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Could thousands of breast cancer patients skip extra radiation?

NCT ID NCT07385365

Disease control Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial will test if women with intermediate-risk breast cancer can safely skip radiation to the lymph nodes after surgery. About 3,142 participants will be randomly assigned to receive either standard radiation to the breast or chest wall plus lymph nodes, or radiation only to the breast or chest wall (or no radiation after mastectomy). The goal is to see if skipping lymph node radiation leads to similar cancer-free survival with fewer side effects.

What this could mean

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

Active substance
radiation therapy
What this could lead to
If successful, this could show that many intermediate-risk breast cancer patients can safely avoid extra radiation to the lymph nodes, reducing side effects without harming survival.
What could go wrong
This is a large phase 3 trial, but it's not yet recruiting. The benefit of skipping radiation may be small, and there is a risk of higher cancer recurrence in the non-radiation group.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 3,142 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2042

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

Female participants only

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: * Female patients aged 18 or above * Undergo breast-conserving surgery or total mastectomy and axillary lymph node dissection or sentinel lymph node biopsy * The surgical margin was negative * Tumor stage:Patients who receive direct surgery : pT1-2N1M0, with at least one lymph node having macrometastasis and a tumor risk score of 0-2.For those who underwent surgery after neoadjuvant chemotherapy: cT1-2N1-2M0→ypT0-2N0M0 (cN+ with pathological confirmation), neoadjuvant Chemotherapy for ≥6 cycles. Exclusion Criteria: * distant metastasis * metastasis of ipsilateral internal mammary, supraclavicular or subclavian lymph nodes * Had received chest radiotherapy in the past * Bilateral breast cancer * Pregnancy or lactation period * Other malignant tumors in the past or at the same time, and the tumor-free survival time is less than 5 years (excluding non-malignant melanoma skin cancer, papillary thyroid carcinoma/follicular carcinoma, cervical carcinoma in situ)

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

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

  • Cancer Hospital,Chinese Academy od Medical Sciences

    Beijing, Beijing Municipality, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.