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

Who is this study for? Adult female patients over age 21 with metastatic breast cancer
What treatments are being studied? Pembrolizumab+Intraoperative radiation therapy 
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: Female
Minimum Age: 21
Maximum Age: 80
Healthy Volunteers: f
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• Be willing and able to provide written informed consent/assent for the trial.

• Be ≥ 21 years of age on day of signing informed consent.

• 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.

• Clinically ≤ 3 cm unifocal lesion by imaging or physical examination.

• Clinically node negative, no evidence of metastatic disease.

• No prior anti-cancer therapy including investigational agents, radiation therapy, or breast resection within 6 months of study entry.

• Breast size B cup or larger, to allow for IORT procedure.

• Have a performance status of 0 or 1 on the ECOG Performance Scale.

• Demonstrate adequate organ function.

⁃ Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

⁃ Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication.

Locations
United States
Georgia
Emory University
RECRUITING
Atlanta
Illinois
Loyola University Chicago
RECRUITING
Maywood
New York
Columbia University Irving Medical Center
RECRUITING
New York
Contact Information
Primary
Eileen Connolly, MD
epc2116@cumc.columbia.edu
212-305-5050
Backup
Radiation Oncology Research Department
212-305-5050
Time Frame
Start Date: 2017-10-25
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 15
Treatments
Experimental: Single Arm open label
Participants receive 'Merck 3475 Pembrolizumab' by vein one to two times before Intraoperative radiation therapy (IORT).~The Intrabeam® Photon Radiosurgery System is a miniature electron beam-driven X-ray source which provides a point source of low energy X-rays (50 kV maximum) at the tip of a 3.2 mm diameter tube. The radiation source can be inserted into the area of interest immediately after excision of the tumor and switched on for 20-35 minutes to provide intraoperative radiotherapy accurately targeted to the tissues that are at the highest risk of local recurrence. The dosimetric characteristics and early clinical applications of this device have been well studied and this is the device which was utilized in the international TARGIT trial.
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: Eileen Connolly

This content was sourced from clinicaltrials.gov