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Clinical Trial Summary

Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients


Clinical Trial Description

This is a non-randomized, multi-site, open-label Phase II trial for subjects with metastatic, hormone receptor positive, HER2 negative breast cancer. The study will enroll 47 patients to evaluate the anti-tumor activity of pembrolizumab with fulvestrant as measured by RECIST 1.1 tumor response and by progression free survival. We expect that if the immune response is augmented by the addition of pembrolizumab, significant change in durability of response will be noted.

Patients will be treated with pembrolizumab dosed at 200 mg intravenous infusion in combination with standard fulvestrant 500mg intramuscular injection. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03393845
Study type Interventional
Source Big Ten Cancer Research Consortium
Contact Nancy Chan, MD
Phone 1 732-235-9692
Email cheungna@cinj.rutgers.edu
Status Recruiting
Phase Phase 2
Start date January 29, 2018
Completion date January 1, 2022

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