An observational study in Breast Cancer, Breast Reconstruction and Radiotherapy, sponsored by Fudan University. Enrolling by invitation at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Fudan University · Observational
This is a prospective, open-label, controlled clinical trial aiming to investigate the optimal sequencing strategy between immediate autologous tissue breast reconstruction and radiotherapy in breast cancer patients. Eligible participants are female breast cancer patients who have completed neoadjuvant chemotherapy and are scheduled to undergo total mastectomy combined with immediate free abdominal flap (DIEP) breast reconstruction. Participants will be assigned to receive either preoperative radiotherapy followed by reconstruction, or postoperative adjuvant radiotherapy after reconstruction. The primary objectives are to compare surgical safety, oncological safety, patient-reported outcomes (PRO), and aesthetic evaluation between the two radiotherapy sequencing strategies. Secondary objectives include optimizing radiotherapy techniques, radiation doses, and target volume delineation for immediate abdominal free flap reconstruction; exploring the impact of hypofractionated radiotherapy on reconstruction-related complications; investigating the association between multi-omics and immune microenvironment changes and radiotherapy efficacy; and exploring the mechanism by which skin microbiota characteristics affect radiation-induced skin injury through modulation of the skin immune microenvironment. This study hopes to provide clinical evidence for establishing the optimal treatment sequence of immediate breast reconstruction and radiotherapy.
Female patients diagnosed with breast cancer who receive immediate autologous-tissue breast reconstruction after mastectomy, with or without postoperative radiotherapy.
Exclusion Criteria:
Patients receive pre-operative radiotherapy, followed by immediate DIEP flap breast reconstruction surgery. Post-operative rehabilitation and regular follow-up will be performed
Procedure: Immediate DIEP flap breast reconstruction · Radiation: Hypofractionated radiotherapy
Patients undergo immediate DIEP flap breast reconstruction surgery first, followed by post-operative radiotherapy. Post-operative rehabilitation and regular follow-up will be performed.
Procedure: Immediate DIEP flap breast reconstruction · Radiation: Hypofractionated radiotherapy
Autologous breast reconstruction using deep inferior epigastric perforator (DIEP) flap, performed by experienced plastic surgeons, with standard perforator dissection and microsurgical vascular anastomosis.
Standard hypofractionated radiotherapy delivered to the breast region with consistent radiation dose, fractionation protocol and radiotherapy technique for all enrolled patients.
Patient-reported breast satisfaction assessed by BREAST-Q 2.0 scale
Patient-reported outcome (PRO) of breast satisfaction will be measured using the validated Chinese version of BREAST-Q 2.0 questionnaire, including satisfaction with breast appearance, surgical outcome, psychosocial well-being and physical well-being.
Time frame: 12-month after DIEP flap reconstruction surgery
Plan to share: Undecided
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Fudan University