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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT07276880
Phase
PHASE2
Status
Recruiting
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Conditions

  • Breast Cancer
  • HER2-Negative Breast Carcinoma
  • Node-positive Breast Cancer
  • Triple Negative Breast Cancer (TNBC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neoadjuvant Pembrolizumab — DRUG
    200 milligrams per square meter Neoadjuvant Pembrolizumab will be administered intravenously.
  • low dose neoadjuvant boost — RADIATION
    An external beam radiotherapy boost of 9Gy total will be administered over 3 fractions.
  • High dose neoadjuvant boost — RADIATION
    An external beam radiotherapy boost of 24Gy total will be administered over 3 fractions.

Study Details

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 fractions over 3 days. In the Neoadjuvant Phase, the first cycle (C1) of pembrolizumab (200 mg i.v.) will be administered within 0-2 days of initiating RT. Participation in this study requires availability of residual diagnostic tissue biopsies of the primary tumor and metastatic lymph node for research use. If this tissue is not available, baseline research biopsies will be performed. Additionally, a research biopsy of the breast tumor and lymph node is required on Day 10-14 of C1 of pembrolizumab. After completion of the research biopsy in Week 2, the participants can commence standard-of-care neoadjuvant chemotherapy and pembrolizumab at the discretion of their medical oncology provider. After completing NAC, participants will undergo standard of care surgical resection of the breast and axillary lymph nodes, at the discretion of their surgical oncology provider. In the Adjuvant Phase, participants will receive standard of care adjuvant systemic therapy and standard of care adjuvant radiotherapy (if indicated), although recognizing that the breast tumor boost portion of this treatment has already been administered preoperatively. Except for late radiation adverse reactions of special interest, which will be followed yearly for up to 5 years, follow-up will occur every 6 months for 3 years.

Key Dates

Start date
Mar 17, 2026
Status verified
Apr 2026
Primary completion
Nov 30, 2027
Completion
Jan 31, 2032

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ARM 1
    Participants will receive a low dose radiation therapy boost in 3 fractions (3Gy x 3 fraction = 9Gy total).
  • Experimental: ARM 2
    Participants will receive a high dose radiation therapy boost in 3 fractions (8Gy x 3 fraction = 24Gy total).

Primary Outcome Measure

Nodal Pathologic Complete Response rate(pCR) [ Time Frame: Time of surgery (24 week) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North CarolinaChapel HillNorth Carolina27599
Taylor Pierce
[email protected]
984-974-0400
Dana Casey, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of North Carolina· Chapel Hill, NC

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