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Can breast radiation be compressed to one week without hurting cosmetic results?

NCT ID NCT07832279

NEW Disease control Sponsor: Fudan University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing whether a one-week course of partial breast irradiation works as well as a three-week course in women with low-risk early breast cancer who had breast-conserving surgery. The trial enrolls about 818 women and randomly assigns them to either 26 Gy in 5 treatments over one week or 40 Gy in 15 treatments over three weeks, both using intensity-modulated radiation therapy. The main goal is to compare cosmetic outcomes as judged by an independent panel from photographs. The trial also tracks cancer recurrence and overall survival.

What this could mean

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

Active substance
partial breast irradiation using intensity-modulated radiation therapy
What this could lead to
If the shorter course works as well, women with low-risk breast cancer could finish radiation in one week instead of three, with similar cosmetic results and cancer control.
What could go wrong
The one-week schedule may cause worse cosmetic changes or higher recurrence than the three-week schedule. This is a large phase 3 trial, but results are not yet available.

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 818 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2034

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 75 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: * Female patients with an estimated life expectancy greater than 5 years. Meets criteria for either primary invasive breast cancer or pure ductal carcinoma in situ (DCIS). * For invasive breast cancer: Age 40-75 years; Underwent breast-conserving surgery with sentinel lymph node biopsy or axillary lymph node dissection; pT ≤ 3 cm (unicentric/unifocal or total multifocal size ≤ 3 cm); favorable histology (invasive ductal, mucinous, tubular, or solid papillary carcinoma, DCIS component permitted); ER+ and/or PR+; pN0(i- or i+); M0; surgical margins ≥ 2 mm. * For pure DCIS: Age 18-75 years; Underwent breast-conserving surgery with or without sentinel lymph node biopsy; low-to-intermediate nuclear grade; tumor size ≤ 2.5 cm; surgical margins ≥ 3 mm. * Presence of surgical clips or distinct postoperative seroma/tissue changes in the tumor bed allowing precise target delineation. * ECOG performance status 0 or 1. * Eligible for systemic therapy, without prior neoadjuvant systemic therapy. * Able to tolerate radiotherapy procedures and position immobilization. * No contraindications to radiotherapy. * Written informed consent provided. Exclusion Criteria: * Unfavorable histological subtypes (e.g., invasive lobular carcinoma, invasive micropapillary carcinoma). * Positive axillary, internal mammary, or supraclavicular lymph nodes. * Presence of distant metastasis. * Paget's disease of the nipple. * History of prior ipsilateral or contralateral invasive breast cancer or DCIS. * Bilateral breast cancer. * Known germline BRCA1 or BRCA2 mutation. * Prior radiotherapy to the ipsilateral breast, chest wall, or regional lymph nodes. * Active or prior second malignancy (except adequately treated non-melanoma skin cancer). * Severe non-malignant comorbidities (e.g., cardiovascular disease, pulmonary disease, systemic lupus erythematosus, or scleroderma) precluding definitive radiotherapy. * Pregnant or lactating patients. * Inability or unwillingness to comply with scheduled follow-up visits.

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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.

Early-stage 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

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, China

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