A Study of Lenvatinib, Pembrolizumab, and Fulvestrant in People With Breast Cancer
Trial Parameters
Brief 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 Criteria
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. * Progressed on at least 1 prior endocrine therapy combined with CDK 4/6 inhibitor. Prior fulvestrant therapy is permitted. * Have not received more than 2 lines of chemotherapy in the metastatic setting. * Stable previously treated brain metastases i.e. without radiological evidence of progression for at least 4 weeks (note that repeat imaging should be performed during study screening), clinically stable an