Overview
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.
- Intervention
HFRT Arm: 43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks). Control Arm: CFRT (50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks). Endpoints Primary: Reconstruction failure rate (e.g., implant removal, capsular contracture)
Eligibility
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
