Study of Stereotactic Radiotherapy for Breast Cancer
Study of Stereotactic Radiotherapy for Breast Cancer
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