What to Expect in Clinical Trials for Metastatic Breast Cancer

Health Writer
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Clinical trials have become common for numerous conditions, as a way to evaluate new treatments and medications that might improve on what’s currently available. Metastatic breast cancer is no different, according to Nicole Williams, M.D., of the Ohio State University Comprehensive Cancer Center. She notes that this type of cancer has a number of clinical trials in progress, geared toward improving quality of life, minimizing or eliminating symptoms of ongoing treatment, and lengthening life.

If you have metastatic breast cancer, how do you know if a clinical trial might be right for you? And what can you expect if you do join one? Here are some factors worth considering:

Cancer trials don’t use a placebo group

One very common concern among those considering clinical trials is that they’ll get placed in a group given only a placebo, which means they won’t receive “real” treatment, says Dr. Williams. But this is never the case for cancer, or for any condition where treatment is essential.

Often, she says, you’ll receive some type of standard care, and what’s involved in the trial will be a complement to your regular treatment. Even if the clinical trial has a novel therapy, or you’re using a single drug, you’ll still be closely monitored to ensure this is the best treatment for you.

“You’ll never be in a situation where you’re either receiving treatment OR you’re in a clinical trial,” says Dr. Williams. “They’re one and the same.”

You may want to join a trial early in your treatment

Another misconception is that clinical trials are only offered to patients toward the end of their disease, when treatment options are limited. Dr. Williams believes that considering a trial earlier can broaden your possibilities.

“Clinical trials are an excellent option for anyone with metastatic breast cancer, because it gives you more choices in terms of potential therapies,” she says. “Some of our patients with this type of cancer join a trial right after being diagnosed.”

Trials have specific goals

Clinical trials for metastatic breast cancer aren’t focused on a cure, Dr. Williams notes. Instead, they are mostly geared toward helping patients live longer or improving their symptoms. For example, a trial might be attempting to lower chronic pain related to metastases.

Other trials might be related to targeting gene mutations associated with the cancer, she adds, especially when it comes to delivering treatment based on those genetic markers.

“When looking at trials, understand what the larger purpose is,” Dr. Williams suggests. “This can help you determine if that matches with your own interests and goals.”

Not everyone is a good fit for a trial

There are disqualifying factors for many clinical trials, like confounding medical issues such as liver failure and kidney failure.

Also, there are trials where you will be randomized in terms of what type of therapy is planned, and not everyone is happy with the group they’re assigned, says Janie Grumley, M.D., breast surgical oncologist and director of the Margie Petersen Breast Center at Providence Saint John’s Center and associate professor of surgery at the John Wayne Cancer Institute in Santa Monica, California.

Fortunately, you’re never locked into a trial, and you can leave it whenever you want. For example, Dr. Grumley notes, some people who don’t like their randomized group simply stop participating in the trial. That happens so often that researchers anticipate that reaction when developing their trial protocols.

You’ll probably join when a trial is in a later phase

By the time a clinical trial is evaluating the effects of a drug or therapy on humans, it’s gone through several phases already, says Jack Jacoub, M.D., medical oncologist and medical director of the California-based MemorialCare Cancer Institute at Orange Coast Medical Center.

Earlier phases look at patient safety and efficacy, while later phases are geared toward replicating results, he notes. That means if you join a “phase 4” trial—which is the last step before FDA approval is sought—there will be plenty of data about results, including potential side effects and benefits.

Dr. Jacoub suggests talking with your doctor and the trial researchers about these aspects, so you know what to expect with that particular treatment, based on what trial participants have reported previously.

“In general, having an in-depth conversation about every aspect of a trial can help you gain a clearer understanding of the anticipated result,” he says.