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Can adding radiation to immunotherapy and chemotherapy boost breast cancer treatment?

NCT ID NCT07276880

Disease control Sponsor: UNC Lineberger Comprehensive Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether adding low or high dose radiation to standard chemotherapy and the immunotherapy drug pembrolizumab can improve treatment for people with node-positive triple negative breast cancer. Thirty-two participants will be randomly assigned to receive either low or high dose radiation to the breast tumor before surgery. The main goal is to see which dose leads to a higher rate of complete cancer clearance in the lymph nodes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pembrolizumab (immunotherapy drug) and radiation therapy
What this could lead to
If successful, this could help determine the best radiation dose to boost the immune system's response against triple negative breast cancer when combined with immunotherapy and chemotherapy.
What could go wrong
This is a small, early-phase trial with only 32 participants, so results may not apply to all patients. The added radiation could increase side effects, and it's unclear if it will improve outcomes over standard treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jan 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Her2-receptor negative breast cancer triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer HER2-negative breast carcinoma Node positive breast cancer Triple negative breast cancer (TNBC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of North Carolina

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

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