As Breast Cancer Awareness Month concludes, the history and progress of breast cancer research are in focus. The first National Breast Cancer Awareness Month was recognized in October 1985, initiated by the American Cancer Society, the American Academy of Family Physicians, and pharmaceutical company AstraZeneca to increase awareness and funding for research and clinical trials.
Dr. Gary Thomas, a board-certified medical oncologist and Medical Director at St. Joseph’s/Candler SC Cancer Specialists, emphasized the impact of clinical trials on patient outcomes 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 involve patients in studies designed to improve diagnosis, treatment, prevention strategies, and quality of life for those with diseases. These studies test drugs, devices, screening methods, behavioral changes, and other interventions.
The Nancy N. and J.C. Lewis Cancer & Research Pavilion (LCRP) participates in a range of clinical trials across different cancer types focused on diagnosis, treatment, or prevention. By conducting these studies locally at LCRP, patients can access new treatments while contributing to ongoing research within their community.
“Without clinical trials, we would be stuck in the mud. We wouldn’t have hardly any advancements,” Dr. Thomas said. He noted that Taxol—now widely used—was developed through such research efforts: “When I was in fellowship training, the drug Taxol had just came out. There are now so many people that are cured as a result of that drug, which we discovered through clinical trials.” He also highlighted advances from 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, LCRP is among 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 involved in cancer cell growth—to determine if lower starting doses reduce side effects while maintaining effectiveness.
“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,” Dr. Thomas explained. “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 study recently began recruiting participants; results are not yet available as enrollment continues toward its goal of 500 post-menopausal women.
Jo Frayler from Sun City is one participant who has chosen to join after her third diagnosis with breast cancer earlier this year resulted in metastasis to her bones. After consultation with Dr. Thomas at St. Joseph’s/Candler SC Cancer Specialists—and learning she would receive an approved medication rather than a placebo—she entered into randomized dosing for IBRANCE as part of the trial.
“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.”
Since beginning daily oral therapy with IBRANCE at 125 milligrams on a three-week-on/one-week-off schedule determined by random assignment within the study protocol—Jo reports positive progress: “I think I’ve been doing very well on it,” she said regarding recent scans showing reduced lesion size without new spread.
She notes manageable side effects such as occasional mouth sores and taste changes but remains optimistic about her treatment experience: “Otherwise, I have no pain. There’s really nothing negative I can say about this form of treatment,” Jo says. “Dr. Thomas and the team there have always been honest about everything. I can ask them a question, and they give me honest answers.”
Reflecting on living with metastatic disease under current therapies made possible by prior research efforts—including those conducted through local institutions like LCRP—Jo adds: “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. You can’t live in a negative state all the time.”
