The problem: Sometimes women can’t tolerate their breast cancer treatment. A possible solution: The CDK Study.

Lewis Cancer & Research Pavilion one of first centers in the country to participate in ASCO’s CDK Study to look at dosing levels of certain medications in women with metastatic breast cancer

Are you 65 or older with HR+/HER2- metastatic breast cancer? If you haven’t had prior treatment with a CDK4/6 Inhibitor, we have a groundbreaking study we want you to know about.

It’s the American Society of Clinical Oncology (ASCO)’s CDK4/6 Inhibitor Dosing Knowledge Study (CDK). The Nancy N. and J.C. Lewis Cancer & Research Pavilion is one of the very first cancer centers in the country to be asked to participate in this study.

“This was a study we had interest in almost immediately,” says Dr. Leonard Henry, medical director for the LCRP and principal investigator for this study. “Mostly because this is a real-world problem which happens to our patients daily, and also this is a novel study design for the future of drug delivery and symptom management.”

The CDK Study aims to find the best CDK4/6 dosing strategy in certain breast cancer patients. (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.  

To be eligible to participate, you must be:

• At least 65 years old
• Have HR+/HER2- metastatic breast cancer
• Not received previous treatment with a CDK4/6 inhibitor for metastatic breast cancer

“This study is important for several reasons: It applies to a large number of patients; it is a unique trial design; and it is seeking to optimize drug dose which has implications for medication adherence as well as toxicity management,” Dr. Henry says.

How it works

Eligible patients and their doctor will select a study medication: palbociclib or ribociclib – both already FDA-approved oral medications for breast cancer treatment. They will also choose an endocrine therapy, which is standard for treating this type of breast cancer, says Stephanie Reyes, manager of oncology clinical research, CCDR and trials at the LCRP.

At random, some patients will start at a lower dose of the selected oral medication and gradually increase to a higher dose as tolerated. Other participations will begin with the FDA-approved recommended starting dose.

“This study really looks at dosing and dosing knowledge that will be gained from the patients that participate,” Reyes says. “We’re looking at side effects, the patient’s quality of life and time to treatment discontinuation.”

The CDK Study is available to qualified patients at our Savannah, Bluffton and Hilton Head locations. It doesn’t require extra imaging or labs. You will be asked to complete surveys about your health and the treatment your receive during the study.

“If this study turns out to be positive this could potentially change dosing strategies for these particular drugs in women with breast cancer but it also might spur additional trials of additional cancer sites with different drugs with the same goal of optimizing treatment dosing,” Dr. Henry says.

“I would encourage women over 65 to participate in the study to help us learn the optimum way to dose these drugs,” Dr. Henry says. “If we can create a better strategy for dosing that allows patients to stay on these effective drugs longer than that will be of benefit to them and other patients as well.”

About the LCRP’s clinical trial program and ASCO

The LCRP participates in numerous clinical trials for all cancer types regarding diagnosing, treating or preventing. This is the second clinical trial from ASCO that the LCRP is participating in. The first being the TAPUR trial, which the LCRP is very proud to have been selected for, Reyes says.

The ASCO is committed to making a world of difference in cancer care and represents more than 50,000 oncology professionals who care for people living with cancer. Learn more at www.asco.org.

If you are a qualified metastatic breast cancer patient and are interested in the CDK Study, please talk to your healthcare provider.