Breast Cancer Clinical Trial
Official title:
A Phase II Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients: Big Ten Cancer Research Consortium BTCRC-BRE16-042
Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients
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.
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