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