CompLEEment-1 Canadian Correlative Sub-Study

Official Title

LEEOMIC: CompLEEment-1 Canadian Correlative Sub-Study Comprehensive Proteomic Analysis Towards Discovery of Predictive Patterns of Protein Expression to Ribociclib Sensitivity and Resistance

Summary:

Collection of tumour and blood samples from subjects enrolled in the main study (LEE011A2404) will undergo proteomic and ctDNA analysis respectively to better understand mechanisms of response and resistance to ribociclib in combination with letrozole therapy.

Trial Description

Primary Outcome:

• Identification of proteomic biomarkers of response to ribociclib

Secondary Outcome:

• ctDNA levels to measure the degree of mutational burden [measured as copy number]

This is a sub-study of a phase IIIb interventional study (LEE011A2404). It cannot stand alone without the parent study.

View this trial on ClinicalTrials.gov