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CDK4/6 Inhibitors in Metastatic Breast Cancer

Panelists: Kimberly L. Blackwell, MD, Duke; Adam M. Brufsky, MD, PhD, University of Pittsburgh; Joyce A. O’Shaughnessy, MD, US Oncology; Mark D. Pegra
Published: Thursday, May 22, 2014
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Novel therapies targeting CDK 4/6 have generated considerable excitement as treatments for patients with ER-positive metastatic breast cancer. The combination of the CDK 4/6 inhibitor palbociclib with letrozole demonstrated significantly improved clinical outcomes in the phase II PALOMA-1 trial.

To further explore palbociclib, a phase III trial combining the drug with letrozole was opened in February 2013. In December 2013, the trial had already accrued 25% of the necessary patients, notes Hope S. Rugo, MD. Additionally, a trial is exploring second-line palbociclib with fulvestrant in women with HR-positive metastatic breast cancer.

In addition to palbociclib, a number of other agents are being investigated across several clinical trials. The CDK 4/6 inhibitor LEE011 has demonstrated promising activity in patients with refractory ER-positive breast cancer, notes Denise A. Yardley, MD. In future clinical trials, this agent will be explored in combination with the alpha-specific PI3K inhibitor BYL719.

Adding to the excitement for this class of drugs, CDK 4/6 inhibitors may also be active in HER2-positive breast cancer, suggests Joyce A. O’Shaughnessy, MD. A study is planned that will explore LEE011 in combination with T-DM1 as a treatment for patients with HER2-positive metastatic breast cancer, O’Shaughnessy notes.


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For High-Definition, Click
Novel therapies targeting CDK 4/6 have generated considerable excitement as treatments for patients with ER-positive metastatic breast cancer. The combination of the CDK 4/6 inhibitor palbociclib with letrozole demonstrated significantly improved clinical outcomes in the phase II PALOMA-1 trial.

To further explore palbociclib, a phase III trial combining the drug with letrozole was opened in February 2013. In December 2013, the trial had already accrued 25% of the necessary patients, notes Hope S. Rugo, MD. Additionally, a trial is exploring second-line palbociclib with fulvestrant in women with HR-positive metastatic breast cancer.

In addition to palbociclib, a number of other agents are being investigated across several clinical trials. The CDK 4/6 inhibitor LEE011 has demonstrated promising activity in patients with refractory ER-positive breast cancer, notes Denise A. Yardley, MD. In future clinical trials, this agent will be explored in combination with the alpha-specific PI3K inhibitor BYL719.

Adding to the excitement for this class of drugs, CDK 4/6 inhibitors may also be active in HER2-positive breast cancer, suggests Joyce A. O’Shaughnessy, MD. A study is planned that will explore LEE011 in combination with T-DM1 as a treatment for patients with HER2-positive metastatic breast cancer, O’Shaughnessy notes.
View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Community Practice Connections™: CDK4/6 Inhibitors With the Experts: The Role of Emerging Agents for the Management of Metastatic Breast CancerMay 30, 20182.0
Medical Crossfire®: Clinical Updates on PARP Inhibition and its Evolving Use in the Treatment of CancersMay 30, 20181.5
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