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Metastatic breast cancer (MBC) clinical trials are research studies aimed at finding more effective treatment options for people with advanced breast cancer or metastatic breast cancer — breast cancer that has spread to distant areas of the body.
Clinical trials test new treatments or treatment combinations for safety and efficacy. When you enroll in a research study, you may have access to the latest treatments that haven’t been approved yet. Participating in a clinical trial can also help others with MBC.
Some people decide to join a clinical trial when their treatments have failed. Others participate in a study in addition to their current treatment program.
What Are Clinical Trials?Clinical trials are research studies that test new treatments, such as medications or procedures. A clinical trial may also study new combinations of standard cancer treatments.
Some studies focus on preventing treatment side effects or improving patient quality of life as well. Every breast cancer treatment in the U.S. has gone through clinical trials before it’s approved.
Clinical trials can help to determine the standard of care and treatment plans for people with metastatic breast cancer. Participating in a clinical trial means that you may receive new treatments. However, it’s also possible to receive standard treatments that you’d receive anyway.
Clinical trials are always optional. It’s your decision if you want to join one, and you can leave one at any time. If you join a clinical trial, you will still receive care from your oncologist. If you decide against it, you can sometimes join a clinical trial later if you choose.
There are several times throughout the cancer journey when you may consider joining a clinical trial. Your oncologist may discuss it with you when:
Clinical trials aren’t just a last resort. Many people participate in one to enhance their current treatment or address side effects.
Every clinical trial has certain eligibility criteria for participants to join. The purpose of these criteria is to protect participants and help researchers collect reliable results. The rules may also lower the risk of serious side effects or complications.
For a metastatic breast cancer clinical trial, the criteria may involve:
Each phase of a clinical trial helps researchers understand different aspects of the new treatment.
The first phase of a cancer clinical trial is small and usually involves about 20 to 80 participants, although the numbers can vary. The goal is to make sure the new treatment is safe for a larger group.
Researchers pay special attention to any side effects that participants report. They use this data to determine the most effective dose of the new treatment that can be given safely.
At the start of some phase 1 trials, participants receive a low dose of the new treatment and are watched closely for side effects. Researchers follow a detailed study plan when deciding whether to test a higher dose. They consider how serious the side effects are, how often they happen, and how many people have them.
Phase 1 trials often involve more uncertainty because researchers are still learning about the treatment’s safety, side effects, and dose.
If a treatment shows enough promise in phase 1, researchers may study it in a larger group during phase 2. Many phase 2 cancer trials include fewer than 100 people, although the number can vary.
Researchers continue to study safety and may test one or more doses, treatments, or treatment combinations. Once a clinical trial passes the first phase, it can move on to a larger group of participants.
In phase 2 trials, researchers also begin to study how effective the treatment is for metastatic breast cancer. They will monitor tumor size and growth. They also want to understand if the new treatment could improve the quality of life in people with MBC.
When a clinical trial passes phase 2, it can progress to a much larger participant group. Phase 3 cancer trials may include hundreds or thousands of people, depending on the treatment and the purpose of the study. The goals of a phase 3 trial are to confirm that the treatment is effective and to continue monitoring for side effects or safety issues.
Researchers may compare the new treatment with a current cancer treatment to see which works better. Many phase 3 trials use random assignment, meaning a computer places participants into different treatment groups.
Some studies are blinded, but many cancer trials are open-label, meaning participants and doctors know which treatment is being given. Random assignment helps make the groups more alike and reduces bias.
Phase 4 studies take place after a treatment has been approved by the U.S. Food and Drug Administration (FDA) and made available to the public. Researchers may study long-term safety, rare side effects, how well the treatment works in larger groups, or whether it may help with other conditions.
During a phase 4 study, researchers may look at how the treatment affects survival and quality of life. These studies can also find rare or long-term side effects that were not seen earlier. FDA approval means more is known about the treatment, but it does not mean the treatment has no serious risks.
What To Consider When Joining a Clinical TrialThere are several factors to consider before joining a clinical trial, and the decision is always yours to make.
The first step in joining a clinical trial is informed consent. This means that the researcher or study representative explains the study and what is expected of you. Before participating in a clinical trial, you’ll want to understand the details of the study, including:
Once you join a clinical trial, know that you can leave it at any time. The entire process is voluntary.
Any medical treatment or procedure can come with risks. Before joining a clinical study, it’s important to understand any possible risks, such as treatment side effects or complications.
Some cancer treatments may cause discomfort. Ask the study coordinator several questions to understand how you could be affected by the trial. Consider asking about the possibility of short-term side effects, long-term complications, and how long they could last. It’s also important to understand the trial’s potential benefits.
Before joining a clinical trial, it’s important to understand the process and how your data will be used. In the U.S., there are safeguards in place to protect you and your health information.
An institutional review board (IRB) is an independent group that reviews a study before it begins. An IRB looks at the study’s risks, ethical rules, consent process, and plans for protecting participants. IRB approval does not remove every risk, but it helps make sure important protections are in place.
When considering joining a clinical trial, ask the study coordinator if the trial has been approved by an IRB. Details about the approval are also included in the informed consent form that you can check before you sign.
When considering a clinical trial, ask the study coordinator exactly what’s expected of you once you join. Factors to consider include:
A placebo, often referred to as a “sugar pill,” is an inactive substance. In some research studies, researchers may give half of the participants the new treatment and the other half a placebo.
In cancer treatment trials, people are rarely given only a placebo. A placebo is generally not used instead of an effective standard treatment.
However, a placebo-only group may sometimes be allowed when no effective standard treatment exists. More often, a placebo is given along with standard treatment.
Clinical trials are costly, so it’s important to understand if you’ll be responsible for any of the cost before joining. Possible expenses include:
In many cases, the study sponsor pays for the experimental treatment and tests that are required only for research. Health insurance may cover routine care, such as standard treatments, doctor visits, hospital care, lab tests, and imaging. Coverage rules and out-of-pocket costs can vary.
Before joining, ask the study coordinator, your insurance provider, and the hospital billing department which costs you may have to pay.
On MyBCTeam, people share their experiences with breast cancer, get advice, and find support from others who understand.
Are you considering joining a clinical trial for metastatic breast cancer? What questions do you still have? Let others know in the comments below.
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