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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