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Can a 3-Week radiation course beat 5 weeks for breast cancer patients with reconstruction?

NCT ID NCT07084519

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether a shorter, higher-dose radiation schedule (3 weeks) is as safe and effective as the standard 5-week schedule for women with high-risk breast cancer who have had a mastectomy and immediate implant reconstruction. The study will enroll 506 women and track reconstruction failure, side effects, and cancer recurrence. The goal is to see if the shorter course can reduce treatment time without increasing complications.

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 (hypofractionated or conventional)
What this could lead to
If successful, a shorter 3-week radiation course could become the new standard, reducing treatment burden and possibly lowering complication rates for women with breast reconstruction.
What could go wrong
This is still a recruiting phase 3 trial; results may show no benefit or higher reconstruction failure with the shorter regimen. Individual outcomes vary.

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 506 people

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

Started

Mar 2026

Expected to finish

Dec 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 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, aged 18-75 years * Karnofsky Performance Status ≥60 * Histopathologically confirmed invasive breast adenocarcinoma * Total mastectomy \[with or without nipple-areolar complex preservation\] + axillary dissection/sentinel lymph node biopsy + implant/expander placement R0 resection with negative margins * pT3 or N2-3 disease; or pT1-2N1 * No distant metastasis * Completed standard neoadjuvant/adjuvant chemotherapy cycles * ≤8 weeks post-chemotherapy or ≤12 weeks post-surgery if no chemotherapy * Signed informed consent Exclusion Criteria: * Prior radiotherapy to chest wall or nodal regions * Pregnancy or lactation * T4 stage disease * Autologous breast reconstruction of the irradiated breast * Pre-radiotherapy local/regional/distant metastasis * Grade ≥3 implant-related adverse events irreversible before radiotherapy * Bilateral breast cancer requiring bilateral radiotherapy * Concurrent/secondary malignancy with disease-free interval \<5 years \[except non-melanoma skin cancer, papillary/follicular thyroid cancer, or cervical carcinoma in situ\] * Active collagen vascular disease, e.g., SLE, scleroderma * Uncontrolled comorbidities: acute cardiovascular disease, substance abuse, or psychiatric disorders

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Conditions

The condition(s) this trial relates to.

breast adenocarcinoma breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer Breast reconstruction Radiation oncology

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

  • Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    RECRUITING

    Beijing, Province, 10000, China

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