NCT00165256

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

Wide Excision Alone for DCIS-Grades 1 and 2

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if wide excision (surgical removal) alone is adequate treatment for small, grade 1 or 2 ductal carcinoma in situ (DCIS) of the breast.

Detailed description

* Patients with DCIS are usually treated with the combination of breast-conserving surgery and radiation therapy or breast-conserving surgery alone. The purpose of this study is to evaluate whether localized low- or intermediate-grade DCIS, diagnosed with modern mammography and careful pathologic evaluation, could be treated with wide excision alone (omission of radiation therapy) and result in acceptably low local recurrence rates. * 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.

Conditions

• Ductal Carcinoma in Situ of the Breast

Interventions

Type	Name	Description
OTHER	Observation	Wide excision of DCIS and a minimum of 1cm histologically negative margin of breast tissue

Timeline

• Start date: 1995-05-01
• Primary completion: 2002-07-01
• Completion: 2027-12-01
• First posted: 2005-09-14
• Last updated: 2025-12-29

Locations

2 sites across 1 country: United States