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CompLEEment-1 Canadian Correlative Sub-Study (LEEomic)

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ClinicalTrials.gov Identifier: NCT03613220
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
HR+ HER2 Breast Cancer Drug: ribociclib Drug: letrozole Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: This sub-protocol allows for the collection of tumor and blood samples for proteomic and ctDNA analysis respectively to better understand mechanisms of response and resistance to ribociclib therapy.
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : December 28, 2018
Estimated Primary Completion Date : December 28, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ribociclib + letrozole
Ribociclib oral (3 weeks on/1 week off) in combination with oral once daily letrozole: 600 mg ribociclib QD + 2.5 mg letrozole QD
Drug: ribociclib
600 mg ribociclib oral once daily

Drug: letrozole
letrozole 2.5 mg oral once daily




Primary Outcome Measures :
  1. Identification of proteomic biomarkers of response to ribociclib [ Time Frame: Baseline up to approximately 30 months ]
    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)


Secondary Outcome Measures :
  1. ctDNA levels to measure the degree of mutational burden [measured as copy number] [ Time Frame: Baseline up to approximately 30 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03613220


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 sina.haftchenary@Novartis.com
Contact: Novartis Pharmaceuticals

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

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03613220     History of Changes
Other Study ID Numbers: CLEE011ACA02
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
advanced HR+ HER2 breast cancer
breast cancer
proteomic analysis
protein expression
ctDNA Analysis
adult
LEE011
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs