Actively Recruiting
Effects of MK-3475 (Pembrolizumab) on the Breast Tumor Microenvironment in Triple Negative Breast Cancer
Led by Eileen Connolly · Updated on 2024-06-20
15
Participants Needed
3
Research Sites
427 weeks
Total Duration
On this page
Sponsors
E
Eileen Connolly
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of MK-3475 (Pembrolizumab) on the Breast Tumor Microenvironment in Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent
- Age 21 years or older at consent
- Histologically confirmed invasive triple negative breast cancer (ER, PR, HER2 negative; ER/PR positive ≤ 10%)
- Single breast tumor 3 cm or smaller by imaging or physical exam
- Clinically node negative with no metastatic disease
- No prior anti-cancer therapy including chemotherapy, radiation, or breast surgery within 6 months
- Breast size B cup or larger for intraoperative radiation therapy
- ECOG performance status of 0 or 1
- Adequate organ function
- Negative pregnancy test within 72 hours before first dose for females of childbearing potential
- Willingness to use contraception during study and for 120 days after last dose for females of childbearing potential
You will not qualify if you...
- Multifocal breast disease
- Primary tumor larger than 3 cm or pathologically proven nodal disease
- Metastatic disease
- Active or progressing additional malignancy within 5 years (with some exceptions)
- Contraindication to radiotherapy (e.g., connective tissue disorder, prior ipsilateral breast radiation)
- Immunodeficiency or recent immunosuppressive therapy
- Active tuberculosis
- Severe hypersensitivity to pembrolizumab or its components
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis requiring steroids
- Active infection needing systemic therapy
- Any condition interfering with study participation or safety
- Psychiatric or substance abuse disorders affecting cooperation
- Pregnant, breastfeeding, or planning pregnancy during study and 120 days after
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or similar agents
- Active Hepatitis B or C infection
- Live vaccine within 30 days before study therapy
- History of allogenic stem cell or solid organ transplant
- Known HIV infection
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
Loyola University Chicago
Maywood, Illinois, United States, 60153
Actively Recruiting
3
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
E
Eileen Connolly, MD
CONTACT
R
Radiation Oncology Research Department
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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