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Hormone Therapy

Lenvatinib + Pembrolizumab + Fulvestrant for Breast Cancer

Phase 1 & 2
Led By Sherry Shen, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male participants or premenopausal females are eligible as long as they are on LHRH agonist for at least four weeks prior to starting trial therapy and commit to continue LHRH agonist for as long as patient is receiving trial therapy or medical contraindications arise
Patients diagnosed with ER+ (ER >1%), HER2- breast cancer as per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial tests a new drug combo to treat breast cancer with fewer side effects.

Who is the study for?
This trial is for adults with ER+/HER2- metastatic breast cancer who have stable brain metastases, not pregnant or breastfeeding, and have had no more than two chemotherapy treatments in the metastatic setting. They must agree to contraception if applicable and have adequate organ function. People can't join if they've used certain immune therapies, VEGF inhibitors like lenvatinib before, or had recent vaccines or other cancer treatments.Check my eligibility
What is being tested?
The study tests a combination of three drugs: Lenvatinib, Pembrolizumab, and Fulvestrant for safety and effectiveness in treating ER+/HER2- metastatic breast cancer. It aims to find out if this drug mix causes only mild side effects while being an effective treatment option.See study design
What are the potential side effects?
Possible side effects include high blood pressure controlled by medication; protein in urine; difficulty swallowing pills; active infections requiring antibiotics; gastrointestinal issues affecting drug absorption; significant bleeding or cardiovascular problems within the past year.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am a man or a woman who has not gone through menopause and have been on hormone therapy for at least 4 weeks.
My breast cancer is ER+ and HER2- according to ASCO/CAP guidelines.
I can provide a recent biopsy of my tumor, or have archival tissue if a new biopsy isn't possible.
My organs are functioning well, tested within the last 14 days.
I am a man and agree to follow specific rules during and 7 days after treatment.
My brain metastases have been stable for at least 4 weeks and I don't need steroids.
I am fully active or restricted in physically strenuous activity but can do light work.
I am not pregnant or breastfeeding.
I have had 2 or fewer chemotherapy treatments for my cancer after it spread.
My cancer progressed after treatment with hormone therapy and a CDK 4/6 inhibitor.
My cancer can be measured and has grown in previously treated areas.
I am 18 or older with advanced breast cancer that cannot be surgically removed.
My blood pressure is ≤150/90 mm Hg and stable on my current medications.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The number of adverse events and dose-limiting toxicities to find the Recommended Phase 2 Dose (RP2D)
Secondary outcome measures
Overall response rate (ORR)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lenvatinib, Pembrolizumab, and FulvestrantExperimental Treatment3 Interventions
This is an open-label phase Ib/II trial of lenvatinib (20mg orally PO daily) plus pembrolizumab (400mg IV Q6W) plus fulvestrant (500mg IM Q4W) in patients with unresectable, locally advanced/metastatic ER+/HER2- breast cancer.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 3
Completed Phase 4

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,577 Total Patients Enrolled
203 Trials studying Breast Cancer
81,137 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,528 Total Patients Enrolled
59 Trials studying Breast Cancer
7,534 Patients Enrolled for Breast Cancer
Sherry Shen, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How prevalent is the clinical trial in Canadian health care facilities?

"This research is taking place across 7 different sites, such as Memorial Sloan Kettering Monmouth (Limited Protocol Activities) in Middletown and Memorial Sloan Kettering Bergen (Limited Protocol Activities) in Montvale. Additionally, there are 4 other locations where this study is being conducted."

Answered by AI

Is this research endeavor currently enrolling participants?

"Clinicialtrials.gov reports that this particular trial is not presently attracting participants, with its posting and last update being on November 1st 2023 and October 31th 2023 respectively. However, there are currently 2426 other trials actively seeking volunteers to join their research programmes."

Answered by AI
~29 spots leftby Nov 2026