DCIS Clinical Trials

More research is needed to better understand ductal carcinoma in situ (DCIS) and how best to manage it. This includes both laboratory research, where scientists study tissue samples to better understand the biology of DCIS, and clinical trials, which involve patients. Clinical trials play a critical role in improving our understanding of DCIS and refining treatment approaches. Ongoing DCIS clinical trials are studying important questions such as active surveillance (monitoring without immediate surgery), risk prediction, and strategies to reduce overtreatment. This page provides an overview of clinical trials relevant to DCIS and explains what participation may involve.

What is a Clinical Trial?

A clinical trial is a research study involving patients that aims to answer a specific medical question. It represents the critical step when scientific discoveries move from the laboratory into real-world patient care.

Clinical trials are essential to advancing medical knowledge. The data collected helps improve how we prevent, diagnose, and treat diseases—including DCIS.

Should I Participate in a Clinical Trial?

There are many different types of clinical trials, each with its own eligibility criteria. Not every patient will qualify for every study.

There are both potential benefits and risks to participating in a clinical trial.

Potential benefits may include:

• Access to new treatments not yet widely available
• Close monitoring by a medical team
• The opportunity to contribute to research that may benefit future patients

Potential risks or downsides may include:

• Unknown side effects from new treatments
• Additional time commitments
• Travel, which may involve added cost or logistical challenges

There are important safety protections in place for all clinical trial participants. Patient safety is closely monitored, and trials undergo ongoing review by independent committees. If a trial is found to be unsafe, it is stopped. Participants are also free to withdraw at any time.

Deciding whether to participate in a clinical trial is a personal decision and should be made in consultation with your doctor and loved ones.

How Do I Find Out About Clinical Trials?

You can start by asking your doctor whether you may be eligible for any clinical trials for DCIS. Keep in mind that not all physicians are aware of every available trial, though those at research institutions may be more familiar with ongoing studies.

You can also search for trials on your own using trusted databases:

• BreastCancerTrials.org A clinical trial matching service that helps people with all stages of breast cancer find studies that may be a good fit. It lists hundreds of actively recruiting trials across the United States. Scroll down this page to access their DCIS-specific search.
• ClinicalTrials.gov A comprehensive database of clinical trials maintained by the U.S. government, including studies from around the world.

Both tools allow you to search by location and condition. To find studies specific to DCIS, try entering “DCIS” or “ductal carcinoma in situ.”

If you identify a trial you are interested in, discuss it with your doctor to determine whether it may be appropriate for you.

Clinical Trials for DCIS

Many DCIS clinical trials compare new approaches to the current standard of care. These studies help inform whether treatment can be improved, personalized, or safely reduced for certain patients.

If you are interested in exploring currently available DCIS clinical trials across the United States, visit the link below:

DCIS Clinical Trials

Active Surveillance Clinical Trials for DCIS

Some of the most important and promising research in DCIS is focused on active surveillance (also called active monitoring). This approach involves closely monitoring DCIS with regular imaging and exams, and delaying or avoiding surgery and radiation unless there are signs of progression.

These trials are especially relevant for patients with low-risk DCIS and have the potential to change the standard of care and help reduce over-treatment.

In the United States, there are currently two major active surveillance trials:

1. DCIS RECAST (Re-Evaluating Conditions for Active Surveillance Suitability as Treatment)

This study is evaluating whether some patients with hormone receptor–positive DCIS can safely manage their condition with endocrine therapy and active monitoring instead of surgery.

Participants are closely followed with imaging and clinical exams, with surgery remaining an option if needed.

The trial is open to women ages 18 and older with hormone-positive DCIS. To learn more or find participating sites, visit the Quantum Leap Health Collaborative website or email: [email protected].

2. COMET Trial (Comparing an Operation to Monitoring, with or without Endocrine Therapy)

The COMET trial is studying whether active monitoring (with or without endocrine therapy) is a safe alternative to surgery for patients with low-risk DCIS.

While COMET is no longer enrolling new participants, the study is ongoing. Early results released in December 2024 showed that patients who chose active monitoring were no more likely to develop invasive breast cancer in the same breast after two years compared to those who underwent surgery.

These findings represent an important early step toward potential treatment de-escalation for selected patients with low-risk DCIS. Read more about the COMET results here.