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

Status:	Active, not recruiting
Conditions:	Breast Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	1/27/2019
Start Date:	June 7, 2017
End Date:	May 14, 2021

This study will allow for the collection of tumor tissue samples to better understand
relevant mutations and the mechanisms responsible for resistance to treatment.

This protocol is a sub-protocol of an interventional study. Because the main study is
interventional, this study was approved by FDA as an interventional study. It cannot stand
alone without the parent study. The sites will receive diagnostic information for all
patients that come on study.

Inclusion Criteria:

- Written informed consent must be obtained prior to any baseline/screening procedures.

- Patients eligible for this companion sample collection protocol sample collection
protocol must meet all inclusion in CLEE011A2404.

Exclusion Criteria:

- Patients eligible for this companion sample collection protocol must not meet any of
the exclusion criteria in the CLEE011A2404 study, in addition to the following:

- Patients without either fresh or archival tumor tissue accessible.

We found this trial at

sites

Carolina Blood and Cancer Care of South Carolina

1583 Health Care Drive
Rock Hill, South Carolina 29732

from

Rock Hill, SC