1,846
Participants
Start Date
January 31, 2014
Primary Completion Date
November 27, 2019
Study Completion Date
June 4, 2021
Trastuzumab Emtansine
Trastuzumab emtansine IV infusion (duration 90 minutes) will be administered at 3.6 mg/kg q3w for up to 18 cycles (1 cycle = 21 days).
Trastuzumab
Trastuzumab IV infusion (duration 90 minutes) will be administered at 8 mg/kg loading dose followed by 6 mg/kg IV q3w for up to 18 cycles (1 cycle = 21 days).
Pertuzumab
Pertuzumab infusion (duration 60 minutes) will be administered at 840 mg loading dose followed by 420 mg IV q3w for up to 18 cycles (1 cycle = 21 days).
Paclitaxel
IV infusion of paclitaxel 80 mg/m\^2 once weekly may be administered concurrently with trastuzumab in combination with pertuzumab for 12 weeks.
Epirubicin
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using epirubicin may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.
Doxorubicin
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using doxorubicin may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.
Docetaxel
IV infusion either docetaxel every 3 weeks (q3w) (at 100 milligram per square meter \[mg/m\^2\] for 3 cycles (1 cycle = 21 days); at 75 mg/m2 for 4 cycles; or start at 75 mg/m\^2 in the first cycle and escalate to 100 mg/m\^2 if no dose limiting toxicity occurs, for a total of 3 cycles at minimum) may be administered concurrently with trastuzumab in combination with pertuzumab.
Cyclophosphamide
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using cyclophosphamide (FEC) may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.
5-Fluorouracil
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using 5-fluorouracil, may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.
National Taiwan Uni Hospital; General Surgery, Taipei
Tri-Service General Hospital, Division of General Surgery, Taipei
Taichung Veterans General Hospital; Dept of Surgery, Taichung
Changhua Christian Hospital; Dept of Surgery, Changhua
Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery, Kaohsiung City
East Avenue Medical Center, Quezon City
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly, Budapest
Municipal Hospital of Uzsoki Utca; Centre of Oncoradiology, Budapest
San Juan de Dios Hospital;Oncology Unit, Pasay
Chris O'Brien Lifehouse, Camperdown
Calvary Mater Newcastle; Medical Oncology, Waratah
Sint Augustinus Wilrijk, Apotheek, Wilrijk
UZ Leuven Gasthuisberg, Leuven
Austin Hospital; Medical Oncology, Heidelberg
Epworth HealthCare; Clinical Trials Centre, Richmond
Frankston Hospital; Oncology/Haematology, Frankston
Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer, Stavanger
Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika, Debrecen
Haematology & Oncology Clinics of Australia Research Centre, South Brisbane
Burnside War Memorial Hospital, Clinical Trials Centre, Adelaide
Luzerner Kantonsspital; Medizinische Onkologie, Lucerne
St John of God Murdoch Hospital; Oncology West, Murdoch
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika, Szeged
Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie, Chur
Clinic of Oncology, University Clinical Center Sarajevo, Sarajevo
Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich, Zurich
Chulalongkorn Hospital; Medical Oncology, Bangkok
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology, Bangkok
ProHEALTH Care Associates LLP, Lake Success
Memorial Sloan-Kettering Cancer Center, Commack
Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios, Distrito Federal
Centre Francois Baclesse; Oncologie, Caen
Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche, Berlin
Magee-Woman's Hospital, Pittsburgh
Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher, Stralsund
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia, Rozzano
Ospedale San Raffaele, Milan
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1, Milan
Universitätsklinikum Hamburg-Eppendorf; Frauenklinik, Hamburg
ASST DI MONZA; Oncologia Medica, Monza
Centre Georges Francois Leclerc; Oncologie 3, Dijon
Mercy Medical Center, Baltimore
Anne Arundel Health System Research Instit-Annapolis Oncology Ctr, Annapolis
Centre Armoricain de Radiotherapie, de Imagerie Medicale et de Oncologie (CARIO), Plérin
University of Virginia Health System; Hematology/Oncology Division, Charlottesville
Virginia Commonwealth University - Massey Cancer Center, Richmond
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe, Lübeck
Blue Ridge Cancer Care - Salem, Salem
Wellmont Medical Associates, Bristol
