RecruitingPhase 1Phase 2NCT06110793

A Study of Lenvatinib, Pembrolizumab, and Fulvestrant in People With Breast Cancer

A Phase Ib/II Trial of Lenvatinib Plus Pembrolizumab Plus Fulvestrant in ER-positive/ HER2- Negative Metastatic Breast Cancer


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

49 participants

Start Date

Dec 29, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a three-drug combination — lenvatinib (a targeted therapy), pembrolizumab (an immunotherapy), and fulvestrant (a hormone-blocking drug) — in patients with advanced hormone-receptor-positive, HER2-negative breast cancer that has progressed after standard hormone therapy and CDK4/6 inhibitor treatment. **You may be eligible if...** - You are 18 or older with confirmed ER-positive, HER2-negative locally advanced or metastatic breast cancer - Your cancer progressed after at least one prior hormone therapy combined with a CDK4/6 inhibitor - You have measurable disease on scans - Your ECOG performance status is 0 or 1 - Your organ function (blood, liver, kidney, heart) is within acceptable range **You may NOT be eligible if...** - You have received prior pembrolizumab, lenvatinib, or other PD-1/PD-L1 or VEGF-targeting drugs - You have active, untreated cancer spread to the brain - You have an active autoimmune disease requiring systemic treatment - You have active HIV, untreated hepatitis B or C - You are unable to swallow capsules - 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

DRUGLenvatinib

20mg orally PO daily

DRUGPembrolizuma

400mg IV Q6W

DRUGFulvestrant

500mg IM Q4W


Locations(7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06110793


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