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

NCT ID: NCT00165256

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-05-31

Study Completion Date

2027-12-31

Brief Summary

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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

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* 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

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Ductal Carcinoma in Situ of the Breast

Keywords

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Ductal carcinoma in situ DCIS wide excision

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Observation (omission of RT)

Wide excision of DCIS; no radiotherapy (RT).

Group Type EXPERIMENTAL

Observation

Intervention Type OTHER

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

Interventions

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Observation

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Julia S. Wong, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julia Wong, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Wong JS, Kaelin CM, Troyan SL, Gadd MA, Gelman R, Lester SC, Schnitt SJ, Sgroi DC, Silver BJ, Harris JR, Smith BL. Prospective study of wide excision alone for ductal carcinoma in situ of the breast. J Clin Oncol. 2006 Mar 1;24(7):1031-6. doi: 10.1200/JCO.2005.02.9975. Epub 2006 Feb 6.

Reference Type RESULT
PMID: 16461781 (View on PubMed)

Wong JS, Chen YH, Gadd MA, Gelman R, Lester SC, Schnitt SJ, Sgroi DC, Silver BJ, Smith BL, Troyan SL, Harris JR. Eight-year update of a prospective study of wide excision alone for small low- or intermediate-grade ductal carcinoma in situ (DCIS). Breast Cancer Res Treat. 2014 Jan;143(2):343-50. doi: 10.1007/s10549-013-2813-6. Epub 2013 Dec 18.

Reference Type RESULT
PMID: 24346130 (View on PubMed)

Other Identifiers

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94-151

Identifier Type: -

Identifier Source: org_study_id