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OncoMatch/Clinical Trials/NCT07835139

Hypofractionated vs. Conventionally Fractionated Postmastectomy Radiotherapy After Implant-Based Reconstruction

Official title: Outcomes of Hypofractionated Versus Conventionally Fractionated Radiotherapy After Mastectomy and Implant-Based Reconstruction: A Prospective, Randomized Controlled, Non-Inferiority Trial

Is NCT07835139 recruiting? Yes, currently enrolling (Oct 2026). This NA trial studies non-drug interventions for breast cancer.

NARecruitingFudan UniversityNCT07835139Data as of Oct 2026Location: China

This is a prospective, randomized controlled, non-inferiority clinical trial designed to compare the outcomes of hypofractionated radiotherapy versus conventionally fractionated radiotherapy following mastectomy and implant-based breast reconstruction. The primary objective is to evaluate whether hypofractionated radiotherapy is non-inferior to conventionally fractionated radiotherapy regarding the rate of unplanned reoperation.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Disease stage

Required: Stage C/PT1-3 N0-3 M0

Definite indication for post-mastectomy chest wall ± regional nodal irradiation according to guidelines (typically c/pT1-3 N0-3 M0). T4 disease (including, but not limited to, inflammatory breast cancer, regardless of response to neoadjuvant systemic therapy) [excluded].

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Female only

Prior therapy

Must have received: neoadjuvant or adjuvant systemic therapy — according to guidelines or clinical trial protocols

Received standard neoadjuvant or adjuvant systemic therapy (chemotherapy, endocrine, anti-HER2, or targeted therapy) according to guidelines or clinical trial protocols

Cannot have received: radiotherapy to the ipsilateral chest wall or regional lymph node areas

Prior radiotherapy to the ipsilateral chest wall or regional lymph node areas

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07835139 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior radiotherapy to the ipsilateral chest wall or regional lymph node areas disqualifies patients from enrollment.

What disease stage is eligible?

Stage C/PT1-3 N0-3 M0 is required.

Is this trial open to male patients?

No. This trial enrolls female patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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