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

December 21, 2007
November 2, 2012
August 2003
January 2006   (final data collection date for primary outcome measure)
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.
The primary efficacy endpoint of the treatment will be measured by the local control rate for the stated 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 ]
Complete list of historical versions of study NCT00586326 on ClinicalTrials.gov Archive Site
  • 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
Disease Free Survival, Cause Specific Survival, Contralateral Breast Failure [ 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 ]
Not Provided
Not Provided
 
MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ
MammoSite Radiation Therapy System (RTS) as the Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (DCIS)

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

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).

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.
Experimental: Women with DCIS
Women with DCIS
Intervention: Device: MammoSite Radiation Therapy System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
April 2011
January 2006   (final data collection date for primary outcome measure)

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
Female
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00586326
MS-700
No
Hologic, Inc.
Hologic, Inc.
University of Southern California
Principal Investigator: Oscar Streeter, MD University of Southern California
Hologic, Inc.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP