Phase 3 Study Comparing Preoperative Radiation and Immediate Breast Reconstruction Versus Standard Postoperative Radiation and Reconstruction in Women with Breast Cancer

What this Trial Is About

Researchers are investigating whether giving radiation therapy before breast surgery mastectomy combined with immediate breast reconstruction can improve breast appearance and quality of life for women with breast cancer, compared to the current standard treatment where radiation is given after surgery and reconstruction may be delayed. This phase III trial focuses on adult female breast cancer patients who need mastectomy and post-mastectomy radiation therapy PMRT, aiming to assess satisfaction with breasts, quality of life, aesthetic outcomes, treatment duration, safety, and cancer response over time. Participants are randomly assigned to one of two groups. The control group receives mastectomy followed by postoperative radiation therapy and either immediate or delayed breast reconstruction. The experimental group receives preoperative radiation therapy, then mastectomy with immediate breast reconstruction after 2 to 6 weeks. Radiation therapy follows international guidelines for quality and dosing. Systemic treatments are given as usual by doctors and are not changed by this study. Follow-up visits occur at 3 months, 1, 2, 5, and 10 years after the last treatment, with an intermediate visit at 3 months post-radiation for those with delayed reconstruction. During the study, participants complete questionnaires about breast satisfaction and quality of life, and photographs of the breasts are taken and evaluated by experts. Researchers will track adverse events, cancer response in tissue samples, treatment duration, and cancer recurrence. The study aims to provide detailed information on the benefits and risks of changing radiation timing to improve patient outcomes and quality of life over the long term.

Preoperative Radiation Therapy and Immediate Breast Reconstruction