Every Minute Matters: Enrolling in Studies While Living With Metastatic Breast Cancer
Camille Scheel is a Living Beyond Breast Cancer Hear My Voice Outreach Volunteer and author of Camp Chemo: Postcards Home from Metastatic Breast Cancer. For Breast Cancer Clinical Trials Matter to You, Camille shares her experience participating in a clinical trial for PARP Inhibitors.
Two months ago, I was literally jumping up and down with joy. I learned I had been accepted into a clinical trial! It’s what I’d been wanting for such a long time. More than a year ago I heard about the trial and switched oncologists hoping to get into this very trial.
The trial is for a class of drugs called PARP Inhibitors. These drugs work for individuals with BRCA mutations. Years ago I started reading about PARP Inhibitors, and knowing I was BRCA positive, I thought this drug would work for me. When I first tried to get into the trial I didn’t fit the criteria. The problem was I’d received too many cytotoxic treatments already. More than a year later, my oncologist told me the criteria had changed, and now I qualified for the EMBRACA study and the drug I’m taking is talazoparib. This is a phase III clinical trial of a PARP Inhibitor. Phase III means the drug has already been studied in humans for safety, efficacy, and now is being compared to existing treatments.
My geneticist was the first to tell me about PARP Inhibitors. So I started Googling them. Truth be told it kind of became stalking – I was seeking any information I could about PARP Inhibitors, including trials. When I learned from ClinicalTrials.gov that an oncologist in my practice was involved in a PARP study, I switched oncologists in hopes of getting into the trial. When I didn’t qualify based on the number of cytotoxins I’d already received, I was so upset. But a year later, the study investigators were not getting enough enrollment, which made them loosen up their criteria, allowing me to qualify.
This is my first clinical trial and so far the study drug is working for me. My disease is stable. The side effects are minimal compared with other MBC treatments I’ve received. Given the chance to participate in another trial, I would do so in a heartbeat. Even if I were randomized to the control (standard of care) group, I’d still participate because it’s so important for studies to be completed in a timely manner in order to get treatments to the market faster. Living with mets, we don’t have much time, so every minute matters.
The first step was qualifying on paper, but next I had to undergo many tests that I wouldn’t normally have needed for an FDA-approved drug. They required CT scans, bone scans, an EKG, and many, many vials of blood. More blood than normal. There was also a urine test, which surprised me – everybody wants my blood, but it’s been years since anyone’s asked for urine. I’m happy to pee in a cup for science.
When I was first diagnosed with MBC, my impression was that clinical trials were only for people who have exhausted all FDA approved treatment options. Now I understand the opposite is true. Clinical trials are a way to access the most cutting edge treatments.
One question people have asked is do I know if I’m receiving the trial drug. In this case, I do know I’m receiving the study drug. It’s important to understand that in clinical trials, you won’t be stuck with a placebo, meaning no care at all. Instead, if you aren’t randomized into the study drug group, you’ll receive a standard of care drug, which means you’ll receive the best option on the market that is now available. So before signing onto the trial, my oncologist and I selected a standard of care drug to use if I didn’t receive the study drug.
The study requires regular tests above and beyond my typical oncology appointments. For example, I need to have a blood draw every week along with a nurse taking my vital signs. Normally I’d only go to the clinic monthly, so it is more time, driving and money for gas. All of my medical expenses and the drug itself are covered by the study.
The biggest concern I’ve had is getting kicked out of the study. One week my white counts were down, so they had to reduce the dosage. Another week my hemoglobin was so low that to stay on a study I needed a blood transfusion. Again, the dose was reduced. I have two more dose reductions before I’m reduced off the study.
Anyone living with mets has benefitted from clinical trials. While I worry about being reduced off the study, I keep focused on this – I’ve already had 2 months of progression-free survival with minimal side effects. And hopefully I’m helping scientific inquiry move forward. Participating in a clinical trial is a way to give back and help others benefit from the gift of time.
The study is still open to new participants. Visit ClinicalTrials.gov to learn more.
Watch Camille’s video of the moment she learned she was accepted into EMBRACA study:
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