Phase I/II trial of palbociclib, pembrolizumab and letrozole in patients with hormone receptor-positive metastatic breast cancer.

ABSTRACT:

Background

CDK4/6 inhibitors modulate immune response in breast cancer. This phase I/II trial was designed to test the safety and efficacy of palbociclib, pembrolizumab and letrozole in women with hormone receptor positive (HR⁺) human epidermal growth factor receptor 2 negative (HER2^-) metastatic breast cancer (MBC).

Patients and methods

Women with stage IV HR⁺ HER2^- MBC were enrolled and treated with palbociclib, pembrolizumab and letrozole. Primary end-points were safety, tolerability and efficacy.

Results

Between November 2016 and July 2020, 23 patients were enrolled with 20 evaluable for response, including 4 patients in cohort 1 and 16 patients in cohort 2. Cohort 1 median age was 48 years (33-70) and cohort 2 median ag

SUBMITTER: Yuan Y 

PROVIDER: S-EPMC8691850 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature