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People diagnosed with metastatic breast cancer (MBC) may consider volunteering for a clinical trial. Clinical trials are research studies that investigate new medicines, medical procedures, and treatment approaches in order to determine their safety and efficacy. Some may test new doses or new combinations of current therapies. Others may measure the impact a specific therapeutic approach has on patients’ quality of life. Others may evaluate how different diagnostic approaches can help individual patients select the best treatment.
Just as there are different clinical trials, there are different reasons to join one, ranging from the chance to try a different treatment approach that isn’t available anywhere else, to the opportunity to make a valuable contribution to MBC research, which may benefit other people with MBC.
Before applying to take part in a clinical trial, it helps to understand a bit more about the different types of clinical trials, what the application process can be like, and why you need to consider the risks and benefits.
Clinical trial phases
Most clinical trials are divided into different phases, with each phase designed to collect specific kinds of information:
- Phase 0 clinical trials typically involve a small number of patients taking small doses of a new drug. These trials are used to determine if a therapy is worth investigating and if it is safe to investigate, but do not include therapeutic goals.
- Phase I clinical trials put new investigational drugs or strategies to use in people for the first time. These trials are designed to determine dosage, safety, and side effects.
- Phase II clinical trials test the new drug or strategy in a larger group of participants to measure its effectiveness and reinforce the findings of Phase I studies, including safety and side effects.
- Phase III clinical trials broaden the research to a larger group of participants, studying diverse populations, as well as different dosages and different drug combinations. At this stage, the therapy being studied is often compared to an existing therapy, with the goal of determining if the new therapy improves upon the existing therapy. Researchers are also looking to identify side effects and safety concerns. At the conclusion of a phase III clinical trial, results are submitted to the Food and Drug Administration (FDA) for approval.
- Phase IV clinical trials take place after the drug has been formally approved. During this phase, researchers are interested in monitoring the drug in diverse populations, as well as different regimens, dosing schedules, and the long term benefits and side effects.
Deciding to apply
Before applying to a clinical trial, it is important that you have a clear understanding of your own motivations for wanting to participate, and also clear expectations about what the clinical trial will entail and how it can impact your life. Some questions you should ask include:
- How does the treatment being studied compare to your current treatment?
- How will taking part in the trial impact your current treatment?
- How will taking part in the trial impact your everyday life?
- What are the potential risks and benefits?
- How is the treatment administered?
- What kind of testing will be involved?
- Will it cost you anything to participate in the study?
- Will you be reimbursed for any costs you incur?
Remember that there is no guarantee that you will be accepted into a trial, that the treatment will work for you, or that you will even be given the drug that is being studied—in later phase studies there’s always the chance that you will part of a control group that is taking a standard therapy.
You’ll need to consider these issues carefully when deciding whether a clinical trial is a good fit for you.
Finding a clinical trial
If you’re interested in learning more about clinical trials, talk to your healthcare providers. They can advise you on what clinical trials may be a good fit for you, and help explain what participation may mean for your treatment. The National Institutes of Health has a database of clinical trials. Visit the website at ClinicalTrials.gov to learn about upcoming opportunities.
