Preoperative Chemotherapy, Pembrolizumab and Low or High Dose RADiation in an Expansion Cohort of Node(+), Triple Negative Breast Cancer

This is a prospective radiation dose-finding, phase 2 expansion study of the Triple Negative (TN) cohort of the multicenter randomized study P-RAD (A Randomized Study of Preoperative Chemotherapy, Pembrolizumab and No, Low or High Dose RADiation in Node-Positive, HER2-Negative Breast Cancer; NCT04443348) that seeks to establish the optimal dose of radiation therapy (RT) to elicit an immune response when combined with immune checkpoint inhibitor (ICI) in breast cancer patients. Eligible subjects include women or men with operable, lymph node-positive, triple negative (TN) breast cancer who are

Trial Details

NCT ID
NCT07276880
Phase
PHASE2
Sponsor
UNC Lineberger Comprehensive Cancer Center
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Neoadjuvant Pembrolizumab
  • low dose neoadjuvant boost
  • High dose neoadjuvant boost
Locations (sample)
  • Chapel Hill, North Carolina, United States|35.9132,-79.05584

Key Eligibility Criteria

  • In order to participate in this study, a subject must meet all of the eligibility criteria outlined below.
  • Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Subjects are will…
  • to comply with study procedures based on the judgment of the investigator.
  • Age ≥ 18 years at the time of consent.

For full eligibility, visit ClinicalTrials.gov.

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