This study will evaluate the local control rate, cosmetic results, and complication rates of
breast brachytherapy delivered using the MammoSite-ML® when used as the sole method of
radiation therapy or as a boost technique for patients with stage I-II carcinoma of the
breast (< 3 cm), (non-lobular histology) treated with lumpectomy with histologically negative
surgical margins by at least 2 mm, negative axillary lymph nodes, and DCIS.
- For selected patients with stage I breast carcinoma and Ductal Carcinoma In Situ (DCIS),
radiation therapy delivered with brachytherapy alone using the MammoSite-ML® is
technically feasible and reproducible with acceptable complication rates.
- Cosmetic results after brachytherapy will be similar to that obtained after traditional
whole breast external beam radiation therapy.
- Local tumor control rate in the breast after brachytherapy will be similar to that of
conventional external beam radiation therapy, with less inconvenience and potentially
less cost to the patient, given the selection criteria which minimize the risk of
clinically significant multicentric or extensive residual carcinoma following