Can radiation before or after breast reconstruction improve outcomes?
NCT ID NCT07798466
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
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About 128 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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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.
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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
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
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