Surgery vs Active Monitoring for Low-Risk Ductal Carcinoma In Situ

(COMET Trial)

Not currently recruiting at 143 trial locations

Overseen By Nancy DeMore, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Alliance Foundation Trials, LLC.

Must not be taking: Tamoxifen, Aromatase inhibitors, Raloxifene, Hormones

Disqualifiers: Male DCIS, Grade III DCIS, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 5 years

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. ^{1 2 3 4 5}

Why 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. ^{3 6 7 8 9}

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

I have been diagnosed with a type of non-invasive breast cancer.

Baseline imaging requirements met

Amenable to follow-up examinations

Exclusion Criteria

I have colored or bloody discharge from the nipple on one side.

I have taken tamoxifen, an aromatase inhibitor, or raloxifene in the last 6 months.

I had a lump found by exam or imaging before being diagnosed with DCIS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either active monitoring or surgery with optional endocrine therapy

5 years

MMG every 6-12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 years

Annual follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Active Monitoring
• Surgery

Trial Overview

The COMET Trial is comparing active monitoring versus surgery for managing low-risk Ductal Carcinoma In Situ (DCIS). The study aims to determine whether active monitoring leads to similar cancer outcomes and quality of life as compared to surgical intervention.

How Is the Trial Designed?

Group I: Active Monitoring Experimental Treatment 1 Intervention

DCIS - Choice for endocrine therapy (MMG q 6 months x 5 years GCC for invasive progression)

Group II: Surgery Active Control 1 Intervention

DCIS - Surgery +/- radiation choice for endocrine therapy (MMG q 12 months x 5 years usual care for recurrent disease)

Active Monitoring is already approved in Canada for the following indications:

Approved in Canada as Active Monitoring for:

• Posttraumatic Stress Injuries (PTSI)
• Mental Health Risk and Resilience Factors

Who Is Running the Clinical Trial?

Alliance Foundation Trials, LLC.

Lead Sponsor

Trials

25

Recruited

27,200+

The University of Texas MD Anderson Cancer Center

Collaborator

Trials

2

Recruited

1,100+

Rising Tide Foundation

Collaborator

Trials

17

Recruited

6,200+

Breast Cancer Research Foundation

Collaborator

Trials

79

Recruited

40,500+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

New York University

Collaborator

Trials

249

Recruited

229,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

In a study of 14,419 women treated for ductal carcinoma in situ (DCIS) in the Netherlands, those who underwent breast-conserving surgery (BCS) alone had a higher risk of developing ipsilateral invasive breast cancer (iIBC) compared to those who received BCS plus radiotherapy (RT), with a cumulative incidence of 7.1% versus 3.1% after 10 years.

The risk of iIBC remained significantly elevated in the BCS alone group for at least 10 years post-treatment, indicating that adding radiotherapy after BCS may provide a protective effect against the development of invasive cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of contemporary treatment of DCIS on the risk of developing an ipsilateral invasive Breast cancer (iIBC) in the Dutch population. Alaeikhanehshir, S., Schmitz, RSJM., van den Belt-Dusebout, AW., et al.[2023]

In a study of 37,544 women with a clinical diagnosis of non-high-grade ductal carcinoma in situ (DCIS), 22.2% were found to have invasive carcinoma upon final pathologic examination, highlighting the risk of underestimating invasive cancer in these patients.

Factors such as younger age, negative estrogen receptor status, treatment at academic facilities, and higher income were significantly associated with an upgraded diagnosis of invasive carcinoma, suggesting that these should be considered when deciding on active surveillance for DCIS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated With Underestimation of Invasive Cancer in Patients With Ductal Carcinoma In Situ: Precautions for Active Surveillance. Chavez de Paz Villanueva, C., Bonev, V., Senthil, M., et al.[2022]

Active surveillance (AS) for low-risk papillary thyroid microcarcinoma (PTMC) showed similar oncological outcomes to immediate surgery (IS) in a study of 816 patients, suggesting it is a viable treatment option.

Patients undergoing IS experienced significantly higher rates of temporary vocal cord paralysis and hypoparathyroidism, along with more complaints about quality of life related to voice and scarring, indicating that AS may offer a safer alternative with fewer adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active surveillance versus immediate surgery: A comparison of clinical and quality of life outcomes among patients with highly suspicious thyroid nodules 1 cm or smaller in China. Liu, C., Zhao, H., Xia, Y., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12219084/

An early economic evaluation of active surveillance for low- ...

AS for low-risk ductal carcinoma in situ is cost-effective, but a better-performing biomarker to select low-risk women can maximize quality-adjusted outcomes.

2.

cancernetwork.com

cancernetwork.com/view/active-monitoring-may-be-safe-vs-surgery-in-certain-low-risk-dcis-populations

Active Monitoring May Be Safe Vs Surgery in Certain Low ...

Active monitoring rather than surgery may show short-term safety among patients with low-risk ductal carcinoma in situ (DCIS) and yield acceptable outcomes.

3.

bmj.com

bmj.com/content/390/bmj-2024-083542

Cancer outcomes in women without upfront surgery for ...

Among the 650 women with low risk DCIS, eight year disease specific survival was 98.1% (95% CI 96.7% to 99.6%), compared with 94.4% (91.6% to ...

4.

esmo.org

esmo.org/oncology-news/active-monitoring-promising-for-women-with-low-risk-ductal-carcinoma-in-situ

Active Monitoring Promising for Women with Low-Risk ...

These results show that at 2 years, patients randomised to active monitoring have non-inferior invasive breast cancer risk in the affected breast.

5.

news-medical.net

news-medical.net/news/20241212/Active-monitoring-for-low-risk-DCIS-results-in-similar-quality-of-life-as-standard-treatment.aspx

Active monitoring for low-risk DCIS results in similar quality ...

Patients with low-risk ductal carcinoma in situ (DCIS) who underwent active monitoring reported comparable physical, emotional, and psychological outcomes

6.

acsjournals.onlinelibrary.wiley.com

acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.70013

Active monitoring of DCIS shows promise in short‐term study

These results show that after 2 years, active monitoring apparently resulted in similar outcomes in comparison with guideline-concordant care ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11457553/

Outcomes from low-risk ductal carcinoma in situ

This review showed a lower risk of progression and better survival in women who received surgery and additional RT for low-risk DCIS.

8.

jamanetwork.com

jamanetwork.com/journals/jamaoncology/article-abstract/2828196

Patient-Reported Outcomes for Low-Risk Ductal ...

Reported data comparing patient-reported outcomes (PROs) between GCC and AM for DCIS are lacking.

9.

ascopost.com

ascopost.com/issues/may-10-2025/is-active-monitoring-a-safe-option-for-patients-with-ductal-carcinoma-in-situ/

Is Active Monitoring a Safe Option for Patients With Ductal ...

Active monitoring for low-risk DCIS is safe, at least in the short term. Active monitoring is acceptable to patients, at least in the COMET ...