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One-Time radiation during breast surgery could cut treatment time

NCT ID NCT06375798

Disease control Sponsor: Hebei Medical University Fourth Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Updated 1 time

Summary

This study tests whether giving a single dose of radiation during breast-conserving surgery works as well as standard weeks-long radiation for early-stage, HER2-negative breast cancer. About 620 women aged 55 and older will take part. The goal is to see if this approach lowers the chance of cancer coming back, reduces side effects, and gives better cosmetic results.

What this could mean

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

Active substance
intraoperative radiotherapy (radiation given during surgery)
What this could lead to
If successful, this approach could offer a one-time radiation treatment during breast-conserving surgery, potentially reducing the need for weeks of daily radiation afterward.
What could go wrong
This is a single-center study, and results may not apply to all patients. The long-term safety and effectiveness compared to standard radiation are still being evaluated.

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.

Participants

About 620 people

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

Started

Nov 2020

Expected to finish

Nov 2026

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.

Who is studied

The clinical stage of Tis-1N0M0 in patients undergoing breast conserving surgery for early breast cancer

Ages

55 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Age ≥55 years old； 2. Cytology or histology confirmed invasive breast cancer or intraductal carcinoma in situ (DCIS) with a clinical stage of Tis-1N0M0； 3. Patients who are willing to preserve milk and intend to undergo breast-conserving surgery； 4. If invasive breast cancer is confirmed, the surgical margin negative ≥2mm should be met. If DCIS is confirmed, the surgical margin should be negative ≥3mm； 5. ER≥ 30% and PR≥ 1%, HER2 negative； 6. Voluntary participation in this study, signed informed consent, good compliance, cooperate with follow-up. Exclusion Criteria: 1. Simultaneous diagnosis of bilateral or multifocal breast cancer； 2. Previous ipsilateral breast cancer and/or prior chest wall radiation therapy； 3. There are active connective tissue diseases such as scleroderma and systemic lupus erythematosus in the chest； 4. The investigators did not consider the patient suitable for participation in any other conditions of the study.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm ductal breast carcinoma in situ Her2-receptor negative breast cancer invasive breast carcinoma

As listed by the trial registrant

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

Breast cancer HER2-negative breast cancer

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

  • The Fourth Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, China

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