HOPITAL JEAN MINJOZ; Oncologie, Besançon
ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit, Cremona
Agaplesion Diakonieklinikum Rotenburg, Rotenburg (Wümme)
Cone Health Cancer Center, Greensboro
Duke University Medical Center, Durham
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia, Madrid
Levine Cancer Institute, Charlotte
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia, Málaga
CHU de Brest - Hôpital de Morvan, Brest
Institut de cancerologie du Gard, Nîmes
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia, Murcia
Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding, Hanover
Georgia Cancer Specialists, Atlanta
University Cancer & Blood Center, LLC; Research, Athens
Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe, Hanover
Institut Claudius Regaud; Departement Oncologie Medicale, Toulouse
Central Georgia Cancer Care PC, Macon
Institut Bergonie; Oncologie, Bordeaux
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica, Aviano
Holy Cross Hospital, Fort Lauderdale
Florida Cancer Specialists; Saint Petersburg, St. Petersburg
Florida Cancer Specialists; SCRI, Fort Myers
Centre Eugene Marquis; Service d'oncologie, Rennes
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II, Padua
Fundacion Rodolfo Padilla Padilla A.C., León
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc, Nashville
SCRI Tennessee Oncology Chattanooga, Chattanooga
West Clinic, Germantown
Hospital Universitario de Canarias;servicio de Oncologia, San Cristóbal de La Laguna
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica, Bologna
Institut De Cancerologie De La Loire; Consult Oncologie Niveau 0, Saint-Priest-en-Jarez
State Medical Academy; Oncology, Dnipropetrovsk
Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel, Bochum
Ico Rene Gauducheau; Oncologie, Saint-Herblain
Oncology Hematology Care Inc, Cincinnati
Hospital Clínico Universitario de Valencia; Servicio de Oncología, Valencia
Indiana University, Indianapolis
Karmanos Cancer Institute.., Detroit
Henry Ford Hospital; Hematology Oncology, Detroit
Hospital de Cruces; Servicio de Oncologia, Bilbao
Ico - Paul Papin, Angers
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH, Georgsmarienhütte
Hospital Universitario Miguel Servet; Servicio Oncologia, Zaragoza
Praxis Dr.med. Katja Ziegler-Löhr, Cologne
Polyclinique De Courlancy; Centre Radiotherapie Oncologie, Reims
Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis, Troisdorf
Centre D'Oncologie de Gentilly; Oncology, Nancy
Centre Alexis Vautrin; Oncologie Medicale, Vandœuvre-lès-Nancy
US oncology research at Minnesota Oncology, Saint Paul
Chiang Rai Prachanukroh Hospital; Department Of Medicine, Chiang Rai
Centre Oscar Lambret; Cancerologie Gynecologique, Lille
Ospedale Misericordia E Dolce; Oncologia Medica, Prato
AGAPLESION Markus-Krankenhaus, Frankfurt
Hochwaldkrankenhaus, Bad Nauheim
Carle Cancer Center, Urbana
Quincy Medical Group; Canc Ctr at Blessing Hosp, Quincy
Centre Jean Perrin; Oncologie, Clermont-Ferrand
Hospital San Jose Del Tec. de Monterrey; Oncology, Monterrey
Buddhachinaraj Phitsanulok Hospital; Chemotherapy Unit ; Department of Medicine, Phitsanuok
Mercy Medical Research Institute, Springfield
Städtische Kliniken Frankfurt am Main Höchst, Frankfurt
Institut d'oncologie de l'Orangerie; Chimiotherapie, Strasbourg
Centre Paul Strauss; Oncologie Medicale, Strasbourg
Klinikum Worms; Frauenklinik; Klinik für Gynäkologie und Geburtshilfe, Worms
Centre Leon Berard; Departement Oncologie Medicale, Lyon
GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe, Weinheim
Clinique Victor Hugo; Chimiotherapie, Le Mans
Ospedale Antonio Perrino; Oncologia Medica, Brindisi
Mercy Clinic Oklahoma Communties, Inc, Oklahoma City
HOPITAL TENON; Cancerologie Medicale, Paris
The Center for Cancer and Blood Disorders - Fort Worth, Fort Worth
University Clinical Center of the Republic of Srpska, Banja Luka
Lviv State Oncological Regional Treatment and Diagnostic Center, Lviv
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR, Freiburg im Breisgau
Istituto Nazionale Tumori Fondazione G. Pascale, Napoli
Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde, München
Clinique Sainte Catherine, Avignon
HonorHealth Research Institute - Bisgrove, Scottsdale
Klinikum Augsburg, Augsburg
Hämatologisch/Onkologische Praxis Prof. Dr. Decker, Studienzentrum, Ravensburg
Dres.Jochen Wilke und Harald Wagner, Fürth
Southern California Kaiser Permanente, San Diego
Kaiser Permanente - South SF; Oncology Clinical trials, South San Francisco
Kaiser Permanente - San Leandro, San Leandro
Kaiser Permanente - Vallejo, Vallejo
Kaiser Permanente - Walnut Creek; Oncology Pharmacy, Walnut Creek
Kaiser Permanente - Oakland, Oakland
Humanitas Centro Catanese Di Oncologia; Oncologia Medica, Misterbianco (CT)
Kaiser Permanente - San Jose, San Jose
Klinikum Kulmbach; Frauenklinik, Kulmbach
Kaiser Permanente - Roseville; Oncology Pharmacy, Roseville
Kaiser Permanente - Sacramento; Oncology Pharmacy, Sacramento
UC Davis Cancer Center; Oncology, Sacramento
University of Washington, Seattle
Klinikum Meiningen Klinik f.Gynäkologie und Geburtshilfe, Meiningen
FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF, Moscow
National University Hospital; National University Cancer Institute, Singapore (NCIS), Singapore
Ivanovo Regional Oncology Dispensary, Ivanovo
National Cancer Centre; Medical Oncology, Singapore
Scientific Research Institute n.a. N.N. Petrov, Saint Petersburg
Oncomedica S.A., Montería
"SBI for HPE Ryazan State Medical University n.a. I.P. Pavlov of MoH of RF", Ryazan
Cluj Clinical County Hospital; Oncology Dept, Cluj-Napoca
Prof. Dr. I. Chiricuta Institute of Oncology, Cluj-Napoca
Republican Clinical Oncologic Dispensary of Republic Of Tatarstan, Kazan'
SBI of Healthcare Samara Regional Clinical Oncology Dispensary, Samara
State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis, Orenburg
Regional Institute of Oncology Iasi, Iași
ONCOCENTRO APYS; Oncología, Viña del Mar
Instituto Oncologico del sur, Temuco
Chaim Sheba Medical Center; Oncology Dept, Ramat Gan
Stanford University School of Medicine, Stanford
Cancer Center of Kansas, Wichita
Dana Farber Cancer Inst., Boston
Beth Israel Deaconess Med Ctr, Boston
Dartmouth Hitchcock Med Center, Lebanon
Rutgers Cancer Institute of New Jersey, New Brunswick
Thompson Cancer Survival Center, Knoxville
Hospital Araujo Jorge; Departamento de Ginecologia E Mama, Goiânia
Hospital Sao Lucas - PUCRS, Porto Alegre
Hospital Nossa Senhora da Conceicao, Porto Alegre
Hospital de Cancer de Barretos, Barretos
Instituto do Cancer do Estado de Sao Paulo - ICESP, São Paulo
Hospital Sirio Libanes; Centro de Oncologia, São Paulo
Hospital Perola Byington, São Paulo
Hospital Paulistano, São Paulo
Tom Baker Cancer Centre-Calgary, Calgary
BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre), Kelowna
Lions Gate Hospital, North Vancouver
BCCA-Vancouver Cancer Centre, Vancouver
Regional health authority A vitalite health network, Moncton
Queen Elizabeth II Health Sciences Centre; Oncology, Halifax
Kingston General Hospital, Kingston
London Regional Cancer Centre, London
Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre, Mississauga
Southlake Regional Health Center; Community Care Clinic / Oncology, Newmarket
Lakeridge Health Oshawa; Oncology, Oshawa
Sault Area Hospital, Sault Ste. Marie
North York General Hospital, Toronto
Princess Margaret Cancer Center, Toronto
Windsor Regional Cancer Centre, Windsor
Cite de La Sante de Laval; Hemato-Oncologie, Laval
McGill University; Glen Site; Oncology, Montreal
Hopital du Saint Sacrement, Québec
Masarykuv onkologicky ustav, Brno
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology, Hradec Králové
MULTISCAN, s.r.o., Radiologicke centrum Pardubice, Pardubice
Vseobecna fakultni nemocnice v Praze, Prague
Hospital Diagnostico Escalón, San Salvador
Centre Antoine Lacassagne, Nice
LTD Institute of Clinical Oncology, Tbilisi
Khechinashvili University Hospital ;Breast Unit, Tbilisi
Chemotherapy and Immunotherapy Clinic Medulla, Tbilisi
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie, Dresden
Centro Oncológico Sixtino / Centro Oncológico SA, Guatemala City
Grupo Angeles, Guatemala City
Princess Margaret Hospital; Oncology, Hong Kong
Tuen Mun Hospital; Clinical Oncology, Hong Kong
Queen Mary Hospital; Dept of Surgery, Pokfulam
Sourasky / Ichilov Hospital; Oncology Department, Tel Aviv
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica, Rome
Istituto Nazionale Tumori Regina Elena IRCCS, Rome
Azienda Ospedaliera S. Maria - Terni; Oncologia, Terni
Aichi Cancer Center Hospital, Breast Oncology, Aichi
Nagoya City University Hospital; Breast Surgery, Aichi
Natl Hosp Org Shikoku; Cancer Ctr, Surgery, Ehime
National Hospital Organization Kyushu Cancer Center;Breast Oncology, Fukuoka
Gunma University Hospital; Department of Breast and Endocrine Surgery, Gunma
Gunma Prefectural Cancer Center; Breast Oncology, Gunma
Hiroshima City Hiroshima Citizens Hospital; Breast Surgery, Hiroshima
