What side effects are associated with this type of intervention?

For Ductal Carcinoma in Situ (DCIS), active monitoring involves regular surveillance and follow-up without immediate surgery, which generally has minimal side effects but requires diligent adherence to follow-up schedules. Endocrine therapy, such as tamoxifen, can cause side effects like hot flashes, vaginal dryness, and an increased risk of thromboembolic events, while lower doses may reduce these risks but are less studied. Aromatase inhibitors, another endocrine option, can lead to bone density loss, fractures, and cardiovascular risks. Radiation therapy, often used post-lumpectomy, can cause skin irritation, fatigue, and a long-term risk of secondary cancers, though it significantly reduces local recurrence rates.

What prior FDA approvals exist?

For the treatment of Ductal Carcinoma in Situ (DCIS), the FDA has approved endocrine therapies such as tamoxifen and aromatase inhibitors. Tamoxifen, typically administered at a dose of 20 mg daily, has been shown to reduce recurrence rates in DCIS patients. Lower doses, such as 10 mg every other day, are sometimes used for patients experiencing significant side effects. Aromatase inhibitors like anastrozole are also approved for postmenopausal women with ER-positive DCIS. These treatments align with the Active Monitoring approach, which involves regular surveillance and follow-up without immediate surgery.

What other types of research exist?

Promising alternatives to Active Monitoring for Ductal Carcinoma patients include: 1) Endocrine therapy with tamoxifen or aromatase inhibitors for ER-positive DCIS, which reduces recurrence rates. 2) Breast-conserving therapy (BCT) combined with postoperative tamoxifen, which has been shown to be effective in preventing ipsilateral recurrences. 3) Participation in clinical trials such as the COMET trial, which compares the outcomes of surgery versus monitoring. These options should be discussed with a healthcare provider to tailor the best treatment plan for the individual patient.

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Surgery vs Active Monitoring for Low-Risk Ductal Carcinoma In Situ (COMET Trial)

N/A

Waitlist Available

Led By Shelley Hwang, MD, MPH

Research Sponsored by Alliance Foundation Trials, LLC.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of unilateral, bilateral, unifocal, multifocal, or multicentric DCIS without invasive breast cancer, atypia verging on DCIS, or DCIS + LCIS

Patient who has had a lumpectomy or partial mastectomy with margins positive for DCIS as part of their treatment for a current DCIS diagnosis

Must not have

Color/bloody nipple discharge (ipsilateral breast)

Current use of exogenous hormones

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2, 5, and 7 year follow-up

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from the interventions in this trial could include typical risks associated with surgeries such as infection, bleeding, pain at the incision site, and possible complications from anesthesia. Active monitoring itself does not involve direct side effects but may carry risks related to delayed treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I had surgery for breast cancer with some cancer cells found at the edge of the removed tissue.

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I was 40 years or older when diagnosed with DCIS.

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I haven't had breast cancer or DCIS in the same breast within the last 5 years.

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I am medically cleared for surgery.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am currently taking hormone medications.

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I am a male diagnosed with DCIS (a type of breast cancer).

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My condition is Grade III DCIS.

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My recent mammogram showed a suspicious area in my breast not yet checked by a biopsy.

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I have been diagnosed with invasive or microinvasive breast cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2, 5, and 7 year follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2, 5, and 7 year follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2, 5, and 7 year follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Upper arm

Secondary study objectives

Breast cancer specific survival rate

Breast conservation rate

Contralateral invasive cancer rate

+10 more

Other study objectives

Adherence to hormonal therapy

Body image

Breast MRI utilization rate

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Active MonitoringExperimental Treatment1 Intervention

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

Group II: SurgeryActive Control1 Intervention

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

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Ductal Carcinoma in Situ (DCIS) include surgery, radiation therapy, and endocrine therapy. Surgery, such as lumpectomy or mastectomy, physically removes the cancerous tissue. Radiation therapy uses high-energy rays to kill any remaining cancer cells in the breast after surgery, reducing the risk of recurrence. Endocrine therapy, such as tamoxifen, blocks hormones like estrogen that can promote the growth of cancer cells. In the context of Active Monitoring, regular surveillance and follow-up are crucial as they allow for the early detection of any progression, enabling timely intervention while potentially avoiding overtreatment. This approach is particularly important for patients with low-risk DCIS, where the risks of immediate surgery may outweigh the benefits.

Estimating the magnitude of clinical benefit of local therapy in patients with DCIS.Whole-breast irradiation with or without a boost for patients treated with breast-conserving surgery for early breast cancer: 20-year follow-up of a randomised phase 3 trial.