Listen to HER2: I feel ‘dang lucky’ to have been in a clinical trial

In 2015, at age 47, Kimberly Wooten was diagnosed with HER2-positive stage II breast cancer that continued growing despite pre-surgery chemotherapy. That made her eligible for a phase III clinical trial called KATHERINE, which she joined. Trial participants were randomly assigned standard treatment with trastuzumab (Herceptin) or treatment with the experimental medicine TDM-1 (Kadcyla) so researchers could learn which treatment prevents more recurrences. TDM-1 is a combination of trastuzumab and a chemotherapy medicine. It is FDA-approved for breast cancer that is HER2-positive and metastatic, but not early-stage.

Kimberly was done with her trial treatment in September 2016. For Listen to HER2, she answers questions about participating in a clinical trial of a HER2-targeted therapy in a Q&A with LBBC writer and content coordinator Erin Rowley.

Erin: How did you hear about the KATHERINE trial?

Kimberly: The day I met with the surgeon, before chemo even started, she was discussing this "wonderful" clinical trial for HER2-positive breast cancer and how lucky I was that I might be able to participate in it. This was before I'd even had my first round of chemo – surgery and radiation and more chemo came later. My first thought was utter suspicion because the clinical trial was for women whose chemo treatment hadn’t shrunk their tumor. Why would they recommend this to me? Why be happy about it? To me, it seemed as if they were setting my treatment up to fail – which it did in the end, as the chemo didn’t shrink my tumor – and they seemed excited about it!

Erin: Since the pre-surgery treatment didn’t kill all of the cancer cells, you became eligible for the trial. Why did you decide to participate?

Kimberly: Short answer: I didn't want to die. My tumor grew through 5 months of chemo. It went from 4 centimeters to 6 centimeters, as if the chemo was chocolate cake. My doctor basically said this was my best option for survival.

Erin: Did you have any concerns about participating in a clinical trial?

Kimberly: Yes, I was worried it wasn't "real," meaning it was somehow not really intended to help women like me. It's hard to explain, but I felt like I would be a guinea pig and that the hospital and the pharmaceutical company wouldn’t have my best interests at heart. And at a basic level, I didn't want to go through any more chemo, even chemo that was going to be "easy" to tolerate.

Erin: Do you know if you received the standard treatment (trastuzumab alone) or the study treatment (TDM-1)?

Kimberly: My doctor was thrilled when she found out I was going to receive TDM-1 … and her excitement helped me. The other group received Herceptin only, which is the standard treatment. I hope most of them did well.

[Editor’s note: Results from the KATHERINE trial are not yet available.]

Erin: Was your treatment experience different in the clinical trial than it was prior to the trial?

Kimberly: Yes! It was so much better! I think that was mostly due to my wonderful clinical trial nurse who was with me for 14 months. She was kind, positive, accommodating, understanding and funny. Plus, I'm still alive, and I don't think I would be otherwise. I was able to watch my daughter, who is very shy, sing the lead role in Mary Poppins. I was able to see my son graduate from eighth grade and my daughter graduate from high school and be accepted to California State University, Fullerton for dance. I'll be able to see my son play on his first high school football team. This is all amazing to me!

Erin: Did you experience any side effects?

Kimberly: The side effects of the TDM-1 were minimal. I was definitely tired for the 5 days following the infusion, but I was able to maintain a 20-hour work week despite the discomfort. The hardest thing was I developed nausea because of the infusion itself, meaning the smell of the antiseptic, the puncture of the needle into the port – just being in the room. In addition, they test your heart on a regular basis, as the treatment can be very tough on it. I was fine, but that test also made me want to vomit. With the exception of being ill one time, I managed to hold my cookies.

Erin: How does it feel to have gotten a treatment that isn’t normally available to people with early-stage breast cancer?

Kimberly: Dang lucky! Before I was diagnosed with cancer, I had no idea how clinical trials worked. … Once I looked at the bigger picture – my sister, my 17-year old daughter, my 16-year old niece … and women and girls I will never know – it was important to be part of the trial and possibly help move things closer to a cure. Ask me what I think about it in 10 years! Ha!

Kimberly Wooten is 49 years old. She lives with her husband, Scott Baxter, daughter, Sunday Baxter, and son, Inigo Baxter, in Jackson, California. Read more Listen to HER2 stories here.