Study on Preoperative Chemotherapy, Pembrolizumab, and Radiation for Node-Positive, Triple Negative Breast Cancer
Sponsor: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials ID:NCT07276880
This clinical trial is exploring the best dose of radiation therapy to use alongside chemotherapy and pembrolizumab for treating patients with node-positive, triple negative breast cancer before surgery.
Patient Parameters
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Program Overview
This study aims to find the best dose of radiation therapy to use with chemotherapy and pembrolizumab, an immune therapy, for patients with node-positive, triple negative breast cancer. The trial involves 32 patients who will be randomly assigned to receive either a low or high dose of radiation to their breast tumor over three days. The first dose of pembrolizumab will be given within two days of starting radiation. Patients will also have biopsies taken from their tumor and lymph nodes for research purposes. After this initial treatment, patients will continue with standard chemotherapy and pembrolizumab, followed by surgery to remove the breast tumor and lymph nodes. After surgery, patients may receive additional standard treatments as needed. Follow-up visits will occur every six months for three years, with some side effects monitored for up to five years.
Eligibility Criteria
Inclusion Criteria
- Must provide written consent to participate and agree to share health information.
- Must be 18 years or older.
- Must be in good overall health, able to perform daily activities with little or no assistance.
Exclusion Criteria
- Cannot have an active infection that needs treatment.
- Cannot be pregnant or breastfeeding.
- Cannot have had previous radiation treatment to the same breast or chest area.
- Cannot have had another invasive breast cancer or other progressing cancer in the last five years.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of North Carolina | 27599 | Chapel Hill | North Carolina |
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