MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ

Completed · Phase 2

Conditions studied: DCIS

In brief

This study has been designed to compile information on the efficacy of the MammoSite RTS providing sole radiation therapy for patients with pure DCIS.

Key facts

Study ID

NCT00586326

Run by

Hologic, Inc.

People needed

133

Starts

2003-08-01

Expected to finish

2011-04-01

Last updated by the study team

2012-11-06

Who can join

Age: 45 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Pre-Surgery:
• Unicentric pure DCIS
• Lesions should have a greatest dimension of 3 cm or less as determined by pre-surgery mammography and MRI
• Post-Surgery:
• Negative histological margins confirmed prior to beginning radiation therapy.
• Margins are positive if there is tumor at the inked margin.
• Classified as low (NG1), intermediate (NG2) or high (NG3) nuclear grade DCIS, using the Philadelphia Consensus Conference Guidelines are eligible
• Clinically node negative

You may not qualify if…

• Distance from the balloon surface to the surface of the skin < 5mm as determined by CT imaging.
• Distant metastases.
• Invasive or in-situ lobular carcinoma (post-surgery assessment).
• Nonepithelial breast malignancies such as sarcoma or lymphoma.
• DCIS that is multicentric in the ipsilateral breast.
• Pregnant or lactating.
• Prior non-hormonal therapy for the present breast cancer, including radiation therapy and/or chemotherapy.
• Collagen vascular diseases
• Coexisting medical conditions with life expectancy < 2 years.
• Serious psychiatric or addictive disorder
• Previously treated contralateral breast carcinoma
• Synchronous bilateral breast carcinoma.
• Other malignancy, except non-melanoma skin cancer, < 5 years prior to participation in the study; the disease free interval from any prior carcinoma must be continuous.
• Patients with diffuse disease

Where it is running

• Arizona Oncology Services — Phoenix, Arizona, United States
• Daniel Freeman Hospital — Inglewood, California, United States
• University of Southern California — Los Angeles, California, United States
• Cedars Medical Center — Miami Beach, Florida, United States
• St. Agnes Hospital — Baltimore, Maryland, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• NY Presbyterian — New York, New York, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• MD Anderson Cancer Clinic — Houston, Texas, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Swedish Cancer Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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