Preoperative chemotherapy with pembrolizumab and a low or high radiation boost for node-positive triple-negative breast cancer
Preoperative Chemotherapy, Pembrolizumab and Low or High Dose RADiation in an Expansion Cohort of Node(+), Triple Negative Breast Cancer
This study tests whether giving a low or high radiation boost together with preoperative chemotherapy and pembrolizumab can better activate the immune system in people with node‑positive triple‑negative breast cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | Pembrolizumab, Chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT07276880 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (age ≥18) with operable, lymph node‑positive, triple‑negative, HER2‑negative breast cancer who are eligible for neoadjuvant chemo‑immunotherapy and have ECOG performance status 0–1 are ideal candidates.
Not a fit: Patients who are pregnant or breastfeeding, have active infections, prior ipsilateral chest/breast radiotherapy, or recent progressing invasive cancers are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the study could identify a radiation dose that enhances immune activation and improves tumor response before surgery.
How similar studies have performed: Pembrolizumab added to neoadjuvant chemotherapy has improved outcomes in KEYNOTE‑522, but using short focused radiation boosts to specifically amplify that immune effect in this setting is a relatively novel approach with limited clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chapel Hill, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.