Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction
Recruiting · NCT07084519 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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)
Who can take part
Age range
18 Years to 75 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- 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, China