Clinical Trial: NCT05766410
A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC
Status:
UNKNOWNPhase:
Phase 2| Lead Sponsor: | National Taiwan University Hospital |
| Information Provided By: | National Taiwan University Hospital |
| Last Update Posted: | 2023-03-16 |
Study Overview
Brief 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
Conditions
Intervention / Treatment
- Drug: Palbociclib
- Drug: Ribociclib
- Drug: Abemaciclib
- Drug: Letrozole
Other Study ID Numbers
- 202207200MIPB
Start Date (Actual)
Primary Completion Date (Estimated)
Study Completion Date (Estimated)
Enrollment (Estimated)
Study Type
Phase
| Lead Sponsor: | National Taiwan University Hospital |
| Information Provided By: | National Taiwan University Hospital |
| Last Update Posted: | 2023-03-16 |
Study Overview
Brief 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
Conditions
Intervention / Treatment
- Drug: Palbociclib
- Drug: Ribociclib
- Drug: Abemaciclib
- Drug: Letrozole
Other Study ID Numbers
- 202207200MIPB