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

This study has been terminated.
(The pre-specified stopping boundary was reached.)
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 Identifier:
First received: September 9, 2005
Last updated: July 5, 2016
Last verified: July 2016
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 Intervention Phase
Ductal Carcinoma in Situ of the Breast
Other: Observation
Phase 2

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Wide Excision Alone for DCIS-Grades 1 and 2

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine if patients with DCIS can be effectively treated with wide excision alone. [ Time Frame: TBD-survivorship ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To explore whether patients with grade 2 DCIS have a higher breast recurrence than patients with grade 1 DCIS. [ Time Frame: TBD-survivorship ] [ Designated as safety issue: No ]

Enrollment: 158
Study Start Date: May 1995
Estimated Study Completion Date: April 2017
Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00165256

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

Responsible Party: Julia S. Wong, MD, Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT00165256     History of Changes
Other Study ID Numbers: 94-151 
Study First Received: September 9, 2005
Last Updated: July 5, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Dana-Farber Cancer Institute:
Ductal carcinoma in situ
wide excision

Additional relevant MeSH terms:
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on October 25, 2016