Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Begins enrollment this month; Phase 3

Conditions: Breast Reconstruction; Breast Cancer; Radiation Oncology

Treatments: Radiation: conventional fractionated radiotherapy; Radiation: hypofractionated radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07084519

NCC5419

Details and patient eligibility

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)

Enrollment: 190 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

HFRT group

Experimental group

Description:

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

Treatment:

Radiation: hypofractionated radiotherapy

CFRT group

Other group

Description:

50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks

Treatment:

Radiation: conventional fractionated radiotherapy