Study of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ HER2- Advanced Breast Cancer
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
This is a randomized trial for patients with metastatic hormone receptor (HR)-positive human
epidermal growth factor receptor 2 (HER2)-negative breast cancer who have progressed on an
aromatase inhibitor plus a CDK4/6 inhibitor (either palbociclib or ribociclib) to either
fulvestrant alone or fulvestrant with ribociclib (LEE-011). The purpose of the trial is to
determine whether there is continued benefit for patients to remain on a CDK4/6 inhibitor at
the time of switching anti-estrogen therapy. As ribociclib and palbociclib have a similar
toxicity and drug profile and mechanism of action, we feel that it is appropriate for
patients to receive either drug with an aromatase inhibitor prior to randomization.