Breast Cancer Clinical Trial
Study of Stereotactic Radiotherapy for Breast Cancer
Summary
This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk breast cancer.
Full 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 Criteria
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
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There are 2 Locations for this study
Baltimore Maryland, 21231, United States More Info
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