COMET

Comparison of Operative to Monitoring and Endocrine Therapy (COMET) trial for low risk DCIS: A phase III prospective randomized trial.

Objective

Ductal carcinoma in situ (DCIS) is considered the earliest detectable form of pre-breast cancer. Almost all women with DCIS experience no symptoms. Cancerous cells are present in DCIS but they are trapped within certain areas of the breast called ducts. DCIS is therefore not considered an invasive cancer and most cases will not progress to invasive disease. Despite this low risk for progression, current standards for treating DCIS include surgery such as mastectomy, radiation and hormonal therapy. In this trial a participant with low-risk DCIS will be randomly chosen to either receive the standard treatment or be randomly chosen to undergo active monitoring instead. Active monitoring requires no surgery or radiation but instead requires more frequent mammograms and doctor visits to closely monitor whether the disease is progressing or not. If evidence during this monitoring suggests that the cancer is spreading, then standard treatment with surgery and radiation may be reconsidered. The goal of this study is to better understand whether close monitoring of DCIS is adequate in managing the disease rather than treating it with the more invasive treatments currently used.

Sponsor

• Alliance Foundation Trials, LLC.

Principal Investigator

• Kristi Harrington, MD, PhD

Sponsors

• University of Washington
• Fred Hutchinson Cancer Research Center

Contact

• Email the Clinical Research team

Resources

• DCIS Options.
• ClinicalTrials.gov: Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS (COMET).