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)
Study of efficacy of ribociclib plus fulvestrant in patients with metastatic breast cancer
Sponsor: Novartis
Enrolling: Male and Female Patients
IRB Number: AAAP9506
U.S. Govt. ID: NCT02632045
Contact: Research Nurse Navigator: 212-342-5162 /
Additional Study Information: 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
Melissa Accordino, MD
Do You Qualify?
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
You may be eligible for this study

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