Twin Cities Brachytherapy Study for Ductal Carcinoma in Situ A Phase II Trial
- Determine the ipsilateral breast tumor recurrence rate in women with ductal carcinoma
in situ undergoing lumpectomy followed by brachytherapy using the MammoSite^® Radiation
- Determine the early and late complication rates and cosmetic outcome in these patients
OUTLINE: Patients undergo lumpectomy. Patients with negative tumor margins* (no ink on
tumor) undergo placement of the MammoSite^® Radiation Therapy System at the time of
lumpectomy or within 4 weeks after surgery.
NOTE: *If positive margins are present, the surgeon may elect to resect the positive margins
and then insert a new MammoSite® device if all other eligibility criteria are met.
Beginning 2-5 days after placement of the MammoSite^®, patients undergo brachytherapy
through the MammoSite^® twice daily for 5 days (a total of 10 fractions).
After completion of study treatment, patients are followed periodically for ≥ 5 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Ipsilateral breast tumor recurrence rate
Month 6 and Yearly thereafter
Todd M. Tuttle, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center, University of Minnesota||Minneapolis, Minnesota 55455|