“It delivers the chemo more directly into the cancer cells with less effect on the healthy cells,” said Dr. Taral Patel, one of the oncologists conducting the study. “You don’t see the hair loss and vomiting and other side effects. We have multiple patients who have been on the drug for two years without the disease progressing.”
The clinical trial has been going on for five years and the TDM1 drug could be available as early as December, offering hope to thousands of breast cancer patients.
“I feel better than I have in the last couple years,” said Frazier, a Dayton native and mother of two young children who now lives in Columbus. “I am not in pain and I’m not fatigued. So many of the drugs are extremely toxic, and you are constantly tired or sick and lose your hair. You really live a very high-quality life.”
That’s incredibly important for the advanced-stage cancer patient, observed Frazier: “Treatment is the constant in our lives. It’s terrible to go through that while being miserable. Being able to live a high-quality life is what makes this drug a superstar.”
Ohio State University’s Arthur G. James Cancer Hospital, commonly known as “The James,” is at the forefront of breast cancer research, currently conducting 15 clinical trials.
Dr. Maryam Lustberg knows all of the stereotypes about clinical trials in medicine: The patients are guinea pigs. They’re advancing medical research, but they may not be advancing their own recovery.
In reality, clinical trials can provide some of the most promising treatments for patients with advanced-stage breast cancer, said Lustberg, a breast oncologist at The James.
“Multiple studies have shown that patients treated with clinical trials have better outcomes,” she said. “Their cases are so carefully monitored, with multiple people reviewing their labs, and they’re experiencing the best and newest trials. We believe all patients will benefit. Clinical trials aren’t designed to take away options, but to add to standard therapy options.”
Dr. Patel of the Zangmeister Center concurred many patients undergoing clinical trials, such as TDM1, are living longer with fewer toxic side effects.
Clinical trials carry very little risk, Lustberg said, because they are typically used in tandem with established treatments.
“They are safely designed not to take away options, but to add to standard therapy options,” she said.
The research is bringing new hope to patients such as Cindy Murrish, 58, of Columbus.
Two years ago, Murrish was diagnosed with metastatic triple negative breast cancer. An aggressive tumor had invaded her sternum and lungs and gotten close to her heart. “They said I might have a year to live,” she said.
Murrish immediately started doing her own research and decided to seek a second opinion.
“That’s what a lot of women don’t do,” she said.
She felt encouraged after her first appointment with Lustberg.
“She told me, ‘We can treat you, and we’ve had good results with clinical trials,’” Murrish recalled. “She was very compassionate, and she really explained everything. She took her time.”
Most recently, Murrish has been part of a promising clinical trial involving Parp inhibitors.
“We tested her tumor tissue for protein that targets DNA repair,” Lustberg explained. “The Parp inhibitors target other repair pathways in the tumor cells, and the tumor cells essentially die.” As with the TDM1 trials, this drug is showing low toxicity.
The cancer in her sternum and chest are now shrinking, Murrish said: “I am very hopeful. At The James, they do give you hope.”
In addition to advancing her own recovery, Murrish said, she feels good about advancing breast cancer research. “There is so much new advancement, and I’m excited to be part of it,” she said.
Kristi Frazier also feels that sense of satisfaction. But her more urgent concern is being able to take care of her children.
In May 2007, Frazier had recently married her husband, Dustin, when she was diagnosed with Stage 2B breast cancer that had spread to her lymph nodes. Two weeks later, she found out that she was pregnant.
She delivered a healthy daughter, Addison, now 4. After her birth, Frazier underwent 35 rounds of radiation and intensive rounds of chemotherapy, and by Christmas of 2008 her cancer was in remission. The couple’s son, Chase, was born in January 2010.
In April, 2011, Frazier was diagnosed with Stage 4 metastatic breast cancer, which had spread to her lungs, liver and brain. She underwent 12 rounds of Whole Brain Radiation, her lifetime limit.
For a time, Frazier decided to forego traditional medical treatments so she could live her life more fully. When she learned about the TMD1 trial, she very much wanted to be part of a clinical trial that would enable her to get back to full-time parenting.
“Prior to starting this drug, I had help 24 hours a day with my children,” Frazier said. “I was on the sidelines. I had to have constant help because I never knew when I would get tired or be in pain. I appreciated all the help I could get, but I was never alone with my kids. I am the Mom, and I want to take care of my kids.”
Now she’s regaining much of her independence and parental control, thanks to the clinical trial taking place in her backyard. Now her days are filled with outings to dance class and gymnastics.
“I am running them back and forth just like I always wanted to,” she said. “I am exhausted at the end of the day, but then again, so are all parents.”
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