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Recruiting
NCT07084519
Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction
Conditions: Breast Cancer, Breast Reconstruction, Radiation Oncology
Sex: Female
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 506
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Location: 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
Summary
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 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 \
Source: ClinicalTrials.gov (NCT07084519). StuddyBuddy aggregates publicly available trial information.