Protocol Summary
Protocol No.
100288 (AFT-25)
Principal Investigator
Matsen, Cindy
Phase
N/A
Age Group
Adult
ClinicalTrials.Gov
NCT02926911 (Click to jump to clinicaltrials.gov)
Eligibility Detail
Contact
Elyse D'Astous
Clinical Research Coord
+1 801-587-4323
elyse.d'astous@hci.utah.edu
Title
Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial for Low Risk DCIS: Phase III Prospective Randomized Trial
Objective
To study the risks and benefits of active surveillance (AS) compared to guideline concordant care (GCC) in the setting of a pragmatic prospective randomized trial for low risk DCIS. Our overarching hypothesis is that management of low-risk DCIS using an AS approach does not yield inferior cancer or quality of life outcomes compared to GCC.
Primary Objective:
To assess whether 2-year ipsilateral invasive cancer rate for AS is non-inferior to that for GCC.
Secondary Objectives:
To determine whether AS is non-inferior to GCC for the following outcomes: 2-year mastectomy rate, breast conservation rate; 2-year contralateral invasive breast cancer rate; 2-year overall survival and breast cancer specific survival; health-related QOL at 1 year, 2 years; anxiety and depression and other psychosocial outcomes at 1 year, 2 years
Applicable Disease Sites
Breast
Participating Institutions
HCI Farmington; HCI South Jordan; Huntsman Cancer Institute
Status
Open
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