Elevate Your Health Colorado: Your Health Information Resource

Health care providers are dedicated to offering breast cancer patients the best treatments available. This sometimes includes access to cutting edge and experimental therapies that are only available to patients who participate in clinical trials.

But what, exactly, are clinical trials, and how can patients participate in them?

Clinical trials are carefully monitored research studies that take place before new treatments are introduced to the general public to ensure their safety and effectiveness.

“Once patients are diagnosed with breast cancer and the stage of the cancer is established, oncologists will discuss treatment options,” explains John F. Steiner, MD, MPH, research director of the Institute for Health Research at Kaiser Permanente Colorado. “For some, an option may be to participate in a clinical trial so they can gain access to new treatment options.”

Oncology teams at Kaiser Permanente Colorado are very proactive in identifying patients who may be good candidates for clinical trials. They also provide information about the benefits and the risks to help patients decide if participating is right for them – the patient is always free to choose.

Why participate?
“Patients want to do everything they can to combat their cancer,” Dr. Steiner says. “Many go into clinical trials with the hope that a new treatment will be an improvement over current options. Still, it is important for patients to realize that clinical trials offer no guarantees.”

Another reason to participate is a sense of altruism. “Everything we know today about preventing and treating breast cancer is the result of clinical trials that were conducted over the past 20 to 30 years,” Dr. Steiner continues. “Many participate in trials because they know it will help us gather knowledge that can benefit future breast cancer patients.”

Are clinical trials safe?
Before patients can participate in a clinical trial, an institutional review board evaluates the proposed study to make sure it respects the safety and rights of every potential participant. This board is comprised of health experts and community members who have no financial or scientific ties to the study. Board members also review documents stating all known risks, which enable potential participants to have the information they need to provide informed consent.

“In clinical trials involving breast cancer patients, the goal is to evaluate new treatments that might offer greater benefits or fewer side effects than the current best standards,” Dr. Steiner explains. “I think people sometimes worry about getting a placebo, which is essentially no treatment. But patients with breast cancer who participate in clinical trials receive either the current best standards of care, a promising modification to the current best standards, or additional treatments along with these standards.”

A leader among peers
Several qualities set Kaiser Permanente Colorado apart from other health care providers involved in clinical trials. “Our main focus is to provide options for our patients,” says Betsy Nugent, MSPH, CCRP, senior manager of clinical trials at the Institute for Health Research at Kaiser Permanente Colorado.

“Because of our electronic medical records, our team of researchers and clinicians can evaluate what clinical trials may be an option and discuss them with patients during their next office visit. This makes it easy on patients because they immediately know which options are available to them, and they do not need to come in for a separate research screening,” Nugent says. “We are also able to monitor patients for failed therapies and offer new clinical trials when they may reach eligibility.”

Approximately 15 to 20 percent of all breast cancer patients at Kaiser Permanente Colorado are eligible to participate in a clinical trial. Today, about 175 breast cancer patients are either actively participating or enrolled in follow-up studies. Kaiser Permanente Colorado recently won an award for being the state’s highest enroller in oncology clinical trials from the Colorado Cancer Research Program, funded by the National Cancer Institute.

Nugent and her colleague, Rafael Veintimilla, MD, the clinical trials implementation consultant at Kaiser Permanente Colorado, have been very active in advocating for legislation to be passed to make sure other insurance providers would cover patients who wish to participate in clinical trials. Because of their efforts, more patients now have access to the same cutting-edge therapies Kaiser Permanente provides its patients when they participate in clinical trials.

“If you are thinking about participating in a clinical trial, it is important to become as informed as possible about all it entails,” Nugent adds. “And feel free to ask questions.”

To learn more about clinical trials, visit KaiserPermanente.org.

Dr. Steiner received his medical degree from the University of Pennsylvania. He completed his internship and residency at the University of Colorado and fellowship at the University of Washington. He is board certified in internal medicine and conducts health sciences research.