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

Stopped early · Phase 3

Conditions studied: Breast Cancer

In brief

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 facts

Study ID

NCT03050398

Run by

Novartis Pharmaceuticals

People needed

8

Starts

2017-06-07

Expected to finish

2019-03-08

Last updated by the study team

2020-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent was to have been obtained prior to any baseline/screening procedures.
• Patients eligible for this companion sample collection protocol sample collection protocol must have met all inclusion in CLEE011A2404.

You may not qualify if…

• Patients eligible for this companion sample collection protocol must not have met any of the exclusion criteria in the CLEE011A2404 study, in addition to the following:
• Patients without either fresh or archival tumor tissue accessible.

Where it is running

• Arizona Oncology Associates PC HAL — Sedona, Arizona, United States
• Pacific Shores Medical Group SC — Long Beach, California, United States
• Oncology Speciialists of Charlotte — Charlotte, North Carolina, United States
• McLeod Center for Cancer Treatment and Research — Florence, South Carolina, United States
• Carolina Blood and Cancer Care of South Carolina — Rock Hill, South Carolina, United States
• PeaceHealth St Joseph Medical Center — Bellingham, Washington, United States

Full record on ClinicalTrials.gov

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