Surgery vs Active Monitoring for Low-Risk Ductal Carcinoma In Situ
(COMET Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude those who have used certain hormone therapies like tamoxifen, aromatase inhibitors, or raloxifene in the past 6 months, and those currently using exogenous hormones like oral progesterone.
What data supports the effectiveness of the treatment Active Monitoring for Low-Risk Ductal Carcinoma In Situ?
Is active monitoring safe for low-risk ductal carcinoma in situ (DCIS)?
How does the treatment of active monitoring differ from surgery for low-risk ductal carcinoma in situ?
Active monitoring involves regular check-ups and assessments to track the condition without immediate surgery, which can help avoid unnecessary procedures and their associated risks and costs. This approach is similar to how low-risk papillary thyroid microcarcinoma is managed, where active surveillance has shown to be effective in identifying patients who may eventually need surgery, while minimizing adverse events and medical expenses.910111213
What is the purpose of this trial?
This trial compares regular check-ups to surgery for women with low-risk Ductal Carcinoma in Situ (DCIS). The goal is to see if monitoring the condition without immediate surgery can provide similar outcomes in terms of cancer control and quality of life. Surgery can lead to persistent pain and other issues, so avoiding it might benefit patients. The study is examining the safety of monitoring low-risk DCIS without surgery.
Research Team
Shelley Hwang, MD
Principal Investigator
Duke University
Ann Partridge, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute
Alastair Thompson, MD
Principal Investigator
Baylor College of Medicine
Eligibility Criteria
This trial is for women aged 40 or older diagnosed with low-risk DCIS (a type of breast condition) who haven't had previous breast cancer in the same breast within 5 years. Participants should be able to undergo surgery if needed, have a good performance status, and agree to regular follow-ups. Pregnant women, those with certain serious conditions, or prior use of specific hormone treatments are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to either active monitoring or surgery with optional endocrine therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Active Monitoring
- Surgery
Active Monitoring is already approved in Canada for the following indications:
- Posttraumatic Stress Injuries (PTSI)
- Mental Health Risk and Resilience Factors
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance Foundation Trials, LLC.
Lead Sponsor
The University of Texas MD Anderson Cancer Center
Collaborator
Rising Tide Foundation
Collaborator
Breast Cancer Research Foundation
Collaborator
Patient-Centered Outcomes Research Institute
Collaborator
Duke University
Collaborator
Dana-Farber Cancer Institute
Collaborator
M.D. Anderson Cancer Center
Collaborator
New York University
Collaborator
Washington University School of Medicine
Collaborator