Overview

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

Status:
Terminated
Trial end date:
2019-03-08
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Letrozole
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.