22CHA800: Genetically-Informed Therapy for ER+ Breast Cancer in a Post-CDK4/6 Inhibitor Setting: A Phase II Umbrella Study (GERTRUDE)
Principal Investigator
Study Number
STUDY02001800
Summary
This study is for patients who have advanced ER+, HER2- breast cancer and are currently or have previously received treatment with palbociclib, ribociclib, or abemaciclib. Participants will be assigned to one of four study groups based on their tumor genetic profile. They will receive either neratinib and fulvestrant, alpelisib and fulvestrant, everolimus and fulvestrant, or abemaciclib and fulvestrant. The combinations of fulvestrant/alpelisib and fulvestrant/abemaciclib are FDA-approved for this use. Fulvestrant, neratinib, and everolimus are each approved for the treatment of advanced breast cancer. The combinations of fulvestrant/neratinib and fulvestrant/everolimus have been tested in clinical trials for ER+/HER2- breast cancer but are not FDA-approved drug combinations. Researchers hope to learn if certain drug combinations are effective treatments for patients with advanced ER+/HER2- who have previously been treated with palbociclib, ribociclib, or abemaciclib.
Phase
II
Contact
Available at the following location(s)
- Lebanon
View more details at ClinicalTrials.gov
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