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

NCT02977468 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-06-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Merck 3475 Pembrolizumab

Participants receive Pembrolizumab by vein over about 30 minutes on Day 1 of one to two cycles.

RADIATION

Intraoperative radiation therapy (IORT)

Participants will receive Intraoperative radiation therapy (IORT) on the day of surgery.

Sponsors & Collaborators

Principal Investigators

  • Eileen Connolly, MD · Assistant Professor Of Radiation Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-25
Primary Completion
2024-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02977468 on ClinicalTrials.gov