Recruiting
Hypofractionated vs. Conventionally Fractionated Postmastectomy Radiotherapy After Implant-Based Reconstruction
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.
ClinicalTrials.gov IDNCT07835139
PhaseNA
Enrollment534
SponsorFudan University
Age18 Years and older
SexFEMALE
About this study
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.
Interventions
- Radiation: ConvRT — 50Gy/25Fx, 2Gy/Fx, once daily
- Radiation: HypoRT — 42.56Gy/16Fx, 2.66Gy/Fx, once daily
Primary outcomes
- The rate of unplanned reoperation (3 years)
Eligibility information
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.
Study locations
- Fudan University Shanghai Cancer Center, Shanghai, 200032 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-21.