RecruitingPhase 1NCT02977468

Effects of MK-3475 (Pembrolizumab) on the Breast Tumor Microenvironment in Triple Negative Breast Cancer

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


Sponsor

Eileen Connolly

Enrollment

15 participants

Start Date

Oct 25, 2017

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 21 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an immunotherapy drug called pembrolizumab (also known as Keytruda) can help the immune system attack early-stage triple-negative breast cancer — a type that does not respond to hormone-based treatments — before surgery. **You may be eligible if...** - You are 21 years of age or older - You have been diagnosed with invasive triple-negative breast cancer (a type that is negative for estrogen, progesterone, and HER2 receptors) - Your tumor is 3 cm or smaller and in one location - You have not yet had surgery or chemotherapy for this cancer **You may NOT be eligible if...** - You have had prior chemotherapy or radiation therapy for breast cancer - You have cancer that has spread beyond the breast or nearby lymph nodes - You are pregnant or breastfeeding - You have a serious autoimmune disease or are on immune-suppressing medications - You have other significant health conditions that could interfere with treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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 University

Atlanta, Georgia, United States

Loyola University Chicago

Maywood, Illinois, United States

Columbia University Irving Medical Center

New York, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT02977468


Related Trials