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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

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://www.nsabp.pitt.edu/B39_Information.asp

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