500
Participants
Start Date
June 14, 2018
Primary Completion Date
July 4, 2019
Study Completion Date
June 2, 2023
Cyclophosphamide
Cyclophosphamide 600 mg/m2 will be administered IV on Day 1 of each cycle of treatment (as part of ddAC Q2W or AC Q3W) for Cycles 1-4.
Doxorubicin
Doxorubicin 60 mg/m2 will be administered IV on Day 1 of each cycle of treatment (as part of either ddAC Q2W or AC Q3W) for Cycles 1-4.
Docetaxel
As part of one of the two investigator's choices of chemotherapy (AC followed by docetaxel), docetaxel 75 mg/m2 will be administered IV on Day 1 of Cycle 5 and then 100 mg/m2 IV at the discretion of the investigator for Cycles 6-8 (Q3W), if no dose-limiting toxicity occurs.
Paclitaxel
As part of one of the two investigator's choices of chemotherapy (ddAC followed by paclitaxel), paclitaxel 80 mg/m2 will be administered IV QW for 12 weeks.
Pertuzumab IV
Pertuzumab will be administered as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose Q3W.
FDC of Pertuzumab and Trastuzumab SC
The FDC of pertuzumab and trastuzumab will be administered SC at a fixed non-weight-based dose. A loading dose of 1200 mg SC pertuzumab and 600 mg SC trastuzumab is then followed by a maintenance dose of 600 mg SC pertuzumab and 600 mg SC trastuzumab Q3W.
Trastuzumab IV
Trastuzumab will be administered as an 8-mg/kg IV loading dose and then 6 mg/kg IV maintenance dose Q3W.
Trastuzumab SC
After surgery (from Cycle 9 onwards), participants in Arm A will be allowed to switch from trastuzumab IV to trastuzumab SC, at the discretion of the investigator, in the countries where trastuzumab SC is routinely used. For participants who switch, a fixed dose of 600 mg trastuzumab SC (irrespective of the patient's weight) will be administered in the adjuvant phase.
Surgery
Participants in both cohorts are scheduled to undergo surgery after 8 cycles of neoadjuvant therapy. Participants may undergo breast-conserving surgery or mastectomy according to routine clinical practice.
Post-operative Radiotherapy
If indicated, radiotherapy is given after chemotherapy and surgery, during adjuvant HER2-targeted therapy and hormone therapy (for hormone-receptor positive disease).
Hormone Therapy
For hormone receptor positive breast cancer, tamoxifen or aromatase inhibitors will be allowed as adjuvant hormone therapy for postmenopausal participants and with ovarian suppression or ablation for premenopausal participants in countries where it has been registered for this indication. Its use must be consistent with the registered label. Hormone therapy is given after chemotherapy and surgery during adjuvant HER2-targeted therapy.
Chang Gung Medical Foundation - Linkou; Dept of Surgery, Taoyuan District
China Medical University Hospital; Surgery, Taichung
Institut Jules Bordet, Anderlecht
UZ Antwerpen, Edegem
UZ Leuven Gasthuisberg, Leuven
Jessa Zkh (Campus Virga Jesse), Hasselt
Clinique Ste-Elisabeth, Namur
GHdC Site Notre Dame, Charleroi
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology, Bangkok
Onkologische Schwerpunktpraxis Kurfürstendamm, Berlin
Hospital Universitario Reina Sofia; Servicio de Oncologia, Córdoba
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia, Santiago de Compostela
Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico, Genoa
Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher, Stralsund
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem, Hamburg
Maryland Oncology Hematology, Rockville
ASST DI LECCO; Oncologia Medica, Lecco
CHRU Besançon, Besançon
Hospital Universitario La Princesa, Madrid
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid
Levine Cancer Institute, Charlotte
Institut Bergonie; Oncologie, Bordeaux
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica, Aviano
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II, Padua
National Cancer Institute MOH of Ukraine, Kiev
RCI Sumy Regional Clinical Oncological Dispensary, Sumy
Hospital Universitario Virgen del Rocio; Servicio de Oncologia, Seville
