Breast Cancer, Breast Reconstruction, Radiation Oncology
Conditions
Keywords
breast cancer, prosthetic breast reconstruction, hypofractionated radiotherapy
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)
Interventions
RADIATIONhypofractionated radiotherapy
43.5 Gy in 15 fractions (2.9 Gy/fraction, 3 weeks)
50 Gy in 25 fractions, 2 Gy/fraction, 5 weeks
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reconstruction Failure Rate | 2 year | implant removal, capsular contracture ≥ Baker grade III |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 BREAST-Q (Breast Reconstruction Module), Version 2.0 | Baseline, 6 months, and 12 months after treatment | The BREAST-Q (Breast Reconstruction Module), Version 2.0 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. |
Countries
China
Contacts
CONTACTXuran Zhao, MD
CONTACTYirui Zhai, MD
Outcome results
None listed