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

StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Primary completion pushed from Jul 2002 to Jan 1, 2022v19 Show 4 more changesShow less
    • Trial completed
    • Study completion moved earlier from Dec 2027 to Jun 25, 2026
    • Enrollment target: 158 to 157
    • Start date: May 1995 to May 15, 1995
  2. Study completion date: Nov 2025 to Dec 2027
    • Publications: details revised at 2 of 2 entries
    v18
  3. Study completion date: Nov 2024 to Nov 2025
    • Publications: details revised at 2 of 2 entries
    v17
  4. Study completion date: Nov 2023 to Nov 2024v16
  5. Secondary endpoints: details revised at 1 of 1 entryv15
Show 13 earlier versionsHide 13 earlier versions
  1. 2 versions Re-verified since Jul 14, 2022, no change to tracked fieldsv13-v14
  2. Study completion date: Nov 2022 to Nov 2023v12
  3. Study completion date: Nov 2021 to Nov 2022v11
  4. Study completion date: Nov 2019 to Nov 2021v10
  5. Phase: Not specified to Phase 2
    • Trial status: Terminated to Active, Not Recruiting
    • Study completion date: Apr 2017 to Nov 2019
    v9
  6. Phase: Phase 2 to Not specifiedv8
  7. Trial status: Active, Not Recruiting to Terminated Sponsor's reason: The pre-specified stopping boundary was reached.v7 Show 6 more changesShow less
    • Enrollment target: 200 to 158
    • Study completion date: Apr 2016 to Apr 2017
    • Interventions: Wide Excision of DCIS (Procedure) to Observation (Other)
    • Eligibility criteria expanded, about 135 words
    • Study description expanded, about 24 words
    • Study sites revised (2)
  8. Study arms: 0 to 1v6
  9. Study completion date: Apr 2015 to Apr 2016v5
  10. Study completion date: Apr 2010 to Apr 2015v4
  11. Study completion date: Jul 2008 to Apr 2010v3
  12. Primary completion date: Jul 2002
    • Study completion date: Jul 2008
    • Secondary endpoints: details revised at 1 of 1 entry
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT00165256
Lead Sponsor Dana-Farber Cancer Institute
Collaborators: Brigham and Women's Hospital, Massachusetts General Hospital, Beth Israel Deaconess Medical Center
Conditions
(from sponsor)		 Ductal Carcinoma in Situ of the Breast
Related terms Carcinoma, Intraductal, Noninfiltrating
Enrollment 157 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov