Phase II Study of Pembrolizumab and Nab-paclitaxel in HER-2 Negative Metastatic Breast Cancer
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
This is a single-arm open-label multi-cohort Phase II study evaluating the
safety/tolerability and clinical activity of the combination of nab-paclitaxel and the
antibody against programmed cell death 1 (PD-1), pembrolizumab, in patients with human
epidermal growth factor receptor (HER-2) negative metastatic breast cancer (n=50). There will
be two cohorts of patients consisting of a triple negative breast cancer (TNBC) cohort with
30 subjects and a hormone receptor (HR)-positive cohort with 20 subjects. There will be an
initial safety run-in with 12 subjects from the TNBC and HR-positive cohort (~ 6 patients
from each cohort). If no unexpected toxicity is observed (as defined in the study protocol),
then enrollment will continue to complete both cohorts (30 total TNBC, 20 total in HR
positive cohort). The subjects from the run in safety part will be included in the Phase II
analysis. Tumor expression of programmed cell death ligand 1 (PD-L1) is not required for
enrollment in the study, but will be assessed as possible predictive marker.
Details
Lead Sponsor:
New York University School of Medicine NYU Langone Health