Effects of MK-3475 (Pembrolizumab) on the Breast Tumor Microenvironment in Triple Negative Breast Cancer
Trial Parameters
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Brief Summary
Assess response to pembrolizumab in both primary tumor, normal breast stroma, circulating lymphocytes and serum exosomes in treatment naive triple negative breast cancer (TNBC) patients. Assess for change in tumor-infiltrating lymphocytes (TILS) both stromal (sTILS) and intraepithelial (iTILS) in newly diagnosed early stage TNBC patients treated with two doses of MK-3475 prior to lumpectomy.
Eligibility Criteria
Inclusion Criteria: 1. Be willing and able to provide written informed consent/assent for the trial. 2. Be ≥ 21 years of age on day of signing informed consent. 3. Histologically proven invasive breast carcinoma with triple negative receptor status (Estrogen receptor, Progesterone receptor and HER2 negative by IHC and FISH). Patients who are weekly positive for the estrogen or progesterone receptor (i.e., \< or = 10%) are eligible. 4. Clinically ≤ 3 cm unifocal lesion by imaging or physical examination. 5. Clinically node negative, no evidence of metastatic disease. 6. No prior anti-cancer therapy including investigational agents, radiation therapy, or breast resection within 6 months of study entry. 7. Breast size B cup or larger, to allow for IORT procedure. 8. Have a performance status of 0 or 1 on the ECOG Performance Scale. 9. Demonstrate adequate organ function. 10. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to r