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Hormone Therapy

Lenvatinib + Pembrolizumab + Fulvestrant for Breast Cancer

Phase 1 & 2

Recruiting

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