Unilateral breast cancer (no synchronous or previous contralateral breast cancer)
Lumpectomy with negative surgical margins by at least 2 mm or re-excision specimen with negative surgical margins by at least 2 mm
Ductal Carcinoma In-Situ
Negative axillary lymph nodes for invasive breast cancer (sentinel node biopsy or standard level I-II dissection with \> 6 nodes removed)
Time interval from final breast surgery to brachytherapy loading less than 8 weeks
At least 2 mm of breast tissue between the skin and the MammoSite® balloon surface(prefer \> 5 mm)
If chemotherapy is planned, it must begin no earlier that 2 weeks following completion of radiation therapy. If chemotherapy is first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation therapy.
Signed study-specific consent form
You may not be if
Invasive lobular histology
Non-epithelial breast malignancies such as sarcoma or lymphoma
Multifocal or multicentric invasive carcinoma
Extensive intraductal component (EIC)
Paget's disease of the nipple
Skin involvement by tumor, regardless of tumor size
Positive axillary lymph nodes
Distant metastases
Collagen vascular disease (scleroderma)
Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females (negative pregnancy test for women of child-bearing age)
Any previously treated or synchronous contralateral breast carcinoma
Patients with psychiatric or addictive disorder that would preclude obtaining informed Consent
Men
Clareo Health | Phase IV Trial to Evaluate Breast Brachytherapy Using the Mammosite-Ml®
