Study of Stereotactic Radiotherapy for Breast Cancer

A Phase II Study of Preoperative Single Fraction Stereotactic Body Radiotherapy to the Intact Breast in Early Stage Low Risk Breast Cancer: Analysis of Radiation Response

This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk breast cancer.

This is a single arm phase II study design, evaluating the pathologic response (primary endpoint) as well as toxicity, cosmetic outcome, quality of life, and translational correlates (secondary endpoints) to pre-operative stereotactic body radiotherapy (SBRT) to intact breast tumors in patients with hormone-receptor positive early stage breast cancer.

Inclusion Criteria:

• Female sex
• Age > or = to 50 years of age
• Invasive ductal carcinoma
• Clinically and radiographically T1 tumor
• Clinically node negative
• Clearly demarcated tumor on magnetic resonance imaging (MRI), as determined by treating physician (MRI may be done after enrollment if not done prior)
• Planning breast conserving surgery including sentinel node biopsy
• ≥10% expression of ER and/or PR
• HER2- using the current College of American Pathologists guidelines
• Post-menopausal
• Willing and able to provide informed consent

Exclusion Criteria:

• Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma
• Pure DCIS without invasive cancer
• Patients who have received or will be receiving neoadjuvant systemic therapy, endocrine therapy, or targeted agents
• Breast implant in the involved breast unless the implant will be removed prior to initiation of study treatment
• Positive pregnancy test
• Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement.
• Unable to meet dosimetric constraints due to tumor location and/or patient anatomy
• Planning mastectomy
• Unable to tolerate prone positioning