From ‘doing less’ to immunotherapy, clinical trials offer patients new options
Women in the United States have a 1-in-8 chance of being diagnosed with breast cancer, and the disease has garnered significant attention in recent years, with football players donning pink socks and women running 5K races to raise money for research.
And yet, despite being a familiar disease, the treatment process can be complicated with a lot of unknowns. Traditional surgery and therapies are often aggressive and can have harsh side effects. For these reasons, researchers are constantly exploring new ways to treat breast cancer and enlisting volunteers to participate in clinical trials.
Locally, Dr. William J. Irvin Jr., medical director of medical oncology for Bon Secours Health Systems Virginia and director of clinical research at the Bon Secours Cancer Institute at St. Francis Hospital, oversees clinical trials to treat breast cancer. These trials are tests on current cancer patients to see how effective new treatments are, many of which are less invasive than older and more established radiation and chemotherapy courses and major surgery. “Trials are the only ways we’ve improved the lives of people with cancer,” Irvin explains.
The U.S. Food and Drug Administration sets up phases of a clinical trial, with tests going through different phases before being approved. Pharmaceutical companies, hospitals, organizations and federal agencies all fund such studies, which are usually conducted by doctors or other health care providers, according to the National Institutes of Health.
Irvin says women who opt to participate in trials may do so because other treatments haven’t worked, because they desire access to emerging therapies or because they want to help others through advances in research. The major benefit for patients participating in a clinical trial, he says, is that “you’re watched extremely closely,” with a research nurse assigned to each patient to test her condition on a regular basis. “Also, you’re potentially getting tomorrow’s therapy today.” And, most significantly for Irvin, trials allow future cancer patients to receive better treatment.
Irvin calls one group of trials “doing less,” such as taking out just a malignant lump, instead of removing the entire breast and underlying muscle. Another trial tests how exercise and weight loss prevent breast cancer from returning, with participants teamed with coaches.
Currently, there is a lot of focus on immunotherapy, such as strengthening T cells to fight mutating cancer cells. Doctors also are testing the effect of chemotherapy before surgery, as well as whether daily aspirin use can keep cancer from returning. At the moment, Bon Secours Health Systems has 13 active breast cancer clinical trials.
Nancy Vacca is one of Irvin’s patients. Diagnosed with breast cancer in 2016, Vacca started on conventional cancer drugs, but when a small cancerous spot turned up on her spine, it became clear the treatment wasn’t working. Now she is taking oral chemotherapy medication – one pill a day and a second pill weekly.
So far, it appears to be working, says the 79-year-old Woodlake resident, a former nurse. Taking pills at home is more convenient than going to a clinic for traditional IV infusions, she says, adding that she visits Irvin every three months for a scan. During her visits to Bon Secours, she sees patients who seem much sicker than she is, a reminder that each case is unique.
Breast cancer is an umbrella term for several different types of cancer, some more serious than others, Irvin notes. Your friend or family member’s course of treatment may be completely different from yours, so it’s important to ask your doctor or nurse about the best path forward.
“I’m very fortunate,” Vacca says. “I can only speak from my perspective. Traditionally, you’re very sick. … The oral chemo that I’m on is, to my world, totally different.”
Vacca, like many patients in trials, was offered the option of participating by her doctor. There are online resources, such as clinicaltrials.gov or clinicaltrialsbsva.com (Bon Secours’ site), that give detailed information about active trials, but Irvin cautions that they’re written for health care professionals and not for the layperson. He says asking your doctor is a better way to find out if you’re suited for a clinical trial.
“Explore your options. Ask questions,” Vacca advises.
Like many women, Nancy Hall, another patient of Irvin’s, let her own health lapse while taking care of a loved one. Her husband was terminally ill, and although Hall noticed a lump in her breast in 2016, she didn’t seek help until it had become a large, open wound, in 2017.
Hall’s tumor had to shrink before Irvin could operate, so she went through a course of chemo and radiation, which caused her to lose her hair. Along the way, she became severely dehydrated and developed an allergy to one of her medications.
But today she is improving in her clinical trial, in which she receives a lower dose of chemotherapy every three weeks to prevent cancer from returning, with no significant side effects. “I’ve been through surgery, chemo, radiation, the whole nine yards,” the great-grandmother from North Chesterfield says. “I’m lucky to be alive.”
“The clinical trials have been easy,” she says of the lower-dose chemo infusions. “I’ve had no side effects from it. This is a piece of cake. I’m much better than I’ve been in the past two years.”
Both Hall and Vacca mention that the accessibility of Irvin and staff nurses is important; they’re available to answer questions in person or by phone.
“It’s an overwhelming amount of information that gets thrown at you,” Irvin says.
Only about 5 percent of adult cancer patients participate in clinical trials, Irvin says. One reason for this is time – a trial can potentially take longer to put cancer into remission, or simply may not work for a patient. Other patients are concerned about undergoing more biopsies, which can be painful or inconvenient, or receiving placebos instead of medication, Irvin adds. Those who choose to take part often do so because it’s the best option according to their doctor’s advice, perhaps after another treatment has failed.
Historically, older patients and people of color have been underrepresented in clinical trials, and specifically for breast cancer, homosexual women have also been overlooked. There are several reasons for this, Irvin says, including historical harm – such as the infamously unethical Tuskegee Syphilis Study of African-American men – and a lack of access to health care among minority populations.
Today, he says, doctors are working to be more inclusive in their trials, by educating patients and offering information in multiple languages. However, hospitals must invest heavily in trained personnel and organizational infrastructure so each patient receives enough individual attention and one-on-one guidance, Irvin notes.
Hall says that although patients sometimes feel fearful about trying something new, “If people didn’t go through clinical trials, none of us would be better. Clinical trials help all of us. I feel better than I have in several years.”
Barbara Jacoby is an award winning blogger that has contributed her writings to multiple online publications that have touched readers worldwide.