CompLEEment-1 Canadian Correlative Sub-Study

HR+ HER2 Breast Cancer Clinical Trial

— LEEomic  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03613220
• Other study ID #: CLEE011ACA02
• Status: Completed
• Phase: Phase 2
• Start date: December 28, 2018
• Est. completion date: January 6, 2020

Study information

• Verified date: March 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: January 6, 2020
• Est. primary completion date: January 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• HR+ HER2 Breast Cancer

Intervention

Drug:
• ribociclib
600 mg ribociclib oral once daily
• letrozole
letrozole 2.5 mg oral once daily

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Barrie	Ontario
Canada	Novartis Investigative Site	Calgary	Alberta
Canada	Novartis Investigative Site	Cambridge	Ontario
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	Greenfield Park	Quebec
Canada	Novartis Investigative Site	Kelowna	British Columbia
Canada	Novartis Investigative Site	Kingston	Ontario
Canada	Novartis Investigative Site	Kitchener	Ontario
Canada	Novartis Investigative Site	London	Ontario
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Ottawa	Ontario
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	Sault Ste Marie	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Vancouver	British Columbia
Canada	Novartis Investigative Site	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of proteomic biomarkers of response to ribociclib	Archival tumor biopsies derived from the study will be submitted for proteomic analysis to identify proteomic expression levels that may serve as predictor of response, stable disease, or progressive disease (cohort with a time to progression of 22 months or more)	Baseline up to approximately 30 months
Secondary	ctDNA levels to measure the degree of mutational burden [measured as copy number]	If available, blood samples taken at time of progression or end of treatment will be analyzed for ctDNA to measure the degree of mutational burden and to study if there is any correlation between degree of mutational burden and response or lack there of.	Baseline up to approximately 30 months