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A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC
Sponsor: National Taiwan University Hospital
Summary
The 3 FDA-approved CDK4, 6 inhibitors, palbociclib, ribociclib, and abemciclib, all provided progression-free survival benefits when combined with endocrine therapy in advanced ER+/HER2- breast cancer. But, not all of them provided overall survival benefit in the same setting. One of the proposed mechanisms that influence the overall survival difference is from the different influence of the 3 CDK4, 6 inhibitors on tumor microenvironment and/ or immune system. However, there was no head-to-head comparison of the 3 CDK4, 6 inhibitors in the same study. Neoadjuvant therapy provides a window to obtain tissue samples before treatment, during treatment, and after treatment. We aim to compare the immune modulation effects of palbociclib, ribociclib, and abemaciclib with letrozole in neoadjuvant treatment for ER+/HER2- early breast cancer.
Official title: A Randomized, Open-label, Parallel-group Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in Early ER+/HER2- Breast Cancer
Key Details
Gender
FEMALE
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2022-09-16
Completion Date
2026-09-30
Last Updated
2023-03-16
Healthy Volunteers
No
Interventions
Palbociclib
CDK4, 6 inhibitor
Ribociclib
CDK4, 6 inhibitor
Abemaciclib
CDK4, 6 inhibitor
Letrozole
Endocrine therapy
Locations (2)
Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan
Department of Oncology,National Taiwan University Hospital
Taipei, Taiwan