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Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction

RecruitingPhase 3

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Conditions: Breast Cancer, Breast Reconstruction, Radiation Oncology

Interventions: hypofractionated radiotherapy, conventional fractionated radiotherapy

Countries: China

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 overview

Sex: FEMALE

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Beijing, Province, China