EICHOR
● Active Not Recruiting
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)
Condition: Breast Neoplasms · Sponsor: Merck Sharp & Dohme LLC
About this study
The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer. The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1. Prior to protocol amendment 7, participants who discontinued pembrolizumab/placebo with SD or better and subsequently experienced disease progression may have been eligible for up to 17 additional administrations of pembrolizumab if, upon unblinding, they were found to have received pembrolizumab, at the same dose and schedule used for the initial treatment period.
This description comes directly from the study's public registry record.
Talk to the study team
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Locations (256)
| University of Alabama at Birmingham-Medicine ( Site 0065) | Birmingham, Alabama, United States | — |
| Arizona Oncology Associates-Arizona Oncology ( Site 0049) | Tucson, Arizona, United States | — |
| Pacific Cancer Care ( Site 0023) | Monterey, California, United States | — |
| UCSF Medical Center at Mission Bay ( Site 0043) | San Francisco, California, United States | — |
| Georgetown University Medical Center-Department of Medicine and Oncology ( Site 0026) | Washington D.C., District of Columbia, United States | — |
| MedStar Washington Hospital Center ( Site 0063) | Washington D.C., District of Columbia, United States | — |
| Baptist MD Anderson Cancer Center ( Site 0013) | Jacksonville, Florida, United States | — |
| Miami Cancer Institute at Baptist Health, Inc. ( Site 0070) | Miami, Florida, United States | — |
| Miami Cancer Institute - Plantation ( Site 0076) | Plantation, Florida, United States | — |
| University Cancer & Blood Center, LLC ( Site 0032) | Athens, Georgia, United States | — |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0028) | Marietta, Georgia, United States | — |
| University of Illinois at Chicago ( Site 0061) | Chicago, Illinois, United States | — |
+ 244 more locations — full list on the registry record.
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