Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for Locally Recurrent Inoperable or Metastatic Breast Cancer

April 18, 2022
Breast Cancer
Joseph Kash, MD
Edward Cancer Center - Naperville
Edward Cancer Center - Plainfield
Nancy Knowles Cancer Center - Elmhurst

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.

Sponsor: Merck Sharp & Dohme Corp

  • Locally recurrent inoperable or metastatic HR+/HER2- breast cancer, which has not been previously treated with cytotoxic chemotherapy in the noncurative setting
  • Documented progression on prior treatment 
  • Tumor is PD-L1 positive, hormone receptor positive, and HER2 negative 
  • No significant cardiac disease, advanced/metastatic cancer, or skin only disease
  • No prior chemotherapy for locally recurrent inoperable or metastatic breast cancer
  • No active autoimmune disease that has required systemic treatment in past 2 years
  • No history of (noninfectious) pneumonitis that required steroids or has current pneumonitis
  • No active infection requiring systemic therapy, history of HIV, or history of TB
Approx. 6 years
Pending IRB Approval for Recruiting
Jessica Schnase, Mgr Cancer Research