Hypofractionated radiotherapy after prosthetic breast reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 interventional trial comparing hypofractionated radiotherapy (HFRT) to conventional fractionated radiotherapy (CFRT) in women with high-risk breast cancer who have undergone total mastectomy with immediate prosthetic reconstruction. Participants are randomized to receive HFRT: 43.5 Gy in 15 fractions over three weeks, or CFRT: 50 Gy in 25 fractions over five weeks. The primary endpoint is the reconstruction failure rate, including implant removal and capsular contracture. Eligible patients are adults with good performance status who completed standard chemotherapy and meet specific tumor and surgical criteria, with no distant metastasis or prior chest wall radiotherapy. The study is conducted at the Cancer Institute and Hospital, Chinese Academy of Medical Sciences, in Beijing.

Why it matters

Who can join: the full rules

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

Where it's running

• 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 Recruiting

Study contacts

• Study coordinator: Xuran Zhao, MD
• Email: 923791362@qq.com
• Phone: 86-13661135602

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.