Here’s what you need to know about joining a clinical trial in metastatic breast cancer.
Know Your Breast Cancer Type
To better understand what trials you might be able to join, it’s important to know the type of metastatic breast cancer you have, explains Rita Nanda, MD, the director of the Breast Oncology Program at University of Chicago Medicine.
If you don’t have any of these targets, that means you have triple-negative breast cancer, and you will be eligible for trials designed for this type of breast cancer.
When breast cancer spreads or recurs, it can be the same type as the first time you had it, or it can change to a different subtype, Dr. Nanda says.
Types of Clinical Trials
Clinical trials aim to answer specific questions about a new therapy or existing treatments that require further study.
- Phase 1 These trials are performed in a small group of people to determine the appropriate dose of the treatment or drug and to examine side effects.
- Phase 2 These trials involve hundreds of people and evaluate the effectiveness of the new treatment. They also further assess its safety and side effects.
- Phase 3 These are often conducted in multiple places across the country, involving thousands of participants. These trials further evaluate the safety, effectiveness, and side effects of the new treatment, and compare the new treatment to the existing standard of care. A request will ultimately be submitted to the FDA for approval to make the drug available to the public.
- Phase 4 These trials take place after a treatment has been approved by the FDA and is being sold to the public. The purpose is to monitor the long-term safety of the new drug in a much larger, more diverse group of people in the real world.
Is Joining a Clinical Trial Right for You? Pros and Cons
“Clinical trials are the way that we improve [cancer] treatment,” says Nanda. But participating in a trial has pros and cons from the patient perspective, she says.
The benefits of joining a clinical trial may include:
- The chance of getting a new, effective drug before it’s commercially available
- Better medical attention than you might usually receive
- Helping other patients by contributing to cancer research
- Sometimes getting paid to participate
The challenges of participating in a trial might include the following:
- Having to travel long distances if the trial isn’t taking place close to home
- Spending more time for extra tests and procedures, such as more blood draws and biopsies
- No guarantee that you will receive the investigational drug or therapy being tested, as treatment is given according to the study plan
- Finding out you are not eligible to participate because of strict rules for entry into a clinical trial
Dr. Lustberg says she discusses clinical trials with her patients often. “[People with metastatic breast cancer] are always on some type of therapy and need serial treatment changes. Any time there is a need to alter something … [we] evaluate all options — standard-of-care therapy and clinical trials.”
Standard-of-care therapy is the “gold standard” that has been proven in clinical trials to be the best treatment currently available for breast cancer, and has been approved by the FDA.
Lustberg notes, however, that not all doctors discuss clinical trials with their patients and, in particular, there is “a lot of unconscious bias on the part” of some physicians when it comes to non-white patients. But, “if given the chance, [many of] these women would want to participate in clinical trials,” she stresses.
If your doctor has never mentioned clinical trials, you can be the one to bring it up and ask about potentially joining a trial.
Do Clinical Trials Increase Survival?
Still, the authors of this study noted that other researchers have found different results, so “the promotion of clinical trials for cancer due to survival benefit must be done with caution,” they say.
Lustberg agrees that not all studies on this topic show the same results, but she insists that the survival data in metastatic breast cancer are more favorable than for some other cancers.
Ultimately, whether to join a trial is a personal decision you make with your doctor.
How to Find Clinical Trials in Metastatic Breast Cancer
New breast cancer treatment breakthroughs can only happen with the aid of clinical trials. Here’s where you can find out about clinical trials you may be eligible for.
- Your doctor: Ask your oncologist if you may be eligible for a clinical trial, and how to find one that’s a good fit for you.
- ClinicalTrials.gov: This online resource is maintained by the National Library of Medicine, where clinical studies are registered and updated. Visit the site and search “actively recruiting” and “metastatic breast cancer,” or a more specific term if you know your breast cancer subtype, and add suitable locations for you. If it’s hard to understand the wording on the site, print out the information or send the link to your doctor so you can discuss it at your next appointment.
- Patient advocacy groups and nonprofit organizations: There are a number of patient support groups for metastatic breast cancer that give information on clinical trials, including BreastCancerTrials.org (which offers a Metastatic Trial Search function), the Metastatic Breast Cancer Alliance, and the Triple Negative Breast Cancer Foundation. You can also visit the American Cancer Society for reliable information on breast cancer clinical trials.
- Online forums: Join online forums and support groups through social media platforms. Search #metastaticbreastcancer, #MBC, #bcsm (for breast cancer social media), or the subtype you have. This should help connect you to other patients and doctors who are posting about this disease.
As of March 2024, more than 300 clinical trials in metastatic breast cancer actively enrolling in the United States were identified on ClinicalTrials.gov.
Beware of False Claims: Always Discuss New Treatments With Your Doctor First
“I’ve had many patients [come to ask me about] a clinical trial because they are part of a Facebook group. Patients find out [about clinical trials] from other patients and from online support groups. We try to help them as much as we can. If they are interested in a specific clinical trial that we don’t have [at our institution], we can try to find them places to go,” Nanda says.
But some patients don’t want to connect with others, Nanda says, and they prefer to handle things on their own or have one-on-one counseling. “Everybody is different, so we have a dedicated social worker to help.”
Lustberg also encourages her patients to look online and tap into other resources to research their cancer. But there can be downsides to searching the web, she says.
“There are often unsubstantiated claims about this supplement or that supplement that might take the place of standard-of-care treatment,” Lustberg says.
And she warns that there are myths about clinical trials in metastatic breast cancer. “I want to make sure that we [doctors] have effectively dispelled those,” she says. One such myth is that patients might get a placebo [dummy pill] in a study, but Lustberg assures patients that this is not the case in metastatic breast cancer.
“Standard of care is always given [if you’re not given the drug being tested]. It would not be ethical otherwise,” Lustberg says. “I don’t want my patients to be afraid to look online by themselves. I just want to help them distinguish what is good.”
