Trial intelligence / Profile preview

Lenvatinib, Pembrolizumab, and Letrozole in Advanced Breast Cancer

NCT05286437Phase 2

Key facts

Status: Active, not recruiting
Start: Feb 2023
Primary completion: Dec 2026
Countries: 1
Sponsor: National Cancer Centre Singapore
Modality: Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes, Small Molecules

Drugs: lenvatinibpembrolizumab
Conditions: breast cancer

Overview

Phase 2, open-label, single-arm trial of lenvatinib and pembrolizumab in breast cancer, sponsored by National Cancer Centre Singapore. Primary endpoint: Objective Response Rate up to 2 years. Started Feb 2023; status: active, not recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Intervention
Oral Lenvatinib + Intravenous (IV) Pembrolizumab + Oral Letrozole

Who it enrols

Adults with ER/PgR positive, HER2-negative advanced breast cancer who progressed after at least 1 line of palliative endocrine therapy. Max 1 line of palliative chemotherapy allowed. Prior targeted therapy allowed except Lenvatinib. Prior anti-PD-1/L1/L2 excluded.

Endpoints

Primary

Objective Response RateUp to 2 years

Secondary

Progression-Free SurvivalUp to 3 years after End of Treatment
Progression-Free Survival per iRECISTUp to 3 years after End of Treatment
Objective Response Rate per iRECISTUp to 2 years
Duration of ResponseUp to 3 years after End of Treatment
Clinical Benefit RateUp to 3 years after End of Treatment
Overall SurvivalUp to 3 years after End of Treatment

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