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

This study has been completed.
Sponsor:
Collaborator:
University of Southern California
Information provided by (Responsible Party):
Hologic, Inc.
ClinicalTrials.gov Identifier:
NCT00586326
First received: December 21, 2007
Last updated: November 2, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
DCIS
Device: MammoSite Radiation Therapy System
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: MammoSite Radiation Therapy System (RTS) as the Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (DCIS)

Resource links provided by NLM:


Further study details as provided by Hologic, Inc.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    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:
  • Overall Survival [ Time Frame: At 5 Years ] [ Designated as safety issue: Yes ]
  • Cause Specific Survival [ Time Frame: At 5 Years ] [ Designated as safety issue: Yes ]
  • Disease Free Survival [ Time Frame: At 5 Years ] [ Designated as safety issue: Yes ]
  • Cosmetic Evaluations Over Time [ Time Frame: At 5 Years ] [ Designated as safety issue: No ]
    As assessed using the four category Harvard Scale for subjects with an evaluation at the 5 year timepoint


Enrollment: 133
Study Start Date: August 2003
Study Completion Date: April 2011
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586326

Locations
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
Investigators
Principal Investigator: Oscar Streeter, MD University of Southern California
  More Information

No publications provided

Responsible Party: Hologic, Inc.
ClinicalTrials.gov Identifier: NCT00586326     History of Changes
Other Study ID Numbers: MS-700
Study First Received: December 21, 2007
Results First Received: September 20, 2012
Last Updated: November 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Hologic, Inc.:
MammoSite
DCIS

Additional relevant MeSH terms:
Carcinoma
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Carcinoma, Ductal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 26, 2014