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Could extra radiation after mastectomy keep breast cancer from coming back?

NCT ID NCT04320979

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looks at whether giving extra radiation to lymph nodes behind the breastbone can help prevent breast cancer from returning in high-risk patients. About 2,400 people who had a mastectomy and had cancer in their lymph nodes will take part. The goal is to see if this extra treatment improves how long they live without the cancer coming back.

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

2,400 people

The number who actually took part.

Started

May 2020

Expected to finish

May 2030

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 to 70 years

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: * Eastern Cooperative Oncology Group Performance Status Scale 0-2 * Histologically confirmed invasive breast cancer * Underwent total mastectomy/breast-conserving surgery and axillary dissection(10 or more axillary lymph nodes detected) and negative margins * Patients who had ≥4 positive axillary lymph nodes; or 1-3positive axillary lymph nodes and T3-4; or 1-3positive axillary lymph nodes and T1-2, and score≥3 based on the following high risk factors: age≤40 years(score 1), primary tumor in the inner quadrant (score 1), 2-3 positive axillary lymph nodes (score 1), positive vascular invasion (score 1), re-staged based on eighth Cancer Staging System staging system(IB-IIA score 1, IIB-IIIA score 2); or ypN+ after neoadjuvant chemotherapy * No supraclavicular or internal mammary nodes metastases based on images before system therapy * No distant metastases * Could tolerate radiotherapy * Treated with chemotherapy (anthracycline and/or taxane-based combined chemotherapy, ≥6 cycles) * Anticipated to receive endocrine therapy for 5 years if indicated * Anticipated to receive anti-HER2 therapy for 1 years if indicated * LVEF≥50% based on echocardiogram * Willing to follow up * Written,informed consent Exclusion Criteria: * Simultaneous bilateral breast cancer * Sentinel lymph node biopsy only without axillary dissection * Had received internal mammary node dissection * No imaging assessment of the internal mammary nodal before system therapy * One-stage breast reconstruction * Severe cardiac insufficiency; myocardial infarction or uncorrected unstable arrhythmia or uncorrected unstable angina in the last 3 months; pericardial disease * Had history of chest wall or supraclavicular radiotherapy * Had simultaneous or previous secondary malignancies, except for non-malignant melanoma skin cancer, papillary thyroid / follicular carcinoma, cervical carcinoma in situ, contralateral non-invasive breast cancer

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, 100021, China

More trials for these conditions

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