As Breast Cancer Awareness Month concludes, attention is drawn to the history and impact of clinical trials in breast cancer treatment. National Breast Cancer Awareness Month was first recognized in October 1985 as a collaborative initiative between the American Cancer Society, the American Academy of Family Physicians, and AstraZeneca. The campaign aimed to raise awareness about breast cancer and generate funding for research and clinical trials.
According to Dr. Gary Thomas, board-certified medical oncologist and Medical Director at St. Joseph’s/Candler SC Cancer Specialists, advancements in clinical research have contributed significantly to reducing breast cancer mortality rates over the past four decades. “Over these last 40 years, and I think it’s mainly the result of clinical trials, there’s been a 40 percent reduction in the mortality rate of breast cancer,” Dr. Thomas said. “Clinical trials are the life blood of research and innovation for all diseases, especially breast cancer.”
Clinical trials are structured studies involving patients that help researchers discover new methods for diagnosing, treating, or preventing diseases while also seeking ways to improve patients’ quality of life. These studies often evaluate drugs, medical devices, screening techniques, behavioral changes, and other interventions.
The Nancy N. and J.C. Lewis Cancer & Research Pavilion (LCRP) takes part in various clinical trials addressing multiple types of cancer. By offering these opportunities locally, LCRP allows patients access to cutting-edge treatments without leaving their community.
Dr. Thomas highlighted how previous breakthroughs have stemmed from such research efforts: “Without clinical trials, we would be stuck in the mud. We wouldn’t have hardly any advancements,” he said. He noted that Taxol—a drug discovered through clinical trials—has cured many patients since its introduction during his fellowship training.
He also referenced progress with immunotherapy: “Same thing for immunotherapy. We really didn’t know how that was going to go, and there are many, many patients – thousands of patients throughout this country – that had stage four cancer that absolutely would have died without participating in clinical trials for immunotherapy in certain cancers.”
Currently, St. Joseph’s/Candler is among only 13 facilities nationwide invited by the American Society of Clinical Oncology (ASCO) to participate in its CDK4/6 Inhibitor Dosing Knowledge Study (CDK). This trial seeks optimal dosing strategies for HR+/HER2- metastatic breast cancer patients aged 65 or older who have not previously received CDK4/6 inhibitors—a class of drugs targeting specific proteins to inhibit cancer cell growth.
Dr. Thomas explained the study’s focus: “The way drugs were developed until recently is you tried to give the patient the highest dose possible before they got super sick, so you weren’t really looking at what’s the lowest dose you can give them that would be effective and yet still tolerable,” he said. “The drugs in this trial have already been approved and used in clinical practice. We see that it seems like in many patients when you lower the dose anyway, the outcomes are very similar. This study is proof of concept.”
The CDK Study aims to enroll 500 post-menopausal women but remains early in its recruitment phase.
Jo Frayler from Sun City is one participant currently enrolled in this trial after being diagnosed with metastatic breast cancer earlier this year—her third occurrence since her initial diagnosis in 2005. She shared her experience: “When they first mentioned clinical trial, I thought, ‘You mean I could get a placebo?’ They said no,” Jo recalls. “The drug has already been approved for treatment. This study is looking at dosage.”
She was assigned a regimen of 125 milligrams of IBRANCE—one of two drugs tested—in daily cycles followed by rest periods each month.
“I think I’ve been doing very well on it,” Jo says. “I’ve had two PET scans since March. Both of them show significant decrease in the size of the lesions and nothing new anywhere.”
Jo reported minimal side effects: some mouth sores treatable with medication and altered taste preferences resulting in modest weight loss.
“Otherwise, I have no pain. There’s really nothing negative I can say about this form of treatment,” she said. “Dr. Thomas and the team there have always been honest about everything. I can ask them a question, and they give me honest answers.”
She added: “I know the goal is to treat this like something that can be maintained, like diabetes or heart disease. We’ll see. I have to be hopeful.”
