CompLEEment-1 Canadian Correlative Sub-Study

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

ClinicalTrials.gov Identifier: NCT03613220

Novartis Reference Number: CLEE011ACA02

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

Collection of tumor 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.

Condition

HR+ HER2 Breast Cancer

Phase

Phase 2

Overall status

Recruiting

Enrollment count

150 participants

Last update

May 19, 2020

Start date

Dec 28, 2018

Completion date

Dec 30, 2020

Gender

All

Age(s)

(Child, Adult, Older Adult)

Interventions

Drug

ribociclib

600 mg ribociclib oral once daily

Drug

letrozole

letrozole 2.5 mg oral once daily

Eligibility Criteria

Inclusion Criteria:

must have been eligible and participated in the main LEE011A2404 study
must provide consent to collect samples

Exclusion Criteria:

if consent not given to collect samples
Patients without either archival tumor tissue block or slides accessible