CLEE011XUS18T: Phase II randomized trial of fulvestrant with or without Ribociclib/LEE011 after progression on aromatase inhibition plus cyclin-dependent kinase 4/6 inhibition in patients with hormone receptor positive, HER2 negative breast cancer
Sponsor: |
Novartis |
Enrolling: |
Female Patients Only |
IRB Number: |
AAAP9506 |
U.S. Govt. ID: |
NCT02632045 |
Contact: |
Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
The purpose of this study is to determine whether there is clinical benefit to continue therapy beyond progression for metastatic or unresectable breast cancer. The treatment that is being investigated in this clinical trial, ribociclib (LEE011), is part of a family of oral medications (pills) that are called Cyclin Dependent Kinase 4 and 6 inhibitors, which are also referred to as CDK4/6 inhibitors for short. This family of medications targets the mechanism that drives the multiplication of cancer cells, and thus slows down the growth of tumors.
This study is closed
Investigator
Kevin Kalinsky, MD, MS
Have you been diagnosed with HER2 negative breast cancer? |
Yes |
No |