Hypofractionated vs. Conventionally Fractionated Postmastectomy Radiotherapy After Implant-Based Reconstruction

This is a prospective, randomized controlled, non-inferiority clinical trial designed to compare the outcomes of hypofractionated radiotherapy versus conventionally fractionated radiotherapy following mastectomy and implant-based breast reconstruction. The primary objective is to evaluate whether hypofractionated radiotherapy is non-inferior to conventionally fractionated radiotherapy regarding the rate of unplanned reoperation.

Trial Details

NCT ID
NCT07835139
Phase
NA
Sponsor
Fudan University
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • ConvRT
  • HypoRT
Locations (sample)
  • Shanghai, China|31.22222,121.45806

Key Eligibility Criteria

  • Female patients aged ≥ 18 years.
  • Pathologically confirmed unilateral primary invasive breast cancer.
  • Underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with axillary staging (sentinel lymph node biopsy or axillary lymph node dissection).
  • Underwent 1-stage (direct-to-implant) or 2-stage (tissue expander) reconstruction, or implant combined with autologous tissue, with prepectoral or …

For full eligibility, visit ClinicalTrials.gov.

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