347
Participants
Start Date
July 5, 2022
Primary Completion Date
November 20, 2024
Study Completion Date
December 31, 2025
Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC)
PH FDC SC is administered subcutaneously (SC) as a fixed non-weight-based dose. A loading dose of 1200 milligram (mg) pertuzumab, 600 mg trastuzumab, and 30,000 units of recombinant human PH20 hyaluronidase (rHuPH20) is given in the first cycle (1 cycle is 21 days). In subsequent cycles, maintenance doses of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units rHuPH20 are administered once every 3 weeks (Q3W).
Pertuzumab IV
Pertuzumab is given as a fixed dose of 840 mg intravenous (IV) loading dose and then 420 mg IV for subsequent maintenance doses once every 3 weeks.
Trastuzumab IV
Trastuzumab is given as an 8 milligram per kilogram (mg/kg) intravenous (IV) loading dose and then 6 mg/kg IV for subsequent maintenance doses once every 3 weeks.
Trastuzumab Emtansine
Trastuzumab emtansine will be given at a dose of 3.6 mg/kg by intravenous (IV) infusion, once every 3 weeks.
Investigator's Choice of Chemotherapy
Option 1: Docetaxel and carboplatin once every 3 weeks for 6 cycles; Option 2: Doxorubicin plus cyclophosphamide once every 3 weeks for 4 cycles, followed by a taxane (docetaxel once every 3 weeks for 4 cycles or paclitaxel once every week for 12 cycles); Option 3: Dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks for 4 cycles, followed by a taxane (docetaxel once every 3 weeks for 4 cycles or paclitaxel once every week for 12 cycles).
Surgery
After completing their neoadjuvant therapy, participants will undergo surgical resection for early or locally advanced HER2+ breast cancer (if eligible for surgery). Participants may undergo breast-conserving surgery or mastectomy according to routine clinical practice. The surgery cannot be performed ≤2 weeks from the last systemic neoadjuvant therapy and must be performed ≤6 weeks after the last systemic neoadjuvant therapy.
Radiotherapy
After surgery, radiotherapy is to be given as clinically indicated and as per local practice or institutional standards. The selected radiotherapy regimen should be initiated within 4 weeks after surgery.
MHAT Nadezhda, Sofia
Medical Oncology Centre of Rosebank, Johannesburg
Complex Oncology Center - Plovdiv First Internal Chemotherapy Department, Plovdiv
Multiprofile Hospital for Active Treatment Uni Hospital, Panagyurishte
Instituto Regional de Enfermedades Neoplásicas del Sur, Arequipa
Clinical Hospital Centre Zagreb, Zagreb
Clinica CIMCA, San José
ICIMED Instituto de Investigación en Ciencias Médicas, San José
Hospital Metropolitano (Sede Lindora-Santa Ana), San José
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department, Edirne
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico, Jaén
International Cancer Institute (ICI), Eldoret
Hospital Universitario Virgen de Arrixaca, Murcia
Ba?c?lar Medipol Mega Üniversite Hastanesi, Istanbul
Hospital Clinico Universitario de Salamanca, Salamanca
Cantonal Hospital Zenica, Zenica
University Clinical Center of the Republic of Srpska, Banja Luka
Oncologico Potosino, San Luis Potosí City
National Cancer Centre, Singapore
Tan Tock Seng Hospital, Singapore
Saifee Hospital, Mumbai
TATA Medical Centre, Kolkata
Clinica Vespucio, Santiago
Fundación CENIT para la Investigación en Neurociencias, Buenos Aires
Centro Oncologico Korben, Ciudad Autonoma Buenos Aires
Crio - Centro Regional Integrado de Oncologia, Fortaleza
Hospital Araujo Jorge, Goiânia
Hospital Nossa Senhora da Conceicao, Porto Alegre
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda, São Paulo
Royal Victoria Regional Health Centre, Barrie
Lakeridge Health Oshawa, Oshawa
North York General Hospital, Toronto
Jewish General Hospital, Montreal
Hopital du Saint Sacrement, Québec
Centro de Estudios Clínicos SAGA, Santiago
Aga Khan University Hospital, Nairobi
Iem-Fucam, D.F.
Health Pharma Professional Research, Mexico City
Oncocenter Peru S.A.C., Lima
Wilgers Oncology Centre, Pretoria
Korea University Anam Hospital, Seoul
Samsung Medical Center, Seoul
Gulhane Training and Research Hospital, Ankara
Ankara City Hospital, Ankara
Hacettepe Uni Medical Faculty Hospital, Sihhiye/Ankara
Hoffmann-La Roche
INDUSTRY