๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Female patients aged โฅ 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 ยฑ 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 โฅ 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.