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Study of Pembrolizumab and Radiation for Node-Positive Triple Negative Breast Cancer

This study is for people with operable, lymph node-positive, triple negative breast cancer (a type of breast cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein). It's looking for the best dose of radiation therapy to use with pembrolizumab (an immunotherapy drug that helps your immune system fight cancer) and standard chemotherapy before surgery. You would receive pembrolizumab intravenously (through a vein) along with either a low dose or a high dose of radiation. The main goal is to see how many participants have no cancer cells found in their lymph nodes at the time of surgery (called a Nodal Pathologic Complete Response). This study plans to enroll 32 participants and is currently unclear on its recruitment status. You must be at least 18 years old to participate.

Study design
This is a Phase 2 study, part of a larger research effort, that aims to find the best radiation dose. It plans to enroll 32 participants.
What's involved
You would receive pembrolizumab and radiation therapy before surgery. You must be willing and able to follow study procedures.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, Nodal Pathologic Complete Response, is measured at the time of surgery (24 weeks).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07276880

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
UNC Lineberger Comprehensive Cancer Center
~32 participants
Updated 2026-04-27 on ClinicalTrials.gov
What's tested:Neoadjuvant Pembrolizumablow dose neoadjuvant boostHigh dose neoadjuvant boost

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Nodal Pathologic Complete Response rate(pCR)
Measured over Time of surgery (24 week)

Conditions

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

Explore related trials

Breast CarcinomaTriple-negative breast cancer

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Dana Casey, MD · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center

Who to contact

Taylor Pierce
[email protected]
919-984-0000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Nodal Pathologic Complete Response rate(pCR)Time of surgery (24 week)

    Nodal pCR is defined in a patient with no residual cancer cells in all sampled regional lymph nodes following completion of neoadjuvant systemic therapy as assessed by the study pathologist at the time of definitive surgery. Nodal pCR rates will be calculated and analyzed separately for patients receiving low versus high dose RT. A pooled analysis, incorporating the corresponding (3Gyx3 or 8Gyx3) patient cohort from the P-RAD trial, will be performed.