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

RecruitingPhase 2Ages 18 Years - anyAllUNC Lineberger Comprehensive Cancer Center
NCT07276880 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 candidates for standard of care neoadjuvant chemo-immunotherapy (NAC) based on the KEYNOTE-522 clinical trial. Thirty-two (n=32) patients will be randomized 1:1 to receive either low RT boost (9Gy total) or high RT boost (24Gy total). All RT will be delivered to the intact breast tumor in 3 daily fr

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📋 Eligibility rules (as published)
Inclusion 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 willing and able * to comply with study procedures based on the judgment of the investigator. * Age ≥ 18 years at the time of consent. * ECOG or Karnofsky Performance Status of 0 or 1 Exclusion Criteria: * Active infection requiring systemic therapy. * Pregnant or breastfeeding. * Prior ipsilateral invasive breast, chest wall or thoracic radiotherapy * Prior ipsilateral invasive breast cancer, contralateral breast cancer or a known * additional, invasive malignancy that is progressing or required active treatment in * the last 5 years
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What it tests

  • Neoadjuvant Pembrolizumab
  • low dose neoadjuvant boost
  • High dose neoadjuvant boost
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Where

1 site
University of North Carolina
Chapel Hill, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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