Trial Profile

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)

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 06 Mar 2025

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At a glance

Drugs Pembrolizumab (Primary) ; Capecitabine; Doxorubicin liposomal; Glucose; Paclitaxel
Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
Focus Therapeutic Use
Acronyms KEYNOTE-B49; MK-3475-B49/KEYNOTE-B49
Sponsors Merck Sharp & Dohme Corp.; MSD KK

03 Mar 2025 Planned End Date changed from 21 Mar 2025 to 18 Dec 2027.
03 Mar 2025 Planned primary completion date changed from 21 Mar 2025 to 18 Dec 2027.
13 Nov 2024 Planned End Date changed from 21 Jul 2028 to 21 Mar 2025.

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