Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction (NCT07084519) | Clinical Trial Compass
RecruitingPhase 3
Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction
China506 participantsStarted 2026-03-27
Plain-language 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)
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reconstruction Failure Rate
Timeframe: 2 year
Trial details
NCT IDNCT07084519
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences