Clinical Trial Data
The MammoSite Radiation Therapy System received FDA clearance in 2002.
The 5-year results of the initial MammoSite clinical trial involving 43 patients are now available, as is data from other studies.
5-Year Clinical Trial Results (N=43)6
- No local recurrences
- 83.3% of patients had good/excellent cosmetic results
- 100% of patients would recommend MammoSite Therapy to a friend or family member
- 100% of patients would use MammoSite Therapy if they had to do it over
The American Society of Breast Surgeons MammoSite Registry Trial13 (N=1440)
44 month follow-up of the first 400 consecutive cases
- Local recurrence rates between 0 -2.65%
- Cancer-specific survival of 100.0%
DCIS: Phase II Clinical Study (12 institutions)14
Fifteen-month mean results (n=100)
- 3.0% local recurrence rate (1 Elsewhere; 2 True Recurrence, Marginal Miss)
- 95% of patients had good/excellent cosmetic results
Prospective randomized trial of whole breast radiation therapy compared to partial breast radiation therapy. Closed to low risk women as of December, 2006.