Preoperative Chemotherapy, Pembrolizumab and Low or High Dose RADiation in an Expansion Cohort of Node(+), Triple Negative Breast Cancer
NCT ID: NCT07276880
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
32 participants
INTERVENTIONAL
2026-01-31
2032-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ARM 1
Participants will receive a low dose radiation therapy boost in 3 fractions (3Gy x 3 fraction = 9Gy total).
Neoadjuvant Pembrolizumab
200 milligrams per square meter Neoadjuvant Pembrolizumab will be administered intravenously.
low dose neoadjuvant boost
An external beam radiotherapy boost of 9Gy total will be administered over 3 fractions.
ARM 2
Participants will receive a high dose radiation therapy boost in 3 fractions (8Gy x 3 fraction = 24Gy total).
Neoadjuvant Pembrolizumab
200 milligrams per square meter Neoadjuvant Pembrolizumab will be administered intravenously.
High dose neoadjuvant boost
An external beam radiotherapy boost of 24Gy total will be administered over 3 fractions.
Interventions
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Neoadjuvant Pembrolizumab
200 milligrams per square meter Neoadjuvant Pembrolizumab will be administered intravenously.
low dose neoadjuvant boost
An external beam radiotherapy boost of 9Gy total will be administered over 3 fractions.
High dose neoadjuvant boost
An external beam radiotherapy boost of 24Gy total will be administered over 3 fractions.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Merck Sharp & Dohme LLC
INDUSTRY
UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Dana Casey, MD
Role: PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Locations
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University of North Carolina
Chapel Hill, North Carolina, United States
Countries
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Central Contacts
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Related Links
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University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
Other Identifiers
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LCCC2426-DCT
Identifier Type: -
Identifier Source: org_study_id
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