Hiroshima University Hospital; Breast Surgery, Hiroshima
Hyogo College Of Medicine; Breast And Endocrine Surgery, Hyōgo
Sagara Hospital; Breast Surgery, Kagoshima
St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery, Kanagawa
Tokai University Hospital, Breast Surgery, Kanagawa
Kumamoto City Hospital, Breast and Endocrine Surgery, Kumamoto
Kumamoto Shinto General Hospital; Breast Cancer Center, Kumamoto
Kyoto University Hospital; Breast Surgery, Kyoto
Niigata Cancer Ctr Hospital; Breast Surgery, Niigata
Iwate Med Univ School of Med; Surgery, Numakunai
Kawasaki Medical School Hospital; Breast and Thyroid Surgery, Okayama
Naha-nishi Clinic; Surgery, Okinawa
National Hospital Organization Osaka National Hospital; Breast Surgery, Osaka
Osaka International Cancer Institute; Breast and Endocrine Surgery, Osaka
Saitama Medical University International Medical Center; Breast Oncology, Saitama
Saitama Cancer Center, Breast Oncology, Saitama
Shizuoka Cancer Center; Breast Surgery, Shizuoka
Shizuoka General Hospital; Breast Surgery, Shizuoka
Jichi Medical University; Breast Oncology, Tochigi
National Cancer Center Hospital; Medical Oncology, Tokyo
St. Luke's Internat. Hospital, Breast Surgical Oncology, Tokyo
Tokyo Metropolitan; Komagome Hospital, Surgery, Tokyo
The Cancer Inst. Hosp. of JFCR; Breast Oncology Center, Tokyo
Showa University Hospital; Breast Surgery, Tokyo
Tokyo Medical Uni. Hospital; Breast Oncology, Tokyo
Consultorio de Medicina Especializada; Dentro de Condominio San Francisco, Mexico City
Oslo universitetssykehus HF, Ullevål, Kreftsenteret, Oslo
Centro Hemato Oncologico Panama, Panama City
Clinica de Especialidades Medicas, Lima
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional, Lima
Clinica San Borja, Lima
Instituto Oncologico Miraflore, Miraflores
Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej, Bialystok
Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii, Bydgoszcz
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii, Gdansk
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii, Krakow
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii; Poradnia Chemioterapii, Lodz
Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii, Lublin
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii, Otwock
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr, Warsaw
Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti, Bucharest
National Cancer Center; Medical Oncology, Gyeonggi-do
Ajou Uni Hospital; Medical Oncology, Gyeonggi-do
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology, Seoul
Severance Hospital, Yonsei University Health System, Seoul
Samsung Medical Centre; Division of Hematology/Oncology, Seoul
Hospital del Mar; Servicio de Oncologia, Barcelona
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona
Hospital Duran i Reynals; Oncologia, Barcelona
Sahlgrenska Universitetssjukhuset; Jubileumskliniken, Gothenburg
Universitetssjukhuset Örebro, Onkologiska kliniken, Örebro
Akademiska sjukhuset, Onkologkliniken, Uppsala
VETERANS GENERAL HOSPITAL; Department of General Surgery, Taipei
Velindre Cancer Centre; Oncology Dept, Cardiff
Cheltenham General Hospital; Gloucestershire Oncology Centre, Cheltenham
Royal Cornwall Hospital; Dept of Clinical Oncology, Cornwall
University Hospital Coventry; InHANSE Unit and Clinical Trials Cancer Treatment Centre, Coventry
Western General Hospital; Edinburgh Breast Unit, Edinburgh
Royal Devon & Exeter Hospital; Oncology Centre, Exeter
Royal Surrey County Hospital; St. Lukes Cancer Centre, Guildford
Leicester Royal Infirmary; Dept. of Medical Oncology, Leicester
Royal Marsden Hospital - Fulham; Oncology Department, London
Charing Cross Hospital, London
Maidstone Hospital; Kent Oncology Centre, Maidstone
Christie Hospital; Breast Cancer Research Office, Manchester
Freeman Hospital; Northern Centre For Cancer Care, New Castle Upon Tyne
Mount Vernon Cancer Centre, Northwood
Nottingham City Hospital; Oncology, Nottingham
Peterborough City Hospital, Edith Cavell Campus; Oncology Department, Peterborough
Queen Alexandra Hospital; Portsmouth Haematology & Oncology Centre, Level B, Portsmouth
Weston Park Hospital; Cancer Clinical Trials Centre, Sheffield
Musgrove Park Hospital; Department Clinical Research, Beacon Centre, Somerset
Uni Hospital of North Staffordshire; Staffordshire Oncology Centre, Stoke-on-Trent
Royal Marsden Hospital; Dept of Medical Oncology, Sutton
Yeovil District Hospital; Macmillan Cancer Unit, Yeovil
Hoffmann-La Roche
INDUSTRY