Clinical Trial Data
The MammoSite Radiation Therapy System received FDA clearance in 2002.
The 5-year results of the initial MammoSite clinical trial7 involving 43 patients are now available, as is data from other studies.
5-Year Clinical Trial Data7 Show:
No local recurrences8
82% of patients had good/excellent cosmetic results9
100% of patients would recommend MammoSite Therapy to a friend or family member1
100% of patients would use MammoSite Therapy again if they had to do it over1
DCIS: Phase II Clinical Study (12 institutions) 15
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
NSABP-39
Prospective randomized trial of whole breast radiation therapy compared to partial breast radiation therapy.
Closed to low risk women as of December, 2006.
http://foundation.nsabp.org/schmeas/B39_info.htm