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

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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
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

Study Locations

Canada
Novartis Investigative Site
Recruiting
Calgary, T2N 4N2
Alberta
Canada
Novartis Investigative Site
Recruiting
Edmonton, T6G 1Z2
Alberta
Canada
Novartis Investigative Site
Recruiting
Kelowna, V1Y 5L3
British Columbia
Canada
Novartis Investigative Site
Recruiting
Vancouver, V5Z 4E6
British Columbia
Canada
Novartis Investigative Site
Recruiting
Winnipeg, R3E 0V9
Manitoba
Canada
Novartis Investigative Site
Recruiting
Barrie, L4M 6M2
Ontario
Canada
Novartis Investigative Site
Recruiting
Cambridge, N1R 3G2
Ontario
Canada
Novartis Investigative Site
Recruiting
Kingston, K7L 2V7
Ontario
Canada
Novartis Investigative Site
Recruiting
Kitchener, N2G 1G3
Ontario
Canada
Novartis Investigative Site
Recruiting
London, N6A 4L6
Ontario
Canada
Novartis Investigative Site
Recruiting
Ottawa, K1H 8L6
Ontario
Canada
Novartis Investigative Site
Recruiting
Sault Ste Marie, P6B 0A8
Ontario
Canada
Novartis Investigative Site
Recruiting
Toronto, M4N 3M5
Ontario
Canada
Novartis Investigative Site
Recruiting
Toronto, M5B 1W8
Ontario
Canada
Novartis Investigative Site
Recruiting
Greenfield Park, J4V 2H1
Quebec
Canada
Novartis Investigative Site
Recruiting
Montreal, H3T 1E2
Quebec
Canada
Novartis Investigative Site
Recruiting
Montreal, H3T 1M5
Quebec
Canada
Novartis Investigative Site
Recruiting
Quebec, G1S 4L8
-
Canada

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]