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Tailored radiation may spare breast cancer patients from arm swelling

NCT ID NCT06583655

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study is testing whether giving radiation therapy tailored to each patient's risk level can reduce arm swelling (lymphedema) while still controlling cancer in women with early-stage breast cancer that has spread to a sentinel lymph node. Participants receive either whole breast radiation alone or radiation to the breast plus regional lymph nodes, depending on clinical and genomic risk assessments. The goal is to see if a personalized approach can avoid the need for more extensive surgery and minimize side effects without increasing the chance of cancer returning.

What this could mean

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

Active substance
Individualized regional node irradiation (radiation therapy)
What this could lead to
If successful, this could lead to a more personalized approach to radiation after breast cancer surgery, reducing arm swelling without compromising cancer control.
What could go wrong
The trial is early and may not show a clear benefit. Radiation can still cause side effects, and the optimal radiation fields remain uncertain.

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 205 people

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

Started

Oct 2024

Expected to finish

Apr 2028

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: * 1\. Histologically confirmed invasive breast cancer; 2. Age between 18 and 80 years; 3. cN0 breast cancer underwent radical surgery combined with Sentinel Lymph Node Dissection (SLND) alone with SLND positive or SLND and axillary lymph node dissection (ALND) with positive lymph node metastasis; 4. for SLND alone cohort, the regional lymph node irradiation area was determined according to the clinical risk model and genomic risk model assessment; 5. Ability to understand and willingness to participate the research and sign the consent form Exclusion Criteria: * • Pathologically positive ipsilateral supraclavicular lymph node * Pathologically or radiologically confirmed involvement of ipsilateral internal mammary lymph nodes; * Pregnant or lactating women; * Insulin dependent diabetes; * 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; * patients have simultaneous contralateral breast cancer; * clinical diagnosis of distant metastatic disease; * Previous radiotherapy to the neck, chest and/or ipsilateral axillary region

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Conditions

The condition(s) this trial relates to.

invasive breast carcinoma

As listed by the trial registrant

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

Breast cancer invasive

Contacts and locations

Locations

  • Ruijin hospital, Shanghai jiaotong university school of medicine

    Shanghai, China, 200025, China

More trials for these conditions

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