Start date

01-07-2016; first site opened for recruitment February 2017.

Sites open

80 sites open to recruitment

Trial website


Story so far

The COMET trial operates within the Alliance for Clinical Trials in Oncology Network and is sponsored by the Patient-Centered Outcomes Research Institute (PCORI). Dr. Shelley Hwang, Chief of Breast Surgery at Duke University is the Principal Investigator for the study. The COMET study has been open since July 2016: the first site opened for recruitment in February 2017; the first patient enrolled to the trial in June 2017. The trial has now randomized 253 patients within 80 sites open to recruitment.

Current status

Open to recruitment

Patients recruited/accrual target


Challenges and opportunities

Challenges to site accrual include slower onboarding process due to IRB/contractual issues and frequent turnover of site staff; challenges to recruitment include small number of low-risk DCIS patients seen at each site and the need to change eligibility criteria relating to necrosis/comedonecrosis in the study protocol. Other challenges include COMET study social media presence and website promotion. Opportunities include a new CRESt (COMET Recruitment Enhancement Strategy) initiative during 2019 that is expected to further increase accrual to the study.

Useful links

What is the COMET Study?

COMET Team Celebrates 200!