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

NCT05286437 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • MSD Pharma (Singapore) Pte Ltd

    collaborator UNKNOWN

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

  • Dr. Yoon-Sim YAP · National Cancer Centre, Singapore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2026-12-31
Completion
2028-12-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05286437 on ClinicalTrials.gov