Feasibility of Preoperative Radiotherapy in T3 and T4 Breast Cancer Patients Who Respond to Neoadjuvant Chemotherapy to Allow Immediate Reconstruction: a Prospective Study

What this Trial Is About

Researchers are evaluating an alternative treatment approach for people with T4 breast cancer that involves giving radiotherapy before mastectomy (preoperative radiotherapy) followed by immediate autologous reconstruction surgery. This immediate reconstruction uses tissue from another part of the body to recreate the breast right after mastectomy, differing from the standard reconstruction which happens later. The study aims to find out if this new approach is feasible and to compare its safety with the current standard treatment. Participants will first receive neoadjuvant radiotherapy after a biopsy guided by MRI to the cancer area following chemotherapy. Two to six weeks after completing radiotherapy, they will undergo a unilateral total mastectomy with axillary lymph node dissection, removing all involved breast skin without skin-sparing mastectomy. At the same time, they will have immediate autologous breast reconstruction using tissue flaps such as DIEP, ms-TRAM, or latissimus dorsi flap. During the study, researchers will monitor participants for wound complications over five years to compare outcomes between this new treatment and the standard care. Participants will be assessed through imaging, clinical examinations, and surgical evaluations. The study is led by Memorial Sloan Kettering Cancer Center and is a phase 1 trial focused on safety and feasibility in females aged 18 and older with biopsy-proven invasive breast cancer responding to chemotherapy.

A Study of an Alternative Treatment Approach (Preoperative Radiotherapy, Then Mastectomy, Then Immediate Reconstruction Surgery) in People With T4 Breast Cancer