Ulsan University Hosiptal, Ulsan
St. Johannes-Hospital, Dortmund
ICO - Site René Gauducheau, Saint-Herblain
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum, Essen
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia
Hospital de Cruces; Servicio de Oncología Médica, Barakaldo
ICO Paul Papin; Oncologie Medicale., Angers
Chemotherapy SI Dnipropetrovsk MA of MOHU, Dnipropetrovsk
Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial, Chiang Mai
Municipal Noncommercial Institution Regional Center of Oncology, Kharkiv
Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie, Bad Nauheim
Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe, Offenbach
Centro Médico Zambrano Hellion, Monterrey
Centre Léon Bérard, Lyon
Institut Curie; Oncologie Medicale, Paris
APHP - Hospital Saint Louis, Paris
Oncologico Potosino, San Luis Potosí City
Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica, Napoli
Università degli Studi Federico II; Clinica di Oncologia Medica, Napoli
Institut Sainte Catherine, Avignon
Klinikum Augsburg; Frauenklinik, Augsburg
San Juan Oncology Associates, Farmington
Songklanagarind Hospital; Department of Surgery, Songkhla
Northwest Medical Specialties, Lakewood
Moscow City Oncology Hospital #62, Moscovskaya Oblast
Ivanovo Regional Oncology Dispensary, Ivanovo
Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological), Saint Petersburg
Clinical Oncology Dispensary of Ministry of Health of Tatarstan, Kazan'
Omsk Region Clinical Oncology Dispensary; 1St Sergical Department, Omsk
Fundación CENIT para la Investigación en Neurociencias, Buenos Aires
Centro Oncologico Riojano Integral (CORI), La Rioja
COIBA, Provincia de Buenos Aires
Hospital Araujo Jorge; Departamento de Ginecologia E Mama, Goiânia
Hospital Nossa Senhora da Conceicao, Porto Alegre
Hospital Perola Byington, São Paulo
Royal Victoria Hospital, Barrie
Lakeridge Health Center; R. S. MacLaughlin Durham Regional Cancer Center, Oshawa
The Ottawa Hospital Cancer Centre, Ottawa
Jewish General Hospital, Montreal
Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont, Sherbrooke
Masarykuv onkologicky ustav, Brno
Multiscan s.r.o., Pardubice
National Hospital Organization Kyushu Cancer Center, Fukuoka
Gifu University Hospital, Gifu
Hiroshima City Hiroshima Citizens Hospital, Hiroshima
Hiroshima University Hospital, Hiroshima
National Hospital Organization Hokkaido Cancer Center, Hokkaido
Hyogo Medical University Hospital, Hyōgo
Sagara Hospital, Kagoshima
Kanagawa Cancer Center, Kanagawa
Tokai University Hospital, Kanagawa
Fukushima Medical University Hospital, Miyagi
Niigata Cancer Center Hospital, Niigata
Okayama University Hospital, Okayama
Osaka International Cancer Institute, Osaka
Saitama Medical University International Medical Center, Saitama
St. Luke's International Hospital, Tokyo
The Cancer Institute Hospital of JFCR, Tokyo
Iem-Fucam, D.F.
Bialostockie Centrum Onkologii im. Marii Sklodowskiej - Curie, Bialystok
Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; Centr.Diagn.i Lecz.Chor.Piersi, Gliwice
Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Onkologii i Poradnia Onkologiczna, Krakow
Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych, Szczecin
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr, Warsaw
Dolnoslaskie Centrum Onkologii, Wroclaw
Seoul National University Bundang Hospital, Seongnam-si
Seoul National University Hospital, Seoul
Asan Medical Center, Seoul
Hospital del Mar; Servicio de Oncologia, Barcelona
Institut Catala d Oncologia Hospital Duran i Reynals, Barcelona
VETERANS GENERAL HOSPITAL; Department of General Surgery, Taipei
Brighton and Sussex Univ Hosp, Brighton
Velindre Cancer Centre, Cardiff
St Georges University Hospitals NHS Foundation Trust, London
Christie Hospital NHS Trust, Manchester
Freeman Hospital, Newcastle upon Tyne
Nottingham City Hospital, Nottingham
Peterborough City Hospital, Peterborough
Hoffmann-La Roche
INDUSTRY