Effects of MK-3475 (Pembrolizumab) on the Breast Tumor Microenvironment in Triple Negative Breast Cancer With and Without Intra-operative RT: a Window of Opportunity Study
Eileen Connolly
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.
Description
This is an open-label, single-arm, single institution pre-operative "window of opportunity study" of pembrolizumab in subjects with newly diagnosed triple-negative, \< 3 cm, node negative breast cancer. Subjects may not have received any prior neo/adjuvant chemotherapy, definitive surgery or radiation treatment prior to enrollment. The goal of this project is to determine if immune modulation through treatment with MK-3475 (Pembrolizumab) in triple negative breast cancer (TNBC) patients will alter expression of immune tolerant markers \[including PD-L1\], within the primary tumor. Investigato…
Eligibility
- Age range
- 21–80 years
- Sex
- Female
- Healthy volunteers
- No
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 th…
Interventions
- DrugMerck 3475 Pembrolizumab
Participants receive Pembrolizumab by vein over about 30 minutes on Day 1 of one to two cycles.
- RadiationIntraoperative radiation therapy (IORT)
Participants will receive Intraoperative radiation therapy (IORT) on the day of surgery.
Locations (3)
- Emory UniversityAtlanta, Georgia
- Loyola University ChicagoMaywood, Illinois
- Columbia University Irving Medical CenterNew York, New York