Preoperative chemotherapy with pembrolizumab and a low or high radiation boost for node-positive triple-negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2 expansion cohort of the multicenter P-RAD program enrolling operable, lymph node‑positive, triple‑negative, HER2‑negative breast cancer patients who are candidates for standard neoadjuvant chemo‑immunotherapy. Thirty‑two participants will be randomized 1:1 to receive either a low radiation boost (9 Gy total) or a high radiation boost (24 Gy total), both delivered to the intact breast tumor in three daily fractions. Pembrolizumab (200 mg i.v.) is given as part of the first neoadjuvant cycle alongside standard chemotherapy per KEYNOTE‑522 eligibility, and radiation is timed to combine with the immune checkpoint inhibitor. The primary goal is to identify the radiation dose that elicits the strongest immune response when combined with pembrolizumab and neoadjuvant chemotherapy.

Why it matters

Who can join: the full rules

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

Where it's running

• University of North Carolina
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Dana Casey, MD — UNC Lineberger Comprehensive Cancer Center
• Study coordinator: Taylor Pierce
• Email: Taylor_Pierce@med.unc.edu
• Phone: 919-984-0000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.