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A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49)
Merck Sharp & Dohme Corp.
This is a randomised, double-blind study with experimental and active comparator arms. In the Experimental Arm, participants will receive pembrolizumab + chemotherapy. Pembrolizumab will be administered via intravenous infusion (IV) at a dose of 200mg on Day 1 of each 21-day cycle (Q3W). In the Active Comparator Arm, participants will receive a placebo + chemotherapy. The placebo will be administered via IV on Day 1 Q3W. For all participants, the investigator will decide which chemotherapy regimen participants will receive, out of four possible options: 1) paclitaxel 90 mg/m^2 IV on Days 1, 8, and 15 of each 28-day cycle (Q4W), 2) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8, and 15 Q4W, 3) liposomal doxorubicin 50 mg/m^2 IV on Day 1 Q4W, OR 4) capecitabine 1000 mg/m^2 by oral administration (PO) twice a day (BID) on Days 1-14 Q3W for up to 35 administrations.