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 negati

Protocol: 
AAAP9506
Phase: 
II

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 negati

To evaluate the progression-free survival (PFS) of fulvestrant with or without ribociclib after progression on an aromatase inhibitor plus cyclin-dependent kinase 4/6 inhibitor in patients with hormone receptor positive (HR+), HER2- breast cancer.

Are you Eligible? (Inclusion Criteria)

To be eligible for this trial, patients must be
- men or women at least 18 years of age with with metastatic or unresectable
breast cancer
- have postmenopausal status or receiving ovarian suppression, including
GnRH agonists (such as goserelin).
- no evidence of clinically significant congestive heart failure or other
serious cardiac disease and have adequate renal (kidney), liver, and bone
marrow function.

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States