Conformal Ablative Radiotherapy in Older Women (CARMEN) With Breast Cancer Undergoing Non-Operative Management
Trial Parameters
Brief Summary
This phase II study evaluates SABR as non-operative treatment for women aged 65+ with ER-positive, HER2-negative breast cancer ≤5 cm and no lymph node involvement. Eligible patients, including those previously on endocrine therapy, receive 5 SABR treatments, followed by monitoring of quality of life and assessment of treatment-related toxicity.
Eligibility Criteria
Inclusion Criteria: * Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. * Women greater than or equal to age 65 years * Diagnosis of invasive carcinoma of breast undergoing non-operative management * Previously untreated OR previously treated with primary ET or chemotherapy, with either stable or progressive localized disease. * Tumor measuring ≤5 cm (cT1-T2) and clinically node negative * Diagnostic biopsy ER-positive (greater than or equal to 10% ER by immunohistochemistry staining) * Diagnostic biopsy HER2-negative according to ASCO/CAP guidelines (0 or 1+ following IHC staining or proven negative by in-situ hybridization) * Suitable for SABR as deemed by the treating radiation oncologist * Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational