The BREAKWATER study will help us learn if two study drugs (encorafenib plus cetuximab) can be safe and effective when given alone or with chemotherapy in people with metastatic colorectal cancer who have the BRAF V600E gene mutation.

Who may participate

Thank you for your interest in the BREAKWATER clinical research study. We’re looking for 870 people who have been diagnosed with metastatic colorectal cancer and have not received prior treatment (exceptions may apply).

Condition
Metastatic colorectal cancer (Stage 4) with the BRAF V600E gene mutation

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Age
16+ (where applicable)

The age a person must be to participate in a clinical trial.

Sex
Male and Female

The sex of people who may participate in a clinical trial. Sex is a person’s classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

View more eligibility criteria

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

What to expect

Pre-screening and screening periods: The study team will confirm that participants have the BRAF V600E gene mutation and see if this study could be a good fit for them. This may include performing a physical exam and taking blood and urine samples.

Treatment period: Participants will be randomly assigned to one of three potential treatment groups.

  • Group 1 will receive the oral study drug (encorafenib) and the intravenous (IV) infusion study drug (cetuximab)
  • Group 2 will receive the oral study drug (encorafenib), IV infusion study drug (cetuximab), and chemotherapy
  • Group 3 will receive current standard of care chemotherapy

If you qualify and choose to take part, the study team will discuss dosage and potential treatment plans with you.

Monitoring periods: The study team will perform some tests and monitor participants’ health.

Length of study treatment
Participants can continue to receive the study drugs until they and/or their study doctor determine if/when they should stop

Length of study treatment is the length of time the study participants will receive the study treatment.

Number of study visits
One study visit every two or three weeks until participation ends

Each clinical trial’s design specifies the number of study visits and the total length of the trial.

Long-term follow up
One follow-up visit and then a phone call once every three months

Some studies require the study team to stay in contact with the participant for a period of time after the participant completes the main part of the study. This long-term follow up is to collect additional information on the study drug over time.

What does participation involve?

Participants can continue to receive the study drugs (encorafenib plus cetuximab) until they and/or their study doctor determine if or when they should stop. During this time, one study visit will occur every two or three weeks. All participants will receive the study drugs or standard of care chemotherapy.

During this research study, participants will have certain tests, procedures, and assessments. What happens at each study visit will vary and some study visits may take longer than others. Assessments may include blood samples, physical exams, magnetic resonance imaging (MRI) scans, tumor samples, and electrocardiograms (ECGs).

About the study drugs

The first study drug, encorafenib, is a daily oral drug. The second study drug, cetuximab, is given every two weeks as an intravenous (IV) infusion.

The study drugs are thought to work by targeting cancerous BRAF proteins and potentially slowing down the growth of cancer cells. The BREAKWATER study will evaluate if this targeted therapy can help people with the BRAF mutation.

Frequently asked questions

What is BRAF V600E?

Mutations are changes in the DNA of some cancer cells that can be targeted with certain therapies. The BRAF mutation is a type of mutation found in approximately 10% to 15% of people with colorectal cancer. These mutations activate proteins that lead to cancer growth.

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How are the study drugs given?

The first study drug, encorafenib, is a daily oral drug. The second study drug, cetuximab, is given every two weeks as an intravenous (IV) infusion.

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What is an intravenous (IV) infusion?

An intravenous (IV) infusion is a needle attached to a bag that holds the study drug (cetuximab), delivering the drug into the vein.

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Will support be available?

The study drugs and any study-related procedures are generally covered at no cost. You may be reimbursed for reasonable expenses (such as parking, meals, and/or travel) that you may have incurred while taking part in this research study.

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Is insurance required?

Participants do not need health insurance to take part in research studies.

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What are the potential risks?

By participating, your health may get better, get worse, or stay the same. If your health gets worse, your study team and your study doctor will help you decide what to do, which may mean stopping your participation in the study.

Potential risks from taking part in the study may include:

  • Fatigue, weakness, and/or headache
  • Decreased appetite, nausea, vomiting, and/or diarrhea
  • Rash and/or other skin irritations
  • Muscle and/or joint pain
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What are the potential benefits?

Potential benefits from taking part in this study may include:

  • Your health will be closely monitored during the study
  • Participation may help future patients by increasing our understanding of the investigational drugs and metastatic colorectal cancer
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What happens to my personal information?

Information about personal health will be kept private and confidential. If you decide to contact us, your details will be transferred to the study team. A representative from the team will contact you to better understand if the study is right for you.

Your personal information will not be disclosed to anyone outside of this clinical research study without your consent unless disclosure is required by law or regulations of the U.S. Food and Drug Administration (FDA) or other regulatory agencies.

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Why do we need clinical research studies?

Research studies (or clinical trials) are a type of medical research in which people volunteer to take part. All medicines and vaccines that become available today for use in people are first tested in studies involving hundreds to thousands of volunteers. Research studies gather knowledge about medical conditions and potential ways to treat or prevent them.

While all potential medicines are first studied in a lab, researchers need to understand if they could be safe and effective in people before they are made available to use. The more scientists understand about how a potential medicine works, the better they are able to develop solutions that work for more people. That’s why participation is so important. Without clinical studies and those who take part, modern medicine could not exist!

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