Hypofractionated vs. standard radiotherapy after mastectomy with implant reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, randomized non-inferiority trial compares hypofractionated radiotherapy to conventionally fractionated radiotherapy in women who have had mastectomy with implant-based reconstruction. The primary outcome is the rate of unplanned reoperation. Eligible participants are adults with unilateral invasive breast cancer who underwent skin-sparing or nipple-sparing mastectomy with reconstruction and standard systemic therapy, and who require post-mastectomy chest wall with or without regional nodal irradiation. The study assesses safety and local-control signals in a real-world clinical setting under standard care conditions. Lead site is Fudan University Shanghai Cancer Center, with collaboration at a single institution location in Shanghai, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female patients aged ≥ 18 years.
* Pathologically confirmed unilateral primary invasive breast cancer.
* Underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with axillary staging (sentinel lymph node biopsy or axillary lymph node dissection).
* Underwent 1-stage (direct-to-implant) or 2-stage (tissue expander) reconstruction, or implant combined with autologous tissue, with prepectoral or subpectoral placement.
* Received standard neoadjuvant or adjuvant systemic therapy (chemotherapy, endocrine, anti-HER2, or targeted therapy) according to guidelines or clinical trial protocols.
* Definite indication for post-mastectomy chest wall ± regional nodal irradiation according to guidelines (typically c/pT1-3 N0-3 M0).
* Interval of at least 6 weeks between reconstruction surgery and the initiation of radiotherapy.
* ECOG performance status 0-1.
* Prior non-breast malignancy permitted if disease-free for \> 5 years with low recurrence risk; prior cervical or colon carcinoma in situ, melanoma in situ, basal cell carcinoma, or squamous cell skin carcinoma permitted regardless of disease-free interval.
* Estimated life expectancy ≥ 10 years.
* Written informed consent provided.

Exclusion Criteria:

* Pregnant or lactating patients.
* Prior history of breast cancer.
* Bilateral breast cancer.
* Prior radiotherapy to the ipsilateral chest wall or regional lymph node areas.
* T4 disease (including, but not limited to, inflammatory breast cancer, regardless of response to neoadjuvant systemic therapy).
* Non-breast malignancy within the past 5 years (except cervical or colon carcinoma in situ, melanoma in situ, basal cell carcinoma, or squamous cell skin carcinoma).
* Severe non-malignant comorbidities (e.g., cardiovascular disease, pulmonary disease, systemic lupus erythematosus, or scleroderma) precluding radiotherapy tolerance or follow-up compliance.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Jinli Ma, MD, PhD
• Email: ma-jinli@outlook.com
• Phone: +86-21-64175590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.