Can radiation before or after breast reconstruction improve outcomes?

NCT ID NCT07798466

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
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial studies women with breast cancer who need a mastectomy, radiation, and immediate breast reconstruction using their own abdominal tissue (DIEP flap). The goal is to compare giving radiation before surgery versus after surgery. Researchers will measure patient satisfaction, surgical safety, and cosmetic results to find the best sequence.

What this could mean

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

Active substance
Immediate DIEP flap breast reconstruction and hypofractionated radiotherapy
What this could lead to
If successful, this trial could identify the best order for radiation and breast reconstruction, improving patient satisfaction and reducing complications.
What could go wrong
This is a single-center trial with 128 participants, so results may not apply broadly. Radiation timing could affect reconstruction outcomes, and the study is not designed to prove long-term survival benefits.

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.

Participants

About 128 people

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

Started

Sep 2025

Expected to finish

Nov 2026

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.

Who is studied

Female patients diagnosed with breast cancer who receive immediate autologous-tissue breast reconstruction after mastectomy, with or without postoperative radiotherapy.

Ages

18 years and older

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: * Aged 18 years or older * Female * Pathologically confirmed invasive breast cancer prior to surgery * Planned to receive neoadjuvant chemotherapy * No clinical or radiographic evidence of distant metastasis * Meets indication for postmastectomy radiotherapy (PMRT) * Willing to undergo immediate autologous free flap breast reconstruction using abdominal tissue * Able and willing to provide written informed consent Exclusion Criteria: * Completed neoadjuvant chemotherapy with no current indication for adjuvant radiotherapy * Disease progression during neoadjuvant chemotherapy, failing to complete the planned regimen * Pregnant or lactating women * History of diabetes mellitus * History of heavy smoking

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

    Shanghai, Shanghai Municipality, 200032, China

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