Drug intelligence / Profile preview

chemotherapy + endocrine therapy + ribociclib

Development stage
Unknown
Lead developer
Novartis
Modality
Small Molecules
Administration
Oral, Intravenous
01

Overview

This combination treatment regimen, consisting of adjuvant chemotherapy followed by endocrine therapy and the CDK4/6 inhibitor ribociclib, is being evaluated in the Phase III NoLEEta clinical trial. Coordinated by UNICANCER in collaboration with Novartis, the trial investigates whether patients with intermediate-risk hormone receptor-positive, HER2-negative (HR+/HER2-) early breast cancer can maintain similar survival outcomes while potentially omitting the chemotherapy component. Ribociclib is a small molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6), which are critical regulators of the cell cycle; its inhibition prevents the phosphorylation of the retinoblastoma protein, leading to G1 phase arrest. Endocrine therapy (typically aromatase inhibitors like letrozole or anastrozole) targets the estrogen receptor signaling pathway to inhibit tumor growth, while chemotherapy provides broad cytotoxic effects against rapidly dividing cells.

Other names
NoLEEta trial regimenRibociclib plus endocrine therapy plus chemotherapy
02

Targets

CDK6 (Cyclin-dependent kinase 6)CDK4 (Cyclin-dependent kinase 4)ER (Estrogen receptor)

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