This study investigates the safety and efficacy of hypofractionated radiotherapy (HFRT) versus conventional fractionated radiotherapy (CFRT) in breast cancer patients undergoing total mastectomy with prosthetic reconstruction.
Study Design Population: Patients with high-risk breast cancer after mastectomy and immediate implant reconstruction.
Inclusion Criteria:
* Female, aged 18-75 years
* Karnofsky Performance Status ≥60
* Histopathologically confirmed invasive breast adenocarcinoma
* Total mastectomy \[with or without nipple-areolar complex preservation\] + axillary dissection/sentinel lymph node biopsy + implant/expander placement R0 resection with negative margins
* pT3 or N2-3 disease; or pT1-2N1
* No distant metastasis
* Completed standard neoadjuvant/adjuvant chemotherapy cycles
* ≤8 weeks post-chemotherapy or ≤12 weeks post-surgery if no chemotherapy
* Signed informed consent
Exclusion Criteria:
* Prior radiotherapy to chest wall or nodal regions
* Pregnancy or lactation
* T4 stage disease
* Autologous breast reconstruction of the irradiated breast
* Pre-radiotherapy local/regional/distant metastasis
* Grade ≥3 implant-related adverse events irreversible before radiotherapy
* Bilateral breast cancer requiring bilateral radiotherapy
* Concurrent/secondary malignancy with disease-free interval \<5 years \[except non-melanoma skin cancer, papillary/follicular thyroid cancer, or cervical carcinoma in situ\]
* Active collagen vascular disease, e.g., SLE, scleroderma
* Uncontrolled comorbidities: acute cardiovascular disease, substance abuse, or psychiatric disorders
Primary outcome measure(s)
Reconstruction Failure Rate — 2 year implant removal, capsular contracture ≥ Baker grade III
Trial sites (1)
Facility
City
Region
Status
Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
Province
Recruiting
More Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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