Clinical Trial

Comparing an Operation to Monitoring, With or Without Endocrine Therapy (COMET) Trial For Low Risk DCIS

Study acronym: COMET
Active, Not Recruiting
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Summary
This study looks at the risks and benefits of active monitoring (AM) compared to surgery in the setting of a pragmatic prospective randomized trial for low risk DCIS. Our overarching hypothesis is that management of low-risk Ductal Carcinoma in Situ (DCIS) using an AM approach does not yield inferior cancer or quality of life outcomes compared to surgery.
Protocol Amendment History 42 amendments
This ClinicalTrials.gov record has been amended 42 times since 2016-10-05; most recent amendment 2026-05-08.
Status change: Recruiting → Active, Not Recruiting 2023-04-21
Status change: Not Yet Recruiting → Recruiting 2017-03-29
Trial Details
NCT Number NCT02926911
Lead Sponsor Alliance Foundation Trials, LLC.
Collaborators: Duke University, Dana-Farber Cancer Institute, New York University, Washington University School of Medicine, Patient-Centered Outcomes Research Institute, M.D. Anderson Cancer Center, Rising Tide Foundation, Breast Cancer Research Foundation
Conditions DCIS, Ductal Carcinoma in Situ
Enrollment 997 participants
Start Date 2017-02-22
Primary Completion 2024-06-27 (estimated)
Study Completion 2030-07 (estimated)
Updated on ClinicalTrials.gov 2026-05-12