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Clinical Trials in China / NCT07084519
Recruiting Phase 3

Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction

NCT07084519 · tracked via the Priya Life Science China tracker
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase
Phase 3
Started
2026-03-27
Last updated
2026-06-22

Condition(s) studied

Breast CancerBreast ReconstructionRadiation Oncology

Investigational drug(s) / intervention(s)

hypofractionated radiotherapyconventional fractionated radiotherapy

hypofractionated radiotherapy: 43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks)

conventional fractionated radiotherapy: 50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks

Study 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

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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)

Trial sites (1)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT07084519 on ClinicalTrials.gov ↗ ← All trials in China