Atezolizumab: Atezolizumab will be administered at a dose of 1200 mg every three weeks (Q3W) for 14 cycles.
Trastuzumab Emtansine: Trastuzumab emtansine will be administered at a dose of 3.6 mg/kg Q3W for 14 weeks.
Placebo: Placebo matched to atezolizumab will be administered at a dose of 1200 mg Q3W for 14 cycles.
Trastuzumab: Trastuzumab will be used to complete 14 cycles of study treatment if trastuzumab emtansine is discontinued for toxicity not considered to be related to the trastuzumab component of the drug.
This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes.
As of June 4, 2024, this study is no longer accepting any newly screened participants.
| Facility | City | Region | Status |
|---|---|---|---|
| Alabama Oncology | Birmingham | Alabama | |
| Roy and Patricia Disney Family Cancer Center- Providence Saint Joseph Medical Center | Buena | California | |
| UCLA Medical Center | Santa Monica | California | |
| Innovation Clinical Research Institute | Whittier | California | |
| Florida Cancer Specialists | West Palm Beach | Florida | |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital | Carrollton | Georgia | |
| University of Iowa | Iowa City | Iowa | |
| New England Cancer Specialists | Westbrook | Maine | |
| The Valley Hospital | Paramus | New Jersey | |
| Levine Cancer Institute | Charlotte | North Carolina | |
| Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit | Philadelphia | Pennsylvania | |
| The West Clinic | Germantown | Tennessee | |
| Thompson Cancer Survival Center | Knoxville | Tennessee | |
| Mays Cancer Center at UT Health San Antonio MD Anderson Cancer | San Antonio | Texas | |
| Hematology Oncology Associates of Fredericksburg, Inc. | Fredericksburg | Virginia | |
| Virginia Oncology Associates - New Port News | Newport News | Virginia | |
| Virginia Oncology Associates | Norfolk | Virginia | |
| Virginia Cancer Institute | Richmond | Virginia | |
| Virginia Oncology Associates - Virginia Beach | Virginia Beach | Virginia | |
| Providence Regional Cancer Partnership | Everett | Washington | |
| Kadlec Clinic Hematology and Oncology | Kennewick | Washington | |
| Northwest Medical Specialties | Tacoma | Washington | |
| Macarthur Cancer Therapy Centre | Campbelltown | New South Wales | |
| Royal North Shore Hospital | St Leonards | New South Wales | |
| Princess Alexandra Hospital | Woolloongabba | Queensland | |
| Tiroler Landeskrankenanstalten Ges.M.B.H. | Innsbruck | Austria | |
| Ordensklinikum Linz Barmherzige Schwestern | Linz | Austria | |
| Lkh Salzburg - Univ. Klinikum Salzburg | Salzburg | Austria | |
| Cliniques Universitaires St-Luc | Brussels | Belgium | |
| Jessa Zkh (Campus Virga Jesse) | Hasselt | Belgium | |
| Clinique St. Elizabeth | Namur | Belgium | |
| Crio - Centro Regional Integrado de Oncologia | Fortaleza | Ceará | |
| Hospital Sao Rafael - HSR | Salvador | Estado de Bahia | |
| Hospital Araujo Jorge | Goiânia | Goiás | |
| Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda | Ijuí | Rio Grande do Sul | |
| Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Rio Grande do Sul | |
| Hospital Sao Lucas - PUCRS | Porto Alegre | Rio Grande do Sul | |
| Hospital Nossa Senhora da Conceicao | Porto Alegre | Rio Grande do Sul | |
| Hospital de Base de Sao Jose do Rio Preto | São José do Rio Preto | São Paulo | |
| Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda | São Paulo | São Paulo |
+ 198 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04873362 on ClinicalTrials.gov ↗ ← All trials in India