A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib

Part of paid clinical trials in Sedona, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03050398
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ribociclib — DRUG
    ribociclib + letrozole
  • letrozole — DRUG
    ribociclib + letrozole

Study Details

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.

Key Dates

Start date
Jun 7, 2017
Status verified
May 2020
Primary completion
Mar 8, 2019
Completion
Mar 8, 2019

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: ribociclib + letrozole
    ribociclib with letrozole per the core study

Primary Outcome Measure

Identify Mutations of Genes From Tissue Samples Between Baseline and Time to Progression to Determine Modes of Resistance to Ribociclib After Disease Progression [ Time Frame: Baseline, time of progression approximately 24 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
Arizona Oncology Associates PC HALSedonaArizona86336-
Pacific Shores Medical Group SCLong BeachCalifornia90813-
Oncology Speciialists of CharlotteCharlotteNorth Carolina28207-
McLeod Center for Cancer Treatment and ResearchFlorenceSouth Carolina29506-
Carolina Blood and Cancer Care of South CarolinaRock HillSouth Carolina29732-
PeaceHealth St Joseph Medical CenterBellinghamWashington98225-

Find similar trials in Sedona, AZ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Arizona Oncology Associates PC HAL· Sedona, AZPacific Shores Medical Group SC· Long Beach, CAOncology Speciialists of Charlotte· Charlotte, NCMcLeod Center for Cancer Treatment and Research· Florence, SCCarolina Blood and Cancer Care of South Carolina· Rock Hill, SCPeaceHealth St Joseph Medical Center· Bellingham, WA

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