drugset

drugset / Trial / NCT01919229

A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1)

NCT01919229 ↗

Phase 2 Terminated 14 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupOpen-label

Summary

This is a multi-center, open-label Phase II randomized pre-surgical pharmacodynamics study.

Timeline

Start: 2013-10
Primary completion: 2014-09
Completion: 2014-09

Publications

Curigliano G, Gomez Pardo P, Meric-Bernstam F, Conte P, Lolkema MP, Beck JT, Bardia A, Martinez Garcia M, Penault-Llorca F, Dhuria S, Tang Z, Solovieff N, Miller M, Di Tomaso E, Hurvitz SA. Ribociclib plus letrozole in early breast cancer: A presurgical, window-of-opportunity study. Breast. 2016 Aug;28:191-8. doi: 10.1016/j.breast.2016.06.008. Epub 2016 Jun 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Letrozole	Other / unclassified	2.5 mg	Oral
Subject	Ribociclib	Small molecule	400 mg	Oral
Subject	Ribociclib	Small molecule	600 mg	Oral

Indications