Breast Cancer Clinical Trial
Post Market Study Using the Xoft Axxent System
Summary
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.
Full Description
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System for the delivery of radiation therapy as part of breast conserving therapy in women with resected, early stage breast cancer.
Eligibility Criteria
Inclusion Criteria:
Age >50 years
Tumor with Tis, T1, N0, M0 - (AJC Classification)
Invasive ductal carcinoma or ductal carcinoma in situ
Negative microscopic surgical margins of at least 1mm in all directions
Adequate skin spacing between balloon surface and surface of the skin - (> 7mm)
Exclusion Criteria:
Pregnancy or breast-feeding - (During the treatment portion of the study, sexually active women of childbearing age will be asked to use pregnancy prevention)
Scleroderma, systemic sclerosis and active lupus
Infiltrating lobular histology
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There are 10 Locations for this study
San Mateo California, 94401, United States
Marietta Georgia, 30060, United States
Chicago Illinois, 60612, United States
Evergreen Park Illinois, 60805, United States
Silver Spring Maryland, 20910, United States
New York New York, 10003, United States
White Plains New York, 10601, United States
Oklahoma City Oklahoma, 73104, United States
Providence Rhode Island, 02903, United States
Seattle Washington, 98104, United States
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