Stereotactic Ablative Body Radiotherapy for Early Breast Cancer in Elderly Women Unsuitable for Surgery Receiving Primary Endocrine Therapy

What this Trial Is About

Breast cancer is the most common cancer in women, and its diagnosis is expected to increase in women aged 75 years or older. Surgery is the standard treatment for early breast cancer, but many elderly women are not suitable candidates for surgery due to age-related health conditions. In such cases, hormone therapy alone is often used, although local treatment remains important for controlling the primary tumor. This trial evaluates stereotactic ablative body radiotherapy (SBRT) as a possible local treatment alternative for elderly women with early breast cancer who cannot have surgery and are receiving hormone therapy. SBRT is a non-invasive radiation therapy delivering highly focused, high-dose radiation in a few sessions, usually 3 to 5 fractions. This study investigates three dose levels of SBRT—40 Gy, 42.5 Gy, and 45 Gy—each given in five nonconsecutive once-daily fractions. The radiation dose is precisely targeted to cover the tumor area while sparing healthy tissue. This approach has been effective in other cancers but has limited data in breast cancer, especially for elderly patients who are unsuitable for surgery. Participants will receive SBRT within two months of starting hormone therapy. Researchers will monitor safety by assessing dose-limiting toxicities over six months. They will also evaluate long-term outcomes such as local disease control, clinical response, cosmetic results, progression-free survival, overall survival, and patient-reported health and side effects over five years. The study involves detailed follow-up with clinical assessments and questionnaires to understand the treatment's impact on health and quality of life.

SBRT in Early Breast Cancer in Elderly Women