC 6 (up to 900 milligrams [mg]).

Drug: Doxorubicin

Doxorubicin will be administered as per the schedule specified in the respective arm.

Drug: Cyclophosphamide

Cyclophosphamide will be administered as per the schedule specified in the respective arm.

Drug: Paclitaxel

Paclitaxel will be administered as per the schedule specified in the respective arm.

Drug: Trastuzumab

Trastuzumab will be administered as per the schedule specified in the respective arm.

Other Names:

Herceptin®

Drug: Placebo

Placebo will be administered as per the schedule specified in the respective arm.

Drug: 5-Fluorouracil

5-Fluorouracil will be administered as per the schedule specified in the respective arm.

Drug: Carboplatin

Carboplatin will be administered as per the schedule specified in the respective arm.

Drug: Docetaxel

Docetaxel will be administered as per the schedule specified in the respective arm.

Drug: Epirubicin

Epirubicin will be administered as per the schedule specified in the respective arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings Time Frame: Randomization to the first occurrence of IDFS event (excluding SPNBC) (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)	Percentage of participants with IDFS events (excluding SPNBC) is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (that is [i.e.], an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including ductal carcinoma in situ [DCIS] and lobular carcinoma in situ [LCIS]) and non-melanoma skin cancer were excluded as an event.	Randomization to the first occurrence of IDFS event (excluding SPNBC) (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings Time Frame: 3 years	Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (excluding SPNBC) at 3 years is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event.	3 years

Secondary Outcome Measures

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

Collaborators

Genentech, Inc.

Breast International Group

Investigators

Study Director: Clinical Trials, 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

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)

November 8, 2011

Primary Completion (Actual)

December 19, 2016

Study Completion (Actual)

November 28, 2024

Study Registration Dates

First Submitted

May 20, 2011

First Submitted That Met QC Criteria

May 20, 2011

First Posted (Estimated)

May 24, 2011

Study Record Updates

Last Update Posted (Estimated)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

BO25126
TOC4939G (Other Identifier: Genentech)
2010-022902-41 (EudraCT Number)
BIG 4-11 (Other Identifier: Breast International Group)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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.

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Outcome Measure	Measure Description	Time Frame
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score Time Frame: Baseline, Weeks 13, 25; end of treatment (EOT, 28 days after the last dose, up to Week 56); Follow-up (FU) Months 18, 24, 36	EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better GHS/QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.	Baseline, Weeks 13, 25; end of treatment (EOT, 28 days after the last dose, up to Week 56); Follow-up (FU) Months 18, 24, 36
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36	EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 functioning scores were linearly transformed on a scale of 0 to 100, with a high score indicating better functioning/support. Negative change from Baseline values indicated deterioration in functioning and positive values indicated improvement.	Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36	EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 disease/treatment-related symptom scores were linearly transformed on a scale of 0 to 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicated improvement in symptoms and positive values indicated worsening of symptoms.	Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36	EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 financial difficulties scores were linearly transformed on a scale of 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicated improvement in financial difficulties and positive values indicated worsening of financial difficulties.	Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36	EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.	Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36	EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for symptom scale indicated high level of symptomatology/problems/greater degree of symptoms. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.	Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36	EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in mobility domain was reported: I have no problems in walking about; I have some problems in walking about; and I am confined to bed. Response percentages may not add up to 100% due to data rounding.	Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36	EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in self-care domain was reported: I have no problems with self-care; I have some problems washing or dressing myself; and I am unable to wash or dress myself. Response percentages may not add up to 100% due to data rounding.	Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36	EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in usual activities domain was reported: I have no problems with performing my usual activities; I have some problems with performing my usual activities; and I am unable to perform my usual activities. Response percentages may not add up to 100% due to data rounding.	Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36	EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in pain/discomfort domain was reported: I have no pain or discomfort; I have moderate pain or discomfort; and I have extreme pain or discomfort. Response percentages may not add up to 100% due to data rounding.	Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain Time Frame: Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36	EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in anxiety/depression domain was reported: I am not anxious or depressed; I am moderately anxious or depressed; and I am extremely anxious or depressed. Response percentages may not add up to 100% due to data rounding.	Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36
Trough Serum Concentration (Cmin) of Pertuzumab Time Frame: Cycles 1, 10 and 15 (Cycle length=21 days)		Cycles 1, 10 and 15 (Cycle length=21 days)
Cmin of Trastuzumab Time Frame: Cycles 1, 10 and 15 (Cycle length=21 days)		Cycles 1, 10 and 15 (Cycle length=21 days)
Peak Serum Concentration (Cmax) of Pertuzumab Time Frame: Cycles 1, 10 and 15 (Cycle length=21 days)		Cycles 1, 10 and 15 (Cycle length=21 days)
Cmax of Trastuzumab Time Frame: Cycles 1, 10 and 15 (Cycle length=21 days)		Cycles 1, 10 and 15 (Cycle length=21 days)
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings Time Frame: 6, 8, and 10 years	The Kaplan-Meier estimates of the percentage of participants who were IDFS event-free (excluding SPNBC) at 6, 8, and 10 years are reported. IDFS event was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, or contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event. Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free.	6, 8, and 10 years
Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings Time Frame: Randomization to the first occurrence of IDFS event (including SPNBC) (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)	Percentage of participants with IDFS events (including SPNBC) is reported. IDFS-SPNBC event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).	Randomization to the first occurrence of IDFS event (including SPNBC) (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings Time Frame: 3 years	Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (including SPNBC) at 3 years is reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).	3 years
Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings Time Frame: 6, 8, and 10 years	Kaplan-Meier estimates of the percentage of participants who were IDFS event-free (including SPNBC) at 6, 8, and 10 years are reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, or SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site). Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free.	6, 8, and 10 years
Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings Time Frame: Randomization to the first occurrence of DFS event (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)	Percentage of participants with DFS event is reported. DFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.	Randomization to the first occurrence of DFS event (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings Time Frame: 3 years	Kaplan-Meier estimate of the percentage of participants who were DFS event-free at 3 years is reported. DFS was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.	3 years
Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings Time Frame: 6, 8, and 10 years	Kaplan-Meier estimates of the percentage of participants who were DFS event-free at 6, 8, and 10 years are reported. DFS was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, SPNBC, or contralateral or ipsilateral DCIS. Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free.	6, 8, and 10 years
Percentage of Participants Who Died, First Interim Overall Survival Analysis Time Frame: Randomization until death due to any cause (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)	Percentage of participants who died due to any cause is reported.	Randomization until death due to any cause (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
Percentage of Participants Who Died, Final Overall Survival Analysis Time Frame: Randomization until death due to any cause (median [range] follow-up: 11.3 [0-12.9] years)	Percentage of participants who died due to any cause is reported.	Randomization until death due to any cause (median [range] follow-up: 11.3 [0-12.9] years)
Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 3 Years Time Frame: 3 years	The Kaplan-Meier approach was used to estimate the percentage of participants who were alive at 3 years. Participants who were alive (including lost to follow-up) at the time of the analysis were censored at the date when they were last known to be alive.	3 years
Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 6, 8, and 10 Years Time Frame: 6, 8, and 10 years	The Kaplan-Meier approach was used to estimate the percentage of participants who were alive at 6, 8, and 10 years. Participants who were alive (including lost to follow-up) at the time of the analysis were censored at the date when they were last known to be alive.	6, 8, and 10 years
Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings Time Frame: Randomization until local, regional or distant breast cancer recurrence (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)	Percentage of participants with RFI event is reported. RFI event was defined as local, regional or distant breast cancer recurrence.	Randomization until local, regional or distant breast cancer recurrence (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings Time Frame: 3 years	Kaplan-Meier estimate of the percentage of participants who were RFI event-free at 3 years is reported. RFI event was defined as local, regional or distant breast cancer recurrence. Participants who had not had a recurrence event at the time of data analysis were censored at the date last known to be alive or at their date of death.	3 years
Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings Time Frame: 6, 8, and 10 years	Kaplan-Meier estimates of the percentage of participants who were RFI event-free at 6, 8, and 10 years are reported. RFI event was defined as local, regional or distant breast cancer recurrence. Participants who had not had a recurrence event at the time of data analysis were censored at the date last known to be alive or at their date of death.	6, 8, and 10 years
Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings Time Frame: Randomization until distant breast cancer recurrence (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)	Percentage of participants with DRFI event is reported. DRFI event was defined as distant breast cancer recurrence.	Randomization until distant breast cancer recurrence (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings Time Frame: 3 years	Kaplan-Meier estimate of the percentage of participants who were DRFI event-free at 3 years is reported. DRFI event was defined as distant breast cancer recurrence. Participants who had not had a distant recurrence event at the time of data analysis were censored at the date last known to be alive or at their date of death.	3 years
Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings Time Frame: 6, 8, and 10 years	Kaplan-Meier estimates of the percentage of participants who were DRFI event-free at 6, 8, and 10 years are reported. DRFI event was defined as distant breast cancer recurrence. Participants who had not had a distant recurrence event at the time of data analysis were censored at the date last known to be alive or at their date of death.	6, 8, and 10 years
Percentage of Participants With Primary Cardiac Event, Primary Analysis Time Frame: Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years)	Primary cardiac event was defined as either: Heart Failure (New York Heart Association [NYHA] Class III or IV) and a drop in left ventricular ejection fraction (LVEF) of at least 10 ejection fraction (EF) points from baseline and to below 50 percent (%); or cardiac death. Cardiac death was defined as either definite cardiac death: due to heart failure, myocardial infarction, or documented primary arrhythmia; or probable cardiac death: sudden unexpected death within 24 hours of a definite or probable cardiac event (e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology.	Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years)
Percentage of Participants With Primary Cardiac Event, Final Analysis Time Frame: Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years)	Primary cardiac event was defined as either: Heart Failure (New York Heart Association [NYHA] Class III or IV) and a drop in left ventricular ejection fraction (LVEF) of at least 10 ejection fraction (EF) points from baseline and to below 50 percent (%); or cardiac death. Cardiac death was defined as either definite cardiac death: due to heart failure, myocardial infarction, or documented primary arrhythmia; or probable cardiac death: sudden unexpected death within 24 hours of a definite or probable cardiac event (e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology.	Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years)
Percentage of Participants With Secondary Cardiac Event, Primary Analysis Time Frame: Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years)	Secondary cardiac event was defined as asymptomatic or mildly symptomatic (NYHA Class II) significant drop in LVEF (defined as an absolute decrease of at least 10 EF points from baseline and to below 50%), confirmed by a second LVEF assessment within approximately three weeks of the first significant LVEF assessment or confirmed by the Cardiac Advisory Board (CAB).	Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years)
Percentage of Participants With Secondary Cardiac Event, Final Analysis Time Frame: Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years)	Secondary cardiac event was defined as asymptomatic or mildly symptomatic (NYHA Class II) significant drop in LVEF (defined as an absolute decrease of at least 10 EF points from baseline and to below 50%), confirmed by a second LVEF assessment within approximately three weeks of the first significant LVEF assessment or confirmed by the Cardiac Advisory Board (CAB).	Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years)
Change From Baseline in LVEF to Worst Post-Baseline Value, Primary Analysis Time Frame: Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years)	LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. Baseline LVEF value and the maximum absolute decrease (worst value) in LVEF measurement from baseline were reported. LVEF was measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan.	Baseline until data cut-off date 19 December 2016 (median [range] follow-up: 3.8 [0.1-4.9] years)
Change From Baseline in LVEF to Worst Post-Baseline Value, Final Analysis Time Frame: Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years)	LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. Baseline LVEF value and the maximum absolute decrease (worst value) in LVEF measurement from baseline were reported. LVEF was measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan.	Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years)

A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer (APHINITY)

A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer

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