Phase II Trial Comparing Surgery and Radiotherapy Plus Standard Treatment Versus Standard Treatment Alone for Oligometastatic HER2-Positive Breast Cancer

What this Trial Is About

Researchers are evaluating whether adding surgery, locoregional radiation therapy, stereotactic body radiation therapy SBRT, and the usual treatment approach is more effective for treating oligometastatic HER2-positive breast cancer compared to the usual treatment alone. This study focuses on patients with up to 5 metastatic lesions and aims to assess both treatment effectiveness and side effects. It is a randomized Phase II trial sponsored by Memorial Sloan Kettering Cancer Center. Before joining the study, patients will receive first-line systemic therapy following standard guidelines, including drugs such as paclitaxel, trastuzumab, and pertuzumab. After 3 to 12 months without disease progression, participants will be randomly assigned to either continue standard drug therapy or receive additional surgery, locoregional radiation, SBRT, alongside the usual therapy. The surgery may involve lumpectomy or mastectomy, and radiation targets both the breastchest wall area and distant metastatic sites. Participants will be monitored until disease progression or for three years following randomization. Researchers will evaluate progression-free survival over three years as the main outcome. During the study, patients will have regular clinical assessments and imaging to track disease status. The study also follows patients for side effects and overall treatment impact, with all HER2-directed agents used being FDA-approved and given according to standard practice.

A Study of Surgery and Radiotherapy in People With Breast Cancer