News

The American Society of Clinical Oncology (ASCO) has launched the CDK4/6 Inhibitor Dosing Knowledge (CDK) Study, and three St. Joseph’s/Candler locations are among the first sites in the country enrolling patients: the Nancy N. and J.C. Lewis Cancer & Research Pavilion in Savannah, GA, and St. Joseph’s/Candler SC Cancer Specialists in Bluffton, SC and Hilton Head Island, SC.

The study investigates personalized dosing strategies for CDK4/6 inhibitors in older adults with metastatic breast cancer to improve outcomes and enhance quality of life. These patients often face unique challenges with treatment tolerability and adherence, and this trial aims to explore whether personalized dosing regimens can improve outcomes and quality of life.

“This study tackles a real-world problem that we see our patients face daily,” said Dr. Leonard Henry, medical director for the Lewis Cancer & Research Pavilion and principal investigator for this study. “This is exactly the type of clinical trial that the Lewis Cancer & Research Pavilion can attract to our area. We have a plethora of clinical trial research going on here and it’s part of the reason why we say that you don’t have to leave Savannah and the Low Country to get the best cancer care.”

Read more about the CDK trial

Call 912-819-5723 for more information

This study is investigating two different approaches:

• Titrated Dosing: Patients start with a low dose of a CDK4/6 inhibitor (palbociclib or ribociclib), which is gradually increased as tolerated.
• Standard Dosing with Dose Reductions: Patients begin with the standard FDA-approved dose, and the dose is reduced as tolerated.

  This comparative approach seeks to determine whether adjustments in dosing may help achieve these goals.

“This trial addresses the unique challenges faced by older adults with metastatic breast cancer,” said Dr. Julie R. Gralow, ASCO’s Chief Medical Officer and Principal Investigator of the CDK Study. “By optimizing dosing strategies, we aim to deliver more effective, personalized care that prioritizes patient safety and quality of life.”

Led by Dr. Gralow, Dr. Dawn L. Hershman (Columbia University), Dr. Erica L. Mayer (Dana-Farber Cancer Institute), and Patient Advocacy Lead Janice Cowden (Patient-Centered Dosing Initiative), this patient-centered trial, which includes broadened eligibility criteria, is funded by the Patient-Centered Outcomes Research Institute (PCORI), which supports research to improve patient care.

“As a patient advocate, I've seen firsthand the challenges older adults face when it comes to tolerating these treatments. This study aims to identify personalized dosing strategies that may improve quality of life and help people stay on life-extending therapies,” said Cowden. “It's crucial that research considers the unique needs of this population, and I'm encouraged by ASCO's commitment to inclusivity and patient-centered care.”

ASCO is in the process of opening the study at 13 centers at 73 locations across the US by early 2025; the need for additional sites will be reassessed later in 2025. ASCO is dedicated to advancing cancer research and encourages interested sites to reach out and learn more about opportunities to collaborate on future studies and initiatives.

“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.”

For more information about the CDK Study, please visit ASCO’s CDK Study webpage.

About ASCO:

Founded in 1964, the American Society of Clinical Oncology, Inc. (ASCO®) is committed to the principle that knowledge conquers cancer. Together with the Association for Clinical Oncology, ASCO represents more than 50,000 oncology professionals who care for people living with cancer. Through research, education, and promotion of high quality, equitable patient care, ASCO works to conquer cancer and create a world where cancer is prevented or cured, and every survivor is healthy. Conquer Cancer, the ASCO Foundation, supports ASCO by funding groundbreaking research and education across cancer’s full continuum. Learn more at www.ASCO.org, and follow us on Facebook, X, LinkedIn, Instagram, and YouTube.

About the Nancy N. and J.C. Lewis Cancer & Research Pavilion at St. Joseph’s/Candler:

The Nancy N. and J.C. Lewis Cancer & Research Pavilion (LCRP) at St. Joseph's/Candler is where advanced technology and compassionate care combine to create one of the most innovative clinical oncology programs in the Southeast. The LCRP is home to a team of highly trained cancer specialists that skillfully use high-impact technological screening and treatment options for optimal results. In addition, our team has access to nationally funded research and clinical trials and provides community outreach and education with an outstanding array of services specific to cancer patients and their families.

The LCRP has a robust clinical trials program and participates in state, regional and national collaborations with other research sites including a national collaboration with the National Cancer Institute's Community Oncology Research Program (NCORP).

The LCRP has expanded into the region to make it easier for our patients, with a campus in Bluffton, S.C. and infusion practices in Hinesville, Jesup, Pembroke and Statesboro.