Phase II Study of Proton Therapy for Partial Breast Irradiation in Women with Early Stage Breast Cancer

What this Trial Is About

Researchers are evaluating proton radiation therapy as a treatment option for women with early stage breast cancer. This study aims to compare the effects, both positive and negative, of proton therapy against traditional radiation methods. The focus is on whether limiting radiation to the original tumor area, rather than the whole breast, can reduce side effects and improve convenience and cost without compromising treatment effectiveness. The study involves delivering proton radiotherapy at a dose of 4.0 Gy RBE per session across 10 sessions, totaling 40 Gy RBE. This partial breast irradiation approach targets the tumor area specifically, potentially minimizing radiation exposure to surrounding healthy breast tissue. The treatment is non-invasive and uses advanced imaging guidance, with some patients possibly requiring markers placed in the surgical area to assist with accurate targeting. Participants start treatment within 12 weeks of surgery or 8 weeks after chemotherapy completion. Participants will be closely monitored through regular assessments every six months, including evaluations of breast cancer recurrence, treatment-related toxicity, dosimetry related to breast size, quality of life, and overall survival, with key outcomes reviewed at three years. Safety and effectiveness are continuously assessed, and participants health status will be followed long-term. The total duration of involvement varies as lifetime follow-up is planned for toxicity and quality of life measures.

Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer