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COMET: DCIS - Clinical Trial

What is the Purpose of this Study?

We are doing this study to compare the risks and benefits of the usual treatment approach for DCIS with a close disease- monitoring approach.

What is the Condition Being Studied?

Ductal Carcinoma in Situ (DCIS)

Who Can Participate in the Study?

Adult women over age 40 who:
- Have a new diagnosis of DCIS without invasive cancer
- Have no prior history of breast cancer in either breast

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Be randomized (like a flip of a coin) into one of two treatment groups:
--- Group 1 will get traditional treatment with radiation, surgery, and chemotherapy
--- Group 2 will have close monitoring of their disease with possible chemotherapy

- Have tests, exams, and procedures that are part of your standard of care and for study purposes

Study Details

Full Title
Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial for Low Risk DCIS: A Phase III Prospective Randomized Trial
Principal Investigator
Protocol Number
IRB:PRO00080888
NCT:NCT02926911
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698