Breast Cancer, Breast Reconstruction, Radiotherapy
Conditions
Brief summary
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.
Interventions
PROCEDUREImmediate DIEP flap breast reconstruction
Autologous breast reconstruction using deep inferior epigastric perforator (DIEP) flap, performed by experienced plastic surgeons, with standard perforator dissection and microsurgical vascular anastomosis.
RADIATIONHypofractionated radiotherapy
Standard hypofractionated radiotherapy delivered to the breast region with consistent radiation dose, fractionation protocol and radiotherapy technique for all enrolled patients.
Sponsors
Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older * Female * Pathologically confirmed invasive breast cancer prior to surgery * Planned to receive neoadjuvant chemotherapy * No clinical or radiographic evidence of distant metastasis * Meets indication for postmastectomy radiotherapy (PMRT) * Willing to undergo immediate autologous free flap breast reconstruction using abdominal tissue * Able and willing to provide written informed consent
Exclusion criteria
* Completed neoadjuvant chemotherapy with no current indication for adjuvant radiotherapy * Disease progression during neoadjuvant chemotherapy, failing to complete the planned regimen * Pregnant or lactating women * History of diabetes mellitus * History of heavy smoking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported breast satisfaction assessed by BREAST-Q 2.0 scale | 12-month after DIEP flap reconstruction surgery | 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. |
Countries
China
Outcome results
None listed