Keynote B49
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) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10.
CLINICALTRIALS.GOV IDENTIFIER:
NCT04895358
When speaking to your doctor, please have the trial identifier number available.
All patients who enrol in the trial will receive chemotherapy.
50% will receive pembrolizumab along with chemotherapy
50% will receive placebo along with chemotherapy
Tests the medicine or vaccine in large groups of trial participants (from several hundred to several thousand). For medicines, volunteers have the disease or condition the medicine is designed to treat. In vaccine studies, the volunteers may be healthy or have diseases or conditions. Phase 3 trials take place in hospitals, clinics, or physician offices.
Dates
Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in starting a conversation with your doctor.
Conditions
Breast Neoplasms
Age Range
18 - No Age Maximum
Sex
All
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