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Wide Excision Alone as Treatment for Ductal Carcinoma in Situ of The Breast | Clinical Trials | Clareo Health

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

Wide Excision Alone for DCIS-Grades 1 and 2

NCT00165256•Dana-Farber Cancer Institute

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

May 1, 1995

Primary Completion Date

July 1, 2002

Completion Date

December 1, 2027

Last Updated

December 29, 2025

Enrollment

158

ACTUAL participants

Conditions

Ductal Carcinoma in Situ of the Breast

Interventions

Observation

OTHER

Axillary Reverse Mapping (ARM) Technique

NCT03109522

Invasive Breast CancerDuctal Carcinoma in Situ of the Breast

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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