Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer; Breast Reconstruction; Radiation Oncology

• Registration Number: NCT07084519
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief 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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-07-02
• Study First Submitted QC: 2025-07-22
• Last Update Submitted: 2025-07-22
• Study First Posted: 2025-07-24
• Last Update Posted: 2025-07-24
• Study Start: 2025-08-10
• Primary Completion: 2025-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reconstruction Failure Rate	2 year	implant removal, capsular contracture ≥ Baker grade III

Secondary Outcome Measures

Name	Time	Method
Other Implant-Related Adverse Events	2 year	infection, skin necrosis, implant exposure
Radiation-Related Toxicities	2 year	grade ≥3 dermatitis, pneumonitis, lymphedema
DFS	5 year	Disease-Free Survival
OS	5 year	Overall Survival
LRR	5 year	Locoregional Recurrence Rate
DM	5 year	Distant Metastasis Rate
Cosmetic Outcome Assessed by Harvard Breast Cosmesis Scale (Physician-Rated)	1 year	Physicians will assess cosmetic outcome using the Harvard Breast Cosmesis Scale.; Unit of Measure: Score on Harvard Breast Cosmesis Scale Scale Information: Score range from 1 (Excellent) to 4 (Poor). Higher scores indicate worse cosmetic outcomes.
Patient-Reported Cosmetic Outcome	1 year	Description: Patients will self-assess cosmetic outcome using a 4-point Likert scale.; Unit of Measure: Score on 4-point Likert scale. Scale Information: Score range from 1 (Excellent) to 4 (Poor). Higher scores indicate worse perceived outcome.
Quality of Life Assessed by EORTC QLQ-C30 Global Health Status Score	Baseline, 6 months, and 12 months after treatment	The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) will be used to evaluate patients' global health status and overall quality of life.; Unit of Measure: Score on a scale Scale Information: Score ranges from 0 to 100; higher scores indicate better global health status.
Quality of Life Assessed by EORTC QLQ-BR23 Breast Cancer Module	Baseline, 6 months, and 12 months after treatment	The EORTC Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR23) will be used to assess breast cancer-specific quality of life.; Unit of Measure: Score on a scale Scale Information: Score ranges from 0 to 100. For functional scales, higher scores indicate better function; for symptom scales, higher scores indicate worse symptoms.

Trial Locations

Locations (1)

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