A Phase Ib/II Trial of Lenvatinib Plus Pembrolizumab Plus Fulvestrant in ER-positive/ HER2- Negative Metastatic Breast Cancer
Memorial Sloan Kettering Cancer Center
Summary
The purpose of this study is to test whether the combination of lenvatinib, pembrolizumab, and fulvestrant is a safe and effective treatment that causes few or mild side effects in people with ER+/HER2- metastatic breast cancer.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female participants who are ≥18 years old with histologically confirmed diagnosis of unresectable locally advanced or MBC. * Male participants or premenopausal females are eligible as long as they are on LHRH agonist for at least four weeks prior to starting trial therapy and commit to continue LHRH agonist for as long as patient is receiving trial therapy or medical contraindications arise * Patients diagnosed with ER+ (ER \>1%), HER2- breast cancer as per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. * Progresse…
Interventions
- DrugLenvatinib
20mg orally PO daily
- DrugPembrolizuma
400mg IV Q6W
- DrugFulvestrant
500mg IM Q4W
Locations (7)
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, New York