RecruitingPhase 2NCT05286437

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


Sponsor

National Cancer Centre, Singapore

Enrollment

40 participants

Start Date

Feb 15, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study tests the combination of lenvatinib (a targeted drug) and pembrolizumab (an immunotherapy) for women with hormone receptor-positive (ER+ or PR+) metastatic breast cancer that has stopped responding to hormone-blocking therapy. The study is open to women who carry a specific genetic variant called FGFR1 or FGF amplification. **You may be eligible if...** - You are 21 or older with metastatic or locally advanced breast cancer that is ER+ and/or PR+ (hormone receptor-positive) and HER2-negative - Your cancer has progressed despite at least 1 line of hormone therapy - You have not previously received lenvatinib - You have received at most 1 prior line of chemotherapy for advanced disease **You may NOT be eligible if...** - You have active brain metastases requiring treatment - You have significant cardiovascular disease or high blood pressure that is uncontrolled - You have active autoimmune disease or have had prior organ transplant - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOral 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.


Locations(1)

National Cancer Centre Singapore

Singapore, Singapore

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NCT05286437