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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00165256
Recruitment Status : Active, not recruiting
First Posted : September 14, 2005
Last Update Posted : December 12, 2019
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Julia S. Wong, MD, Dana-Farber Cancer Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Ductal Carcinoma in Situ of the Breast Other: Observation Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Wide Excision Alone for DCIS-Grades 1 and 2
Study Start Date : May 1995
Actual Primary Completion Date : July 2002
Estimated Study Completion Date : November 2021

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

Primary Outcome Measures :
  1. To determine if patients with DCIS can be effectively treated with wide excision alone. [ Time Frame: TBD-survivorship ]

Secondary Outcome Measures :
  1. To explore whether patients with grade 2 DCIS have a higher breast recurrence than patients with grade 1 DCIS. [ Time Frame: TBD-survivorship ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00165256

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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
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
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Principal Investigator: Julia Wong, MD Dana-Farber Cancer Institute
Publications of Results:
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Responsible Party: Julia S. Wong, MD, Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT00165256    
Other Study ID Numbers: 94-151
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Julia S. Wong, MD, Dana-Farber Cancer Institute:
Ductal carcinoma in situ
wide excision
Additional relevant MeSH terms:
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Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Breast Carcinoma In Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases