First Patient Enrolled in ASCO's Multi-State CDK Study for Older Adults with Metastatic Breast Cancer

Sites now enrolling in Arizona, Florida, Georgia, and South Carolina

Alexandria, Va. - The American Society of Clinical Oncology (ASCO) has launched the CDK4/6 Inhibitor Dosing Knowledge (CDK) Study to investigate personalized dosing strategies for CDK4/6 inhibitors in older adults with metastatic breast cancer. 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 is comparing 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."

The study is actively enrolling patients at sites across the United States, including Ironwood Cancer & Research Centers in Phoenix, Arizona; Miami Cancer Institute at Baptist Health South Florida; and three St. Joseph's Candler locations, including Savannah, Georgia; Bluffton, South Carolina; and Hilton Head Island, South Carolina.

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), an independent nonprofit organization authorized by Congress with a mission to fund patient-centered comparative clinical effectiveness research.

To ensure broad access to this research, 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.

Patient advocates have played a crucial role in shaping the design and implementation of the CDK Study. "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 cancer research considers the unique needs of this population, and I'm encouraged by ASCO's commitment to inclusivity and patient-centered care."

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

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.