Study of Neoadjuvant Radiotherapy Before Mastectomy with Immediate Breast Reconstruction in Breast Cancer Evaluating Post-Surgical Complications and Outcomes

What this Trial Is About

The trial investigates the effects of neoadjuvant radiotherapy NART on acute post-surgical complications following mastectomy and immediate breast reconstruction in women with breast cancer. Researchers aim to determine whether NART can reduce complications compared to the standard postmastectomy radiotherapy PMRT, which is associated with higher complication rates and poorer cosmetic outcomes. This pilot study focuses on assessing the safety of NART in this setting, with future studies planned to evaluate long-term quality of life and cancer outcomes if complication rates are acceptable. Participants will receive neoadjuvant radiotherapy consisting of 15 sessions of 2.67 Gy each, delivered five times per week, starting 6 to 8 weeks after the last chemotherapy treatment if applicable. Approximately 2 to 6 weeks after completing radiotherapy, patients will undergo mastectomy with immediate breast reconstruction using either a silicone implant or autologous tissue, commonly the Deep Inferior Epigastric Perforator DIEP flap. This single-arm interventional pilot study will include twenty female breast cancer patients who require mastectomy and radiotherapy and desire immediate reconstruction. During the study, participants will be monitored for acute post-surgical complications up to three months after their latest reconstructive surgery. Researchers will assess treatment-related adverse events, patient-reported satisfaction with breasts and well-being using the BREAST-Q questionnaire, and cosmetic results as rated by physicians. Additional evaluations include the timing of any adjuvant therapy and pathological response in the mastectomy specimen. Participants will also complete questionnaires about cosmetic outcomes and quality of life, requiring about 15 to 30 minutes each. The total study duration includes surgery, radiotherapy, and follow-up assessments within a few months.

Breast Reconstruction and Neoadjuvant Radiotherapy