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Enrolling by invitation

NCT Number: NCT07798466

Immediate Autologous Tissue Breast Reconstruction and Radiotherapy Strategy After Breast Cancer Surgery

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.

Enrolling by invitation

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate DIEP flap breast reconstruction

Procedure

Autologous breast reconstruction using deep inferior epigastric perforator (DIEP) flap, performed by experienced plastic surgeons, with standard perforator dissection and microsurgical vascular anastomosis.

Hypofractionated radiotherapy

Radiation

Standard hypofractionated radiotherapy delivered to the breast region with consistent radiation dose, fractionation protocol and radiotherapy technique for all enrolled patients.

Primary outcomes

  1. Patient-reported breast satisfaction assessed by BREAST-Q 2.0 scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Clinical Study of Immediate Autologous Tissue Breast Reconstruction and Radiotherapy-Related Diagnosis-Treatment Strategy After Breast Cancer Surgery

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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