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

NCT07798466 | Enrolling By Invitation

• 1 other identifier: CAPPELALA
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Reconstruction; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  12-month after DIEP flap reconstruction surgery

Study Arms (2)

Pre-operative Radiotherapy Group

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

Post-operative Radiotherapy Group

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

Interventions

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.

Post-operative Radiotherapy Group; Pre-operative Radiotherapy Group

Hypofractionated radiotherapy RADIATION

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

Post-operative Radiotherapy Group; Pre-operative Radiotherapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients diagnosed with breast cancer who receive immediate autologous-tissue breast reconstruction after mastectomy, with or without postoperative radiotherapy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician,Professor

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: September 1, 2025
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 1, 2026

Record last verified: 2026-08

Locations

CN (1)