Study Stopped
GCP issues.
A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib
1 other identifier
interventional
8
1 country
6
Brief Summary
This study was a companion study to CLEE011A2404 which provided the opportunity for the collection of tumor tissue samples to better understand relevant mutations and the mechanisms responsible for resistance to treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 breast-cancer
Started Jun 2017
Shorter than P25 for phase_3 breast-cancer
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2017
CompletedFirst Posted
Study publicly available on registry
February 10, 2017
CompletedStudy Start
First participant enrolled
June 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2019
CompletedResults Posted
Study results publicly available
May 15, 2020
CompletedMay 28, 2020
May 1, 2020
1.8 years
February 6, 2017
March 6, 2020
May 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Identify Mutations of Genes From Tissue Samples Between Baseline and Time to Progression to Determine Modes of Resistance to Ribociclib After Disease Progression
Mutations of genes that were relevant to HR+ and the CDK4/6 pathway such as but not limited to CCND1, CDKN2A, PIK3CA and PTEN to identify the potential mechanisms of progression.
Baseline, time of progression approximately 24 months
Secondary Outcomes (1)
Compare the Differences in Mutations Across Various Races / Ethnicities Based on Baseline Samples
Baseline, time of progression approximately 24 months
Study Arms (1)
ribociclib + letrozole
EXPERIMENTALribociclib with letrozole per the core study
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent was to have been obtained prior to any baseline/screening procedures.
You may not qualify if:
- Patients without either fresh or archival tumor tissue accessible.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Arizona Oncology Associates PC HAL
Sedona, Arizona, 86336, United States
Pacific Shores Medical Group SC
Long Beach, California, 90813, United States
Oncology Speciialists of Charlotte
Charlotte, North Carolina, 28207, United States
McLeod Center for Cancer Treatment and Research
Florence, South Carolina, 29506, United States
Carolina Blood and Cancer Care of South Carolina
Rock Hill, South Carolina, 29732, United States
PeaceHealth St Joseph Medical Center
Bellingham, Washington, 98225, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2017
First Posted
February 10, 2017
Study Start
June 7, 2017
Primary Completion
March 8, 2019
Study Completion
March 8, 2019
Last Updated
May 28, 2020
Results First Posted
May 15, 2020
Record last verified: 2020-05