Wide Excision Alone as Treatment for Ductal Carcinoma in Situ of The Breast

This study is ongoing, but not recruiting participants.

First Received: September 9, 2005 Last Updated: October 30, 2009 History of Changes

Sponsor:	Dana-Farber Cancer Institute
Collaborators:	Brigham and Women's Hospital Massachusetts General Hospital Beth Israel Deaconess Medical Center
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00165256

Purpose

The purpose of this study is to determine if wide excision (surgical removal) of the ductal carcinoma in situ of the breast (DCIS) alone is adequate therapy.

Condition	Intervention	Phase
Duct Carcinoma in Situ of the Breast	Procedure: Wide Excision of DCIS	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	Wide Excision Alone for DCIS-Grades 1 and 2

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To determine if patients with DCIS can be effectively treated with wide excision alone. [ Time Frame: TBD-survivorship ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To explore whether patients with grade 2 DCIS have a higher breast recurrence than patients with grade 1 DCIS. [ Time Frame: TBD-survivorship ] [ Designated as safety issue: No ]

Enrollment:	200
Study Start Date:	May 1995
Estimated Study Completion Date:	April 2010
Primary Completion Date:	July 2002 (Final data collection date for primary outcome measure)

Intervention Details:

Wide excision of DCIS and a minimum of 1cm histologically negatic breast tissue

Detailed Description:

Treatment consists of wide excision that will remove the area of DCIS and a minimum of 1cm histologically negative margin of breast tissue. A post-excision mammogram will be performed to verify complete excision of all calcifications.
Follow-up consists of physical examinations at least every 6 months by the surgeon or radiation oncologist. Mammograms of the affected breast will be obtained every 6 months for 5 years and then annually. Mammograms of the unaffected breast will be performed annually.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have high quality mammogram including magnification views of area containing suspicious calcifications.
The clinical extent of DCIS must be less than or equal to 2.5cm.
Grade 1 or 2 DCIS

Exclusion Criteria:

Patients with invasive carcinoma including microinvasive disease
Patients with nipple discharge
Patients with a history of prior malignancies other than squamous or basal cell carcinoma of the skin, or carcinoma in situ of the cervix.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165256

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Center
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator:

Julia Wong, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Dana-Farber Cancer Institute/Brigham and Women's Hospital ( Julia Wong, MD )
Study ID Numbers:	94-151
Study First Received:	September 9, 2005
Last Updated:	October 30, 2009
ClinicalTrials.gov Identifier:	NCT00165256 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Duct carcinoma in situ
DCIS
wide excision

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal
Carcinoma in Situ
Carcinoma, Ductal, Breast
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms by Histologic Type

Skin Diseases
Breast Neoplasms
Neoplasms
Neoplasms by Site
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 20, 2009