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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00586326
Recruitment Status : Completed
First Posted : January 4, 2008
Results First Posted : October 22, 2012
Last Update Posted : November 6, 2012
University of Southern California
Information provided by (Responsible Party):
Hologic, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
DCIS Device: MammoSite Radiation Therapy System Phase 2

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MammoSite Radiation Therapy System (RTS) as the Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (DCIS)
Study Start Date : August 2003
Actual Primary Completion Date : January 2006
Actual Study Completion Date : April 2011

Arm Intervention/treatment
Experimental: Women with DCIS
Women with DCIS
Device: MammoSite Radiation Therapy System
The MammoSite is a balloon catheter that is designed to position a radioactive source inside the lumpectomy cavity. The MammoSite applicator is inserted into the cavity created by the tumor removal surgery. The MammoSite applicator is then inflated and expands to fill the cavity.

Primary Outcome Measures :
  1. Local Control Rate for Follow-up Period of 5 Years. [ Time Frame: Data collected at the time of implant, radiation therapy, and at the patient's 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year follow-up visits. ]
    Failure of local control was defined as a histologically confirmed recurrence (invasive or non-invasive) within the prescription isodose volume. All recurrences were to have histological evaluation per the protocol; however, the case report forms did not provide space for this data to be captured. Ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrence or distant metastases were not considered treatment failures unless accompanied by ipsilateral breast failure.

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: At 5 Years ]
  2. Cause Specific Survival [ Time Frame: At 5 Years ]
  3. Disease Free Survival [ Time Frame: At 5 Years ]
  4. Cosmetic Evaluations Over Time [ Time Frame: At 5 Years ]
    As assessed using the four category Harvard Scale for subjects with an evaluation at the 5 year timepoint

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00586326

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

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Responsible Party: Hologic, Inc. Identifier: NCT00586326     History of Changes
Other Study ID Numbers: MS-700
First Posted: January 4, 2008    Key Record Dates
Results First Posted: October 22, 2012
Last Update Posted: November 6, 2012
Last Verified: November 2012
Keywords provided by Hologic, Inc.:
Additional relevant MeSH terms:
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Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Breast Carcinoma In Situ