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Twin Cities Brachytherapy Study for Ductal Carcinoma in Situ A Phase II Trial

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

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
Therapy System.


- Determine the early and late complication rates and cosmetic outcome in these patients
after treatment.

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.

Inclusion Criteria:

- Ductal carcinoma in situ (DCIS) confirmed by excisional or needle biopsy

- Size: < 3 cm on mammogram

- Unicentric disease

- Ability to place MammoSite device at time of lumpectomy or within 4 weeks of

- Patient Age: ≥ 18 years, no upper limit

- Life expectancy > 5 years

Exclusion Criteria:

- Prior history of cancer other than basal or squamous cell skin cancer or in situ
cancer of the cervix

- Pregnant or breast feeding

- Multicentric disease

- Diagnosis of collagen vascular diseases, such as systemic lupus erythematosis,
scleroderma, or dermatomyositis

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Ipsilateral breast tumor recurrence rate

Outcome Time Frame:

Month 6 and Yearly thereafter

Safety Issue:


Principal Investigator

Todd M. Tuttle, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

December 2002

Completion Date:

June 2012

Related Keywords:

  • Breast Cancer
  • ductal breast carcinoma in situ
  • breast cancer in situ
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal



Masonic Cancer Center, University of Minnesota Minneapolis, Minnesota  55455