CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 997 enrolled
Drug / intervention
Surgery +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02926911
NCT02926911N/AActive
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Comparing an Operation to Monitoring, With or Without Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial

Alliance Foundation Trials, LLC.·interventional·Posted Oct 6, 2016·Updated May 12, 2026

In Brief

A clinical study evaluating Surgery and Active Monitoring for DCIS and Ductal Carcinoma in Situ. Active but no longer recruiting, targeting 997 participants across 141 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDCIS, Ductal Carcinoma in Situ
CountriesUnited States
CollaboratorsDuke 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

Timeline

N/AActive
20172018201920202021202220232024202520262027202820292030
First PostedOct 6, 2016
Enrollment StartFeb 22, 2017
Primary CompletionJun 27, 2024
Study CompletionJul 1, 2030
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 9.7 years ago

Interventions

Surgeryother

Surgery +/- radiation choice for endocrine therapy

Active Monitoringother

Choice for endocrine therapy