Stage IV Breast Cancer Clinical Trial
Official title:
Phase II Study of Pembrolizumab and Capecitabine for Advanced Triple Negative and Hormone-Refractory Breast Cancer
The purpose of this study is to see whether a combination of two different drugs - pembrolizumab and capecitabine - is safe, and if it might be effective in treating triple negative and hormone-refractory breast cancer. Pembrolizumab is a type of drug that contains an antibody. Antibodies are the part of your immune system that finds things that don't belong in your body, such as bacteria or viruses. The antibody in pembrolizumab finds and blocks a protein, which allows your immune system to target and destroy cancer cells. Pembrolizumab is Food and Drug Administration (FDA) approved for other types of cancer. It is not approved for breast cancer, meaning that it is an "experimental" or "investigational" treatment. Capecitabine is a type of chemotherapy pill that is a standard treatment and FDA-approved for breast cancer. It stops the cancer cells from being able to multiply.
PRIMARY OBJECTIVES:
I. To evaluate the median progression-free survival (median PFS) for participants receiving
pembrolizumab with capecitabine for the treatment of locally advanced or metastatic triple
negative breast cancer (TNBC) and hormone-refractory metastatic breast cancer (MBC).
SECONDARY OBJECTIVES:
I. To describe the objective response rate (ORR) for participants receiving pembrolizumab
with capecitabine for the treatment of locally advanced or metastatic TNBC and
hormone-refractory MBC.
II. To describe the safety and tolerability of the combination of pembrolizumab and
capecitabine for the treatment of locally advanced or metastatic TNBC and hormone-refractory
MBC.
TERTIARY OBJECTIVES:
I. Analysis of expression of programmed cell death 1 ligand 1 (PD-L1) through
immunohistochemical (IHC) analysis.
II. To assess circulating tumor DNA (ctDNA). III. To evaluate ORR and median-PFS using
immune-related Response Evaluation Criteria in Solid Tumors (irRECIST).
OUTLINE:
Patients receive pembrolizumab intravenously (IV) on day 1 and capecitabine orally (PO) twice
daily (BID) on days 1-14. Courses repeat every 21 days in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 2
years.
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