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Can a gene test spare breast cancer patients from extra radiation?

NCT ID NCT04517266

Disease control Sponsor: Ruijin 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial is testing whether a genomic test can identify early-stage breast cancer patients who might safely skip radiation to the internal mammary lymph nodes. Participants have 1-3 positive lymph nodes and are considered at intermediate risk. Half will receive standard radiation to the chest and supraclavicular area, while the other half will also receive internal mammary irradiation. The goal is to see if skipping this extra radiation does not increase the risk of cancer returning within two years.

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 (internal mammary irradiation vs. omission)
What this could lead to
If successful, this could personalize breast cancer treatment, sparing some women from unnecessary radiation and its side effects.
What could go wrong
The trial is relatively small and early, and the long-term benefits of skipping this radiation are uncertain. There is a risk of increased cancer recurrence.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 214 people

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

Started

Mar 2021

Expected to finish

Oct 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 80 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: * • Histologically confirmed invasive breast cancer * Underwent radical surgery with either mastectomy or breast conserving surgery and axillary lymph node dissection (ALND) * The number of positive lymph node should be 1-3 (N1). * Clinical high risk breast cancer (≥2 clinical risk factors) * Aged 18-80 years old * ECOG performance status ≤2 (Karnofsky ≥70%) Anticipative overall survival \>5 years Pathologically surgical margin \>2mm ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2) and Ki67 testing can be performed on the primary breast tumor Women of child-bearing potential must agree to use adequate contraception for up to 1 month before study treatment and the duration of study participation Ability to understand and willingness to participate the research and sign the consent form Exclusion Criteria: * • Axillary dissection of less than 10 lymph nodes * Pathologically positive ipsilateral supraclavicular lymph node * Pathologically or radiologically confirmed involvement of ipsilateral internal mammary lymph nodes * Pregnant or lactating women * Treated with breast reconstruction surgery * Severe non-neoplastic medical comorbidities * History of non-breast malignancy within 5 years with the exception of lobular carcinoma in situ, basal cell carcinoma of the skin, carcinoma in situ of skin and carcinoma in situ of the cervix * simultaneous contralateral breast cancer * Previous radiotherapy to the neck, chest and/or ipsilateral axillary region * Active collagen vascular disease * Definitive pathological or radiologic evidence of distant metastatic disease * Primary T4 tumor * Interval between radical surgery (mastectomy or breast conserving surgery) and radiotherapy was more than 12 weeks or interval between last dose of adjuvant chemotherapy and radiotherapy was more than 8 weeks

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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

  • Ruijin Hospital, Shanghai jiaotong univestigy school of medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200025, China

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