Surgery vs Active Monitoring for Low-Risk Ductal Carcinoma In Situ
(COMET Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two approaches for managing low-risk Ductal Carcinoma In Situ (DCIS), a non-invasive breast condition. Participants will either undergo surgery or participate in active monitoring, which involves regular check-ups without immediate surgery. The trial aims to determine if active monitoring can provide the same health and quality of life benefits as surgery. It suits women diagnosed with low-risk DCIS who can attend regular follow-up exams and do not have invasive breast cancer. As an unphased trial, it allows participants to contribute to important research that could enhance future treatment options.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that closely monitoring low-risk ductal carcinoma in situ (DCIS) is safe in the short term. Studies have found that this approach can yield similar results to traditional treatments like surgery, at least for a few years. One review found that monitoring did not lead to worse outcomes compared to surgery for low-risk cases. For some patients, monitoring might offer a gentler option without additional risks.
Conversely, surgery has long been a common treatment for DCIS. It typically involves removing the affected tissue, and some patients opt for additional treatments like radiation. While surgery carries its own risks, it has a proven track record of success in managing DCIS.
Overall, both active monitoring and surgery are considered safe for low-risk DCIS. Each option has its own benefits and risks, and discussing with healthcare providers is crucial to determine the best approach for each individual situation.12345Why are researchers excited about this trial?
Researchers are excited about the treatments for low-risk ductal carcinoma in situ (DCIS) because they offer different approaches to managing the condition. Unlike the traditional route of surgery, which often includes radiation and possibly endocrine therapy, active monitoring takes a less invasive path by regularly checking for changes with mammograms every six months and focusing on endocrine therapy when necessary. This approach could potentially reduce the need for surgery and its associated risks, offering a more personalized treatment plan. The excitement lies in exploring whether active monitoring can effectively manage DCIS while maintaining a high quality of life for patients.
What evidence suggests that this trial's treatments could be effective for low-risk DCIS?
This trial will compare Surgery with Active Monitoring for low-risk ductal carcinoma in situ (DCIS). Research has shown that closely monitoring low-risk DCIS can be safe and effective. Specifically, studies found that women with low-risk DCIS who chose this approach had a 98.1% chance of surviving the disease over eight years. Their quality of life and emotional well-being matched those who underwent surgery. After two years, the risk of the cancer becoming more serious did not increase for those who were monitored. This suggests that active monitoring could be a good alternative to surgery for some women with low-risk DCIS.36789
Who Is on the 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
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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