NCT00165256

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for phase_2

Timeline
19mo left

Started May 1995

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
May 1995Dec 2027

Study Start

First participant enrolled

May 1, 1995

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
22.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

7.2 years

First QC Date

September 9, 2005

Last Update Submit

December 22, 2025

Conditions

Ductal Carcinoma in Situ of the Breast

Keywords

Ductal carcinoma in situDCISwide excision

Outcome Measures

Primary Outcomes (1)

  • To determine if patients with DCIS can be effectively treated with wide excision alone.

    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 Outcomes (1)

  • To explore whether patients with grade 2 DCIS have a higher breast recurrence than patients with grade 1 DCIS.

    TBD-survivorship

Study Arms (1)

Observation (omission of RT)

EXPERIMENTAL

Wide excision of DCIS; no radiotherapy (RT).

Other: Observation

Interventions

ObservationOTHER

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

Observation (omission of RT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • 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.

    PMID: 16461781RESULT

  • 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.

    PMID: 24346130RESULT

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating

Interventions

Observation

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Julia Wong, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

May 1, 1995

Primary Completion

July 1, 2002

Study Completion (Estimated)

December 1, 2027

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)