Suzanne Garner, 48, was diagnosed with stage II breast cancer in 2019. After a lumpectomy and 30 rounds of radiation, the resident of Encinitas, California, assumed she’d beaten the disease for good. But a conversation with her oncologist startled her.
“He explained that my type of breast cancer — hormone [receptor] positive, HER2-negative — had a 30% chance of recurrence,” Garner says. “I walked out of his office feeling very deflated.”
Garner was already on hormone therapy to help lower the risk of her breast cancer returning, but she wondered if there was more she could do. After a bit of online research, she learned of the NATALEE clinical trial, which tested a CDK4/6 inhibitor called ribociclib for people with early-stage ER-positive breast cancer. Even though the study was a two-hour drive away, Garner decided to enroll.
The trial was a success for both Garner and the drug. She’s still in remission, and the drug, called ribociclib (Kisqali), was FDA-approved in September 2024. It’s been shown to reduce the risk of recurrence in premenopausal women diagnosed with hormone-receptor-positive, HER-2-negative breast cancer by about a third.
“I feel lucky that I was able to get access to a drug that improved my own chances of survival,” Garner says. “But just as importantly, I was able to participate in ground-breaking clinical research that helped other breast cancer patients.”
Why Clinical Trials Are Important
The goal of clinical trials is to find new ways to prevent, diagnose, and treat diseases.
“I tell my patients that when they participate in a clinical trial, they play an important role in defining what the standard of breast cancer care will be in a few years,” says Benjamin Smith, MD, a breast cancer radiation oncologist at the University of Texas MD Anderson Cancer Center in Houston, Texas.
But it also helps to ensure that you’re getting cutting-edge treatment.
“Oftentimes, patients are first in line for what will ultimately turn out to be the best treatment option for their type of breast cancer,” Smith says.
There are several types of clinical trials. When it comes to breast cancer, treatment trials are the most common. These trials study new treatments, new combinations of medications, and new ways to approach surgery or radiation.
“Unlike other clinical trials, breast cancer patients aren’t given a placebo, or no treatment,” Smith says. “The trials always compare these new treatments or therapies against the current standard of care.”
Elizabeth Ponder, 34, a resident of Flatonia, Texas, joined a study at MD Anderson Cancer Center two years ago when she was diagnosed with triple-negative breast cancer.
“When my breast cancer team first explained the trial to me, I was nervous. I thought clinical trials were something you only did when you ran out of other options,” Ponder says. “It didn’t make sense to me, since I knew other very effective treatments were available. But my doctors explained that I’d be getting the same recommended treatments but in a different order to make my breast cancer treatment shorter and easier.”
Ponder participated in the TOPAz trial, which compares the outcomes of two different radiation therapy schedules.
“Usually, patients have a tissue expander placed during their mastectomy, followed by six weeks of daily radiation therapy, and then breast reconstruction 6-12 months later,” Smith says.
But about 1 in 5 women experience complications with the tissue expander and need to have it removed while they wait for their second breast surgery.
“In the TOPAz study, we want to compare outcomes in women who start with radiation, then have mastectomy and breast reconstruction at the same time, with women who follow the traditional radiation schedule,” Smith says.
Ponder was one of the patients chosen to have radiation first, followed by both surgeries at once.
“I’m glad I decided to join. I’ve been cancer-free since February 2024, and it also cut the number of surgeries I needed in half,” Ponder says. “It also makes me very happy to know my doctors will use what they’ve learned from me to make treatments for other breast cancer patients even better.”
What to Expect in a Clinical Trial
You can’t just walk into a clinical trial. First, you have to qualify. And if you do, that’s just the beginning. The process generally goes like this:
Prescreening. The medical professionals who run the trial will ask a series of questions either in person or over the phone to make sure you’re a good fit.
Informed consent. The medical professionals running the study will walk you through an informed consent document. It explains:
- Trial goals
- Risks and potential benefits
- Any experimental treatments used in the trial
- Length of trial, including follow-up
- Expected costs to the patient
- Whether the trial is randomized (this is important information to know if you want to join the trial to try a new treatment)
Screening. Once you sign the informed consent document, they’ll look over your medical history and run more tests to make sure it’s safe for you to participate.
Trial participation. You’ll meet regularly. How often depends on the type of trial and what treatment and procedures are involved. It can be a big time commitment.
“The first year of my clinical trial, I had to make a two-hour drive to the center once a week,” says Garner. “My employer was very understanding, but I still had to take work calls in the car and bring my laptop to do work while I waited to see the doctors. There was one time when I took an important Zoom call with a client in the janitor’s closet because that was the only quiet place in the hospital.”
If the trial is in another state, you may have to temporarily relocate. They may be able to reimburse you for your time and/or cover some of your travel, transportation, and hotel costs.
Once the trial is over, you may be able to stay on the treatment. You’ll work with the trial team and your regular health care team to figure out the next steps.
How to Manage Your Emotions During a Clinical Trial
It’s normal to feel a range of emotions when you join a clinical trial. You may be hopeful, but you might also feel scared and anxious.
“When I started to take Kisquali, my hair began to fall out,” Garner says. “I felt ugly and depressed, while I grappled with worries that I would die and leave my 5-year-old daughter motherless. But I also felt hope, too.”
Here is some advice to help you navigate this time:
Join a support group. Most centers that sponsor clinical trials also offer breast cancer support groups. You can also find local and online support groups through organizations like the National Breast Cancer Foundation, the American Cancer Society, and the Susan G Komen Foundation.
Consider talk therapy. The location your clinical trial is being conducted at may have psychologists, oncology social workers, or psychiatric nurses you can speak to. You can also ask for recommendations from other breast cancer patients. Look for a therapist who has experience working with people with cancer. “I invested in weekly therapy, and it was one of the best decisions I made throughout the clinical trial process,” says Garner.
Practice mindfulness. You might find techniques like deep breathing or progressive muscle relaxation helpful. The American Cancer Society has suggestions here.
Lean on family and friends. “I was blindsided by my breast cancer diagnosis, and nervous about the clinical trial, but the fact that I had family so close by and such a strong local support network really helped,” says Ponder. “It can be as simple as loved ones checking up on you and bringing you a meal.”
How to Find a Clinical Trial
If you’re being treated at a major cancer center, your health care team may bring up clinical trials at your first visit. But if they don’t, there may still be some that are a good fit for you.
“When I first found the NATALEE trial, I brought it up with my breast cancer doctor who told me I wasn’t a candidate for it,” says Garner. “But when I pulled up the participation criteria for the study, he quickly realized that I was. If I hadn’t done research on my own, I would never have found it.”
One of the best places to look for clinical trials is clinicaltrials.gov. It’s a website run by the National Institutes of Health. You can search by breast cancer stage, type of breast cancer, and other specifics. Smith recommends clicking on the contacts and location button if you find a trial that looks promising. Many trials have the names, phone numbers, and emails of the chief researchers.
“I get emails all the time from patients or their caregivers across the country, and I always personally respond to them within a few days,” Smith says. “Even if the trial isn’t a fit for them, I can sometimes guide them to other potential clinical trials.”
