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Clinical Data

The final analysis of the American Society of Breast Surgeons (ASBS) MammoSite Breast Brachytherapy Registry Trial (N=1440) confirmed the excellent results of treatment efficacy, cosmesis and toxicity. The study also concluded these results are similar and compared favorably with other forms of APBI and whole-breast irradiation with similar follow-up period. 

  • Excellent/good cosmesis was observed in:
    • 91.3% of patients at 5 years
    • 90.5% of patients at 6 years
    • 90.6% of patients at 7 years
  • Overall rate of fat necrosis was 2.5% with an infection rate of 9.6% and few late toxicity events beyond 2 years
  • Overall symptomatic seroma rate was 13.4% and 0.6% beyond 2 years
  • Ipsilateral breast tumor recurrence (IBTR) was developed in 41 cases (2.8%) for a 5-year actuarial rate of 3.8 % (3.7% for IBC and 4.1% for DCIS)

The Five-year Results of the Initial Clinical Trial of MammoSite Balloon Brachytherapy for Partial Breast Irradiation in Early-Stage Breast Cancer involving 43 patients5 shows:

  • No local recurrences
  • 83.3% of patients had good/excellent cosmetic results
  • 100% of patients would recommend Hologic 5-Day targeted radiation therapy to a friend or family member
  • 100% of patients would use Hologic 5-Day targeted radiation therapy if they had to do it over