Breast reconstruction and neoadjuvant radiotherapy (BRENAR) - study protocol for a multicenter, prospective,...

Area of Science:

• Oncology
• Plastic Surgery
• Radiotherapy

Background:

• Post-mastectomy radiotherapy (PMRT) is increasingly used for breast cancer, particularly with lymph node involvement.
• PMRT can lead to complications and poor cosmetic outcomes when combined with immediate breast reconstruction.
• Neoadjuvant radiotherapy (NART) is emerging as a potential alternative to mitigate these issues.

Purpose of the Study:

• To evaluate the safety and efficacy of NART followed by mastectomy and immediate breast reconstruction.
• To assess complication rates, patient-reported outcomes, and cosmetic results.
• To establish a foundation for future randomized controlled trials comparing NART and PMRT.

Main Methods:

• A multicenter, prospective, single-arm pilot study.
• Inclusion of breast cancer patients requiring mastectomy and NART, desiring immediate breast reconstruction (implant-based or autologous).
• Primary endpoint: complications at three months post-reconstruction; secondary endpoints: health-related quality of life (HR-QoL), cosmetic outcomes, and pathological response.

Main Results:

• This section is not available in the provided abstract.

Conclusions:

• Further evidence is needed to confirm NART as a viable alternative to PMRT for immediate breast reconstruction.
• Understanding HR-QoL and cosmetic outcomes is crucial.
• Successful outcomes could lead to a national trial comparing NART and PMRT.