NCT05286437

Phase II Lenvatinib and Pembrolizumab in Endocrine Resistant Breast Cancer With Letrozole

Lenvatinib and Pembrolizumab in Endocrine Resistant Breast Cancer With Letrozole in the Advanced Setting - a Phase II Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II study testing the combination of Pembrolizumab with Lenvatinib, a multi-kinase inhibitor that has activity against vascular endothelial growth factor receptors 1-3 (VEGFR1-3), fibroblast growth factor receptors 1-4 (FGFR1-4), ret protooncogene (RET), platelet-derived growth factor receptor-alpha (PDGFR-alpha) and KIT (a stem cell factor receptor), and letrozole, a non-steroidal aromatase inhibitor, in advanced hormone receptor (HR) positive human epidermal growth factor receptor 2 (HER2) negative breast cancer (BC) that has progressed on/after standard endocrine therapy.

Conditions

• Hormone Receptor-Positive HER2-Negative Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Oral Lenvatinib + Intravenous (IV) Pembrolizumab + Oral Letrozole	Lenvatinib and Letrozole will be given orally (PO) daily from Day -14, while Pembrolizumab will be administered intravenously during week 1 of each 6-weekly cycle from Cycle 1 Day 1 (C1D1), with daily Lenvatinib and Letrozole.

Timeline

• Start date: 2023-02-15
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2022-03-18
• Last updated: 2026-04-06

Locations

1 site across 1 country: Singapore