Breast Cancer Clinical Trial

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Internal Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ

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Summary

RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving internal radiation therapy using a special radiation therapy device may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well internal radiation therapy after lumpectomy works in treating women with ductal carcinoma in situ.

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Full Description

OBJECTIVES:

Primary

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.

Secondary

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.

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Eligibility Criteria

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 lumpectomy
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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

45

Study ID:

NCT00290654

Recruitment Status:

Terminated

Sponsor:

Masonic Cancer Center, University of Minnesota

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There is 1 Location for this study

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Masonic Cancer Center, University of Minnesota
Minneapolis Minnesota, 55455, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

45

Study ID:

NCT00290654

Recruitment Status:

Terminated

Sponsor:


Masonic Cancer Center, University of Minnesota

How clear is this clinincal trial information?

Clinical Trial Resources

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