NATALEE: Ribociclib and Endocrine Therapy in HR+/HER2- Early Breast Cancer

EP: 1.Optimizing Adherence to CDK4/6 Inhibitors in Metastatic Breast Cancer

EP: 2.Institutional Insights on CDK4/6 Inhibitor Adherence in Breast Cancer

EP: 3.CDK4/6 Inhibitors as First-Line Options in Metastatic Breast Cancer

EP: 4.Treatment Algorithms for Early and Metastatic Breast Cancer

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EP: 5.NATALEE: Ribociclib and Endocrine Therapy in HR+/HER2- Early Breast Cancer

EP: 6.Evaluating the Impact of Metastatic Breast Cancer on Patients

EP: 7.Highlighting the Available CDK4/6 Inhibitors

EP: 8.Strategies to Enhance CDK4/6 Inhibitor Adherence in mBC

EP: 9.Applying NCCN Guidelines in the Treatment of mBC

EP: 10.CDK4/6 Inhibitor Sequencing and NCCN Guidelines in mBC

EP: 11.Evaluating CDK4/6 Inhibitor Safety Profiles: An Analysis of Adverse Events

EP: 12.Navigating Financial Barriers: Cost-Saving Strategies and Patient Assistance Programs

EP: 13.Exploring Therapeutic Alternatives to CDK4/6 Inhibitors in Metastatic Breast Cancer

EP: 14.Academic and Community Practice Collaboration in mBC Treatment

EP: 15.Defining the Standard of Care for Early Breast Cancer Treatment

EP: 16.Balancing Clinical and Economic Factors in Early Breast Cancer Treatment

EP: 17.Alternative Treatments for eBC and mBC

EP: 18.Navigating Therapy Approval for Early Breast Cancer: An Operational Perspective

EP: 19.Bridging the Gap: Multidisciplinary Collaboration in Early Breast Cancer Care

EP: 20.Key Takeaways on mBC and eBC

This is a synopsis of a Peer Exchange series featuring Aimee Keegan, PharmD, BCOP, of City of Hope.

In this video, Aimee Keegan, PharmD, BCOP, discusses the NATALEE trial, a phase 3 study that evaluated the use of adjuvant ribociclib in early breast cancer. The trial included patients at high risk of recurrence, including those with no nodal involvement, and assessed invasive disease-free survival at 3 years. The study found a significant difference in the ribociclib plus aromatase inhibitor (AI) arm compared to the hormonal therapy alone arm. Specifically, ribociclib led to a 30% risk reduction for stage 2 patients and a 24.5% risk reduction for stage 3 patients. However, overall survival data is still immature, and the results have not yet led to the approval or addition of ribociclib to the NCCN guidelines.

Dr. Keegan compares the NATALEE trial to the monarchE trial, which led to the approval of abemaciclib in the adjuvant setting and is currently included in the guidelines. The main difference between the two trials is that NATALEE allowed earlier stage patients, including those who were node-negative (T2N0), as long as they had a high risk of recurrence. In contrast, monarchE only included node-positive patients. This difference expands the patient population eligible for CDK4/6 inhibitors in the adjuvant setting to include high-risk, node-negative patients who would otherwise not qualify.

The potential approval of ribociclib based on the NATALEE trial results could provide patients with more options, particularly those who cannot tolerate abemaciclib. Dr. Keegan gives an example of a patient experiencing significant diarrhea with abemaciclib who would prefer to stop treatment. In such cases, having ribociclib approved would allow healthcare providers to switch to another agent and offer different options. This approval would expand patient access to CDK4/6 inhibitors in the adjuvant setting.

Dr. Keegan emphasizes that the NATALEE trial results could significantly impact the treatment landscape for early breast cancer patients at high risk of recurrence, providing them with additional treatment options and potentially improving outcomes. However, she also notes that further data, particularly on overall survival, is needed before ribociclib can be officially approved and added to clinical guidelines for use in the adjuvant setting.

*Video synopsis is AI-generated and reviewed by Pharmacy Times editorial staff.