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

December 5, 2023 updated by: Julia S. Wong, MD, Dana-Farber Cancer Institute

Wide Excision Alone for DCIS-Grades 1 and 2

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients must have high quality mammogram including magnification views of the area containing suspicious calcifications.
  • A specimen radiograph is required. If the specimen radiograph does not assure removal of all suspicious microcalcifications, a post-operative mammogram showing removal of all suspicious calcifications is required.
  • The clinical extent of DCIS must be less than or equal to 2.5 cm.
  • Grade 1 or 2 DCIS; patients with lobular carcinoma-in-situ (LCIS) in addition to DCIS in the breast are eligible. Negative margins are not required on the LCIS.
  • Patients must undergo a wide excision. A re-excision after the initial biopsy might be needed. Complete resection of the area of DCIS with a histologic margin of at least 1 cm must be achieved.
  • Patients must be enrolled on this protocol within 3 months of the last surgical procedure.

Exclusion Criteria:

  • Patients with invasive carcinoma including microinvasive disease
  • Carcinoma found in the sampled lymph nodes if axillary dissection is done
  • Patients with nipple discharge
  • Patients with adjuvant chemotherapy or Tamoxifen
  • Patients with a history of prior malignancies other than squamous or basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
  • Patients with a history of ipsilateral or contralateral breast carcinoma or DCIS or simultaneous bilateral DCIS.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Observation (omission of RT)
Wide excision of DCIS; no radiotherapy (RT).
Other: Observation
Wide excision of DCIS and a minimum of 1cm histologically negative margin of breast tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine if patients with DCIS can be effectively treated with wide excision alone.
Time Frame: TBD-survivorship
Using information gathered from follow-up physical examinations and mammography to check for recurrence (DCIS or invasive carcinoma in the breast), DCIS patients treated with wide excision alone will be evaluated.
TBD-survivorship

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To explore whether patients with grade 2 DCIS have a higher breast recurrence than patients with grade 1 DCIS.
Time Frame: TBD-survivorship
Using information gathered from follow-up physical examinations and mammography, the exploration of breast recurrences between grade 2 DCIS and grade 1 DCIS patients will be evaluated.
TBD-survivorship

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital

Investigators

  • Principal Investigator: Julia Wong, MD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1995

Primary Completion (Actual)

July 1, 2002

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimated)

September 14, 2005

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 94-151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ductal Carcinoma in Situ of the Breast

Clinical Trials on Observation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe