Breast Cancer Clinical Trial

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

Summary

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

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Full Description

Data relevant to the evaluation of the efficacy and safety of the MammoSite RTS system in providing radiation therapy to patients with DCIS will be collected. The MammoSite is a radionuclide applicator designed to deliver internal radiation therapy (brachytherapy) in patients with breast tumors following breast tumor resection surgery (lumpectomy).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

133

Study ID:

NCT00586326

Recruitment Status:

Completed

Sponsor:

Hologic, Inc.

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There are 12 Locations for this study

See Locations Near You

Arizona Oncology Services
Phoenix Arizona, 85032, United States
Daniel Freeman Hospital
Inglewood California, 90301, United States
University of Southern California
Los Angeles California, 90033, United States
Cedars Medical Center
Miami Beach Florida, 33136, United States
St. Agnes Hospital
Baltimore Maryland, 21229, United States
William Beaumont Hospital
Royal Oak Michigan, 48073, United States
NY Presbyterian
New York New York, 10065, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
MD Anderson Cancer Clinic
Houston Texas, 77030, United States
Virginia Commonwealth University
Richmond Virginia, 23298, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

133

Study ID:

NCT00586326

Recruitment Status:

Completed

Sponsor:


Hologic, Inc.

How clear is this clinincal trial information?

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