Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction
Recruiting
Phase 3
Interventional Study
Breast Cancer
Breast Reconstruction
Radiation Oncology
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 506 (estimated)
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
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 R…
Contacts