The first study medicine, (encorafenib), is a daily oral drug. The second study medicine, (cetuximab), is given every two weeks as an intravenous (IV) infusion. The study medicines 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.
Investigating two study drugs as a potential first treatment for people with metastatic colorectal cancer
The BREAKWATER study will help us learn if two study medicines (encorafenib plus cetuximab) can be safe and effective when given 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 trial. We’re looking for approximately 815 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
Age
16+ (where applicable)
Sex
Male and Female
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.
Additional eligibility criteria
- Have been diagnosed with metastatic colorectal cancer (Stage 4)
- Have the BRAF V600E gene mutation
- Are 16+ (where applicable)
- Have not received prior treatment (exceptions may apply)
What to expect
Pre-screening/screening periods: The study team will confirm that you have the BRAF V600E gene mutation and will perform a physical exam and take blood and urine samples to see if the study is a good fit.
Treatment period: Participants will be randomly assigned to one of two potential treatment groups.
- Group 1 will receive the oral study drug (encorafenib), IV infusion study drug (cetuximab), and chemotherapy
- Group 2 will receive one of the current standards 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 your health.
Length of study treatment
You can continue to receive the study medicines until you and/or your study doctor determine if/when you should stop
Number of study visits
One study visit every two or three weeks until participation ends
Long-term follow up
One follow-up visit and then a phone call once every three months
About the study medicines
About the study medicines
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.
How are the study medicines given?
The first study medicine, (encorafenib), is a daily oral drug. The second study medicine, (cetuximab), is given every two weeks as an intravenous (IV) infusion.
What is an intravenous (IV) infusion?
An intravenous (IV) infusion is a needle attached to a bag that holds the study medicine (cetuximab), delivering it into the vein.
Will support be available?
The study medicines 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 clinical trial.
Is insurance required?
You do not need health insurance to take part in clinical trials.
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 clinical trial.
Potential risks from taking part in the clinical trial 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
What are the potential benefits?
Potential benefits from taking part in this clinical trial may include:
- Your health will be closely monitored
- Participation may help future patients by increasing our understanding of the investigational medicines and metastatic colorectal cancer
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.
Why do we need clinical research studies?
Clinical trials (or research studies) 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. Clinical trials 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 trials and those who take part, modern medicine could not exist.
