With an estimated 313,500 cases of invasive breast cancer diagnosed in the U.S. each year, many of us know someone who has been affected by the disease. Fortunately, breast cancer is one of the most actively researched disease types in the U.S., says Inova oncologist Dr. Melissa Yacur. Over the last 40 years, findings from clinical trials, which look at new ways to prevent, treat, or detect disease, have been key to implementing safer or more effective treatments that result in better outcomes for patients.
“Clinical trials are how new drugs or new treatment paradigms get approved or get FDA approval,” Yacur says. “A clinical trial is a very structured way of testing new drugs or new treatment options to see how effective they are.”
Clinical trials are research studies involving people to determine whether a drug or treatment is safe and beneficial. Phase 1 and Phase 2 trials involve small numbers of people, while Phase 3 can involve up to 3,000 people and compares the new treatment with the current treatment. If the U.S. Food and Drug Administration finds the results of the third trial support the drug’s use, it will approve the experimental drug or treatment for a fourth phase that involves several thousand people who have the disease.
These potentially groundbreaking clinical trial results wouldn’t be possible without the patient volunteers who agree to undergo new treatments or new combinations of standard care treatments.
Exciting Discoveries
“In breast cancer, things move very, very quickly,” Yacur says about treatments. “From year to year, there’s new stuff that comes out that actually changes our standard of care.”
Yacur points to a recent trial called Ember-4 that looks at “upgraded or improved endocrine therapy” as a success story. “We’re one of the top recruiting sites in the world for this trial, which is really exciting.”
And Inova is not the only Northern Virginia health organization participating robustly in clinical trials. Dr. Alexander Spira, an oncologist who is co-director of clinical research at Virginia Cancer Specialists Research Institute, is also enthusiastic about progress. “There’s been a lot of excitement over the last year or two with the approval of several drugs, especially targeting HER2-positive patients,” he says. “So there’s a few new HER2 drugs that are out there. There are new drugs coming down the pike for patients with rare mutations as well.
“New immunotherapies have been approved; there’s been a new antibody–drug conjugate that’s likely to be approved this year,” Spira says. “There’s been a lot of headway made with these new therapies available to patients both in the past and coming up shortly as well.”
While no breast cancer cure has been found, death rates dropped an estimated 42 percent from 1989 through 2021, according to the American Cancer Society. And every year, advancements offer the promise of hope.
Patient Benefits
Besides helping to advance the research, why would a patient choose to undergo a clinical trial?
“The biggest benefit of doing a clinical trial is that potential to get a drug that is going to be better, before it’s actually FDA-approved. Because once these drugs come out and they’re in trials sometimes it takes years, breast cancer sometimes longer, five to 10 years or more, before we have real data to get an FDA approval,” Yacur says. “There is always, always a very long and detailed discussion when we meet with patients to discuss trials, because it’s important for them to understand what the standard of care is and then how the trials differ from that.”
Another benefit may include cost savings for patients, since pharmaceutical companies cover the drugs used in the trials. “It should never be the sole reason patients do it, but there is often that advantage as well,” Spira says. “They also get a lot more TLC from our staff because we have to ask them a lot of questions, so they get a lot more monitoring.” He estimates that in Virginia Cancer Specialists’ two clinical trial programs, there were about 150 employees for 500 to 600 patients a year.
Dianne Hirsch, a patient with metastatic breast cancer and a professional background in cancer research, has participated in two clinical trials. The first was in 2005 at Virginia Cancer Specialists after her mastectomy, and it was a Phase 3 trial. The second one, which she began last year, was a Phase 1 trial. This study used an antibody–drug conjugate, which is a drug that contains an antibody that targets tumor cells and is bound with a chemotherapeutic drug that functions to kill the cancer cells. “They were trying to see what’s the maximum tolerated dose for patients and what kind of side effects they have,” Hirsch says about the second trial.
She didn’t experience negative side effects during the first trial but experienced some uncomfortable side effects like anemia and thrombocytopenia in the second. That trial, which Hirsch had been in for nine months, was discontinued because of the side effects of the study drug. However, Hirsch did see a reduction in tumor size. She says she was disappointed when the trial was discontinued but recognizes it was the right decision. “It wasn’t fun getting sick, but it was still worth it for me because the treatment was working,” she says.
Hirsch adds that advancements in genetic screening and personalized medicine are making it an exciting time for new therapies. “I see it as a really exciting time because they can do more about your tumor since they have more information to make decisions about what might work,” she says.
Weighing the Effects
Hirsch says because she is at the early stages of metastatic disease, she doesn’t describe herself as living with a terminal illness but rather “a chronic illness,” similar to someone who lives with diabetes or heart disease. This framing has been helpful to her mindset. “I’m not letting the cancer take over my life. And I think that’s really important,” she says. “For people that are considering [clinical trials], keep that on your radar. … Is being in a clinical trial going to eventually really, really upset you so that you can’t be living your daily life?”
Factors to consider include the extra time spent on monitoring and testing appointments. Hirsch says she was fortunate to have a very understanding workplace when it came to taking time off for appointments, but not everybody does.
“There’s always extra work built in for a couple of reasons. One is for safety. You know, if a drug has not been FDA-approved, we have to do a lot of monitoring for safety,” Spira says. He adds that the trial may involve “extra blood work, extra testing, extra biopsies to help figure out why these drugs work, so we can develop the next generation of drugs and try and narrow down the patient who gets the drugs.”
To potential clinical trial patients, Hirsch says two factors are key to a positive experience: trust in the treatment team and awareness of the details. “They really need to ask their doctor to explain how the drug works. And in a way that you can understand it,” she says. “Doctors should be open to giving you as much information as possible.” Before participating in a trial, she suggests asking to see the infusion room, “since you’re going to be spending a lot of time there,” and see “if the nurses are friendly, if the atmosphere is comfortable.” She also recommends that patients find out exactly who does what on a treatment team, from the research coordinator to the administrative nurse, and find out exactly whom to contact for any specific needs.
“Our therapies improved dramatically over 20 years,” Spira says. “And the reason we were able to do that is because of physicians putting patients on clinical study and patients going through the exercise of doing it. And without that, we wouldn’t be where we are right now.”
Feature image, stock.adobe.com
This story originally ran in our October issue. For more stories like this, subscribe to Northern Virginia Magazine.
