NCT04607421
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 alone or with chemotherapy in people with metastatic colorectal cancer who have the BRAF V600E gene mutation.
Who may participate
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
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.
About the study medicines
About the study medicines
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.
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.
