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Can a faster radiation course match the standard one after breast reconstruction?

NCT ID NCT07831889

NEW Disease control Sponsor: Tianjin Medical University Cancer Institute and Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compare two radiotherapy schedules for women who had breast reconstruction after mastectomy for breast cancer. One schedule gives larger daily doses over 3 weeks; the other gives smaller daily doses over 5 weeks. The trial checks whether the shorter schedule controls cancer in the breast area as well as the standard one, and how each affects wound healing, side effects, cosmetic results, and quality of life. Blood samples are also studied for markers linked to radiation response.

What this could mean

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

Active substance
radiotherapy given in two different schedules: a shorter high-dose-per-session course or a standard longer course
What this could lead to
If the shorter course works as well as the standard one, women could spend fewer weeks traveling for daily radiation after breast reconstruction.
What could go wrong
The shorter course may not control tumors as well, or it may cause more skin, wound, or implant problems. The trial has not reported results yet.

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 960 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

Apr 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: 1. Female, aged 18 - 75 years 2. Karnofsky score ≥ 60 3. Invasive breast adenocarcinoma confirmed by histopathology 4. Total mastectomy (with or without preservation of nipple-areola complex) + axillary lymph node dissection/ sentinel lymph node biopsy + R0 implantation/expansion placement (negative margins) pT3 or N2-3 stage or pT1-2N1 disease 5. No distant metastasis 6. Completed standard neoadjuvant/adjunctive chemotherapy cycles 7. Signed informed consent form Exclusion Criteria: 1. If a patient has bilateral breast cancer, they will be excluded; those with distant metastasis or metastasis in the supraclavicular or internal mammary lymph nodes; those who have received radiotherapy in the past; those who have had or are currently suffering from malignant tumors, except for non-pigmented skin cancer; those who are pregnant; those with active collagen vascular diseases or other serious diseases, such as alcohol and drug abuse or mental disorders. 2. Patients with severe dysfunction of the heart, liver, or kidneys. 3. Patients with a history of radiotherapy or those who are contraindicated to radiotherapy. 4. Pregnant or lactating women. 5. Patients with severe mental or psychological disorders who cannot fulfill the requirements of the study. 6. Other patients with serious diseases that cannot meet the requirements of the study.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm invasive breast carcinoma

As listed by the trial registrant

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

Breast cancer

How to take part

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  1. 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 ↗

  2. A doctor treating you

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