Breast cancer clinical trials — also called research studies — are designed to find more effective treatments for breast cancer. Some people with breast cancer may decide to participate in a research study for the opportunity to try a new therapy. Others may wish to contribute to medical knowledge to help other people with breast cancer.
This is an exciting time for breast cancer research. There are studies for many types and stages of breast cancer. Researchers recruit volunteers to help them learn more about breast cancer and evaluate new treatments that can potentially improve cancer care and outcomes.
If you have breast cancer, you may be eligible for a new clinical trial. Even if you’re not currently thinking about participating in a clinical trial, it’s a good idea to learn the basics about how oncology research studies work.
When you participate in a clinical trial, you may gain access to new treatments that are in development, new combinations of treatments, or existing treatments under review for new types of use. Some clinical trials don’t test new drugs at all and instead evaluate ways to improve cancer prevention, overall health, or survivorship. Medical devices, such as those used to perform mammograms, also undergo clinical trials.
The treatment being studied is called an investigational drug or therapy. Every existing treatment has gone through a clinical trial, and some participants in those trials had early access to new therapies.
By joining a clinical trial, you can also help ensure that the study population includes people of your age, race, and ethnic background. Diverse study populations help scientists better understand how breast cancer treatments work among people across a variety of demographics.
The specific goals of clinical trials vary, but researchers are looking for more effective ways to treat breast cancer and improve the quality of life for those living with the disease. Research studies are often seeking answers to these types of questions:
A placebo, sometimes called a “sugar pill,” is designed to look like the treatment being studied but doesn’t have any active ingredients. To test the effectiveness of an investigational treatment, clinical trials may assign a group of participants a placebo in order to compare results. In every clinical study, participants are informed if there is a chance they might receive a placebo, rather than the treatment under study.
Placebos are rarely used alone in cancer clinical trials because it would be unethical to withhold treatment. In most cancer studies, an investigational treatment is compared to an existing treatment. A placebo may be used without additional treatment in a cancer trial only if no effective treatment currently exists.
Placebos may also be used when a clinical trial is testing an existing treatment in combination with a new treatment. One group of participants might receive the existing treatment plus a placebo, and another group would receive the existing treatment in combination with the investigational drug or therapy.
In most trials, the group that receives the investigational treatment versus the group that takes a placebo — or existing treatment — is decided randomly to avoid bias. This process is called randomization. Many research studies are also double-blind, meaning neither the trial participants nor the researchers know which participants are receiving which treatment until the trial is over.
In some clinical trials, when the investigational treatment appears to be much more effective than the treatment it’s being compared to, the new treatment may be made available to all participants at some point in the study. When considering a clinical trial, it’s important to ask questions about the study design and whether you would have access to the investigational treatment if it proves effective.
The safety of participants is a priority in clinical trials, and there are safeguards in place to protect you. These protections were carefully developed in response to historical wrongdoings in which individuals’ rights were not maintained in medical research.
In this day and age, clinical trials in the United States are overseen by the U.S. Food and Drug Administration (FDA), which is mandated by law to protect human safety. Other regulatory boards serve a similar function in countries around the world.
In the United States, an ethical body called an Institutional Review Board (IRB) approves and monitors the majority of clinical trials. The IRB’s role is to protect the safety and rights of participants in clinical research studies. IRBs assess studies to ensure that the potential benefits of clinical trials are significantly greater than the risks and that appropriate precautions are in place to protect participants. If it is determined during the course of the trial that it is no longer safe to proceed, the study will be discontinued.
Before joining a research study, you will be given thorough information about the goals of the trial and potential risks for participants. Clinical trials are required to help you make an educated decision about volunteering in a study. This process is called informed consent.
All treatments, including standard treatments, have potential risks of adverse reactions or side effects. Clinical trials are meticulously designed to minimize risks. Participants in clinical trials are carefully monitored to determine if a treatment is safe and if the potential benefits outweigh the potential risks. The informed consent process gives you plenty of time to ask questions and consider whether you are comfortable with the study before you join a clinical trial. This process allows you to discuss the trial with your doctor, family members, and others you rely on for advice.
You will also be given general information about the research study, such as how much time will be required, any costs, what kind of travel may be involved, and what the medical procedures of the trial involve. Costs for clinical trials are usually covered by the company or organization sponsoring the trial, along with health insurance.
There are different phases of clinical trials. Phase 1 trials focus primarily on the safety, dosage, method of taking treatment, and side effects of the investigational therapy. Phase 2 and phase 3 trials recruit larger numbers of participants and focus on efficacy (how well a treatment works) in addition to safety.
A research study for breast cancer is likely to focus on a particular type of breast cancer and stages of the disease, such as early-stage breast cancer, advanced breast cancer, or metastatic breast cancer. Each trial has specific criteria regarding who is eligible to participate. These criteria may include age, disease stage, types of treatment you have had, and what your response to other treatments has been. Some studies may be focused on breast cancer that involves cancer cells with specific genetic mutations.
At any given time, hundreds or thousands of clinical trials for breast cancer are currently underway. Some of these trials focus only on individuals with advanced disease or those who have not seen improvement with other medications. Other trials include people with lower-risk disease.
When you agree to participate in a clinical trial, you are a volunteer. You have the right to withdraw from a research study at any time, for any reason, even if the study is still in progress. Signing consent documents and agreeing to participate in a trial is not a contract that requires you to stay in the trial if you choose to withdraw.
If you decide to leave a clinical study, let the research staff know, so that you can be formally withdrawn. Depending on the trial, you may need to undergo monitoring when discontinuing study treatment. If you are considering withdrawing, reach out to the study team or your doctor first, so you can discuss questions or concerns.
Breast cancer studies usually take place in clinical settings, and you may have similar monitoring and follow-up care to what you are accustomed to at the research study cancer center. However, despite the additional care and clinical visits you may have in a research study, people in clinical studies generally still see their regular health care providers.
The medical care you receive as part of the trial doesn’t replace comprehensive health care. Your doctors can coordinate with the research team to help ensure that the clinical trial treatment is compatible with any other treatments you are taking. Your oncologist can help you understand how participating in a research study might affect your care.
You can ask your doctor about clinical trials for which you may be eligible, or search for studies at ClinicalTrials.gov.
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