Active Monitoring With or Without Endocrine Therapy for Low-Risk Ductal Carcinoma In Situ: The COMET Randomized Clinical Trial.

ABSTRACT:

Importance

Active monitoring for low-risk ductal carcinoma in situ (DCIS) of the breast has been proposed as an alternative to guideline-concordant care, but the safety of this approach is unknown.

Objective

To compare rates of invasive cancer in patients with low-risk DCIS receiving active monitoring vs guideline-concordant care.

Design, setting, and participants

Prospective, randomized noninferiority trial enrolling 995 women aged 40 years or older with a new diagnosis of hormone receptor-positive grade 1 or grade 2 DCIS without invasive cancer at 100 US Alliance Cancer Cooperative Group clinical trial sites from 2017 to 2023.

Interventions

Participants were randomized to receive active monitoring (follow-up every 6 months with breast imaging and physical exa

SUBMITTER: Hwang ES 

PROVIDER: S-EPMC11920841 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature