St. Joseph’s/Candler is one of just a few select facilities in the country participating in ASCO’s CDK Study to look at treating metastatic breast cancer

As Breast Cancer Awareness Month nears the end, we thought we’d look back at how it began.

No, not Oct. 1, 2025, but October 1985 – the first year National Breast Cancer Awareness Month was recognized.

It started as a joint effort between the American Cancer Society, American Academy of Family Physicians and the pharmaceutical company, AstraZenca. The goal was to raise awareness of the disease and raise funds for research and clinical trials.

And it’s really made an impact.

“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,” says Dr. Gary Thomas, board-certified medical oncologist and Medical Director at St. Joseph’s/Candler SC Cancer Specialists. “Clinical trials are the life blood of research and innovation for all diseases, especially breast cancer.”

What is a clinical trial?

A clinical trial is a research study that involves patients and helps doctors and researchers find new ways to improve diagnosing, treating and preventing diseases, while also improving the quality of life for people with diseases. In clinical trials, researchers methodically test drugs, medical devices, screening approaches, behavioral modifications and other interventions.

The Nancy N. and J.C. Lewis Cancer & Research Pavilion participates in numerous clinical trials for all cancer types regarding diagnosing, treating or preventing. By offering clinical trials at the LCRP, you can get the latest treatment and help further cancer research in the comfort of your own community.

“Without clinical trials, we would be stuck in the mud. We wouldn’t have hardly any advancements,” Dr. Thomas says. “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.”

“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.”

The CDK4/6 Inhibitor Dosing Knowledge Study

One of the current breast cancer trials that the LCRP is honored to be participating in is the American Society of Clinical Oncology’s (ASCO) CDK4/6 Inhibitor Dosing Knowledge Study (CDK). St. Joseph’s/Candler is one of only 13 facilities in the country invited by ASCO to participate in this study.

The CDK Study aims to find the best CDK4/6 dosing strategy in HR+/HER2- metastatic breast cancer patients that are at least 65 years old and have not been treated with a CDK4/6 inhibitor previously. (CDK4/6 inhibitors are a group of medications that target a certain type of protein to stop the growth of cancer cells.) The goal is to see if starting at a lower dose helps patients tolerate the medication with fewer side effects, allowing them to stay on it longer.

“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 explains. “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 just recently began and is looking for 500 post-menopausal women to participate so it’s too early to see results from the study.

But one of Dr. Thomas’s patients who is on the trial feels very confident in her decision to participate.

‘Significant decrease in the size of the lesions’

Sun City resident Jo Frayler is facing her third battle with breast cancer. She was first diagnosed in 2005 and had a bi-lateral mastectomy with reconstruction. In 2014, after she moved to South Carolina, a lump with breast cancer cells was found in her pectoral muscle. She had it removed and underwent chemotherapy and radiation therapy. That’s when she met Dr. Thomas.

Unfortunately, the cancer returned at the beginning of 2025, this time it had spread to her bones. Dr. Thomas thought she’d be an ideal candidate for the CDK Study and put her on IBRANCE, one of the two CDK inhibitors the study is using.

“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 this is a randomized trial, Jo’s information was entered into a database, and it was determined she would get the highest amount, 125 milligrams of IBRANCE, which is an oral, hormone therapy drug. She takes it every day for three weeks and then has a week off.

“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.”

The side effects have also been very minimal, Jo says. She has occasional mouth sores, but has medication to treat them. She has experienced changes with her taste buds so her favorite foods don’t taste the same. But, she’s OK with that – she’s lost those nagging 15 pounds she’s always wanted to.

“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.”

“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. If you do so, then you are not enjoying the time that you are here.”

 

Coming Soon: Read more about Jo’s story in our LCRP cancer survivor series, “Ringing the Bell”