CLEE011XUS18T: A randoMized phAse II trIal of fulvestraNt wiTh or without Ribociclib After progression on AntI-estrogeN therapy plus cyclin-dependent kinase 4/6 inhibition in patients with unresectable or metastatic hormone receptor positive, HER2 negative breast cancer (MAINTAIN Trial)
Sponsor: |
Novartis |
Enrolling: |
Male and Female Patients |
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 beyondprogression 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. Ribociclib and palbociclib (another CDK 4/6 inhibitor) are approved by the FDA to treat patients like you who have metastatic or unresectable breast cancer that is sensitive to hormones and which is not sensitive to the effects of the HER2 protein.
This study is closed
Investigator
Melissa Accordino, MD
Have you been diagnosed with adenocarcinoma of the breast? |
Yes |
No |
Are you free from congestive heart failure or other serious cardiac disease? |
Yes |
No |
If female, are you postmenopausal or receiving ovarian suppression? If male, please mark "yes." |
Yes |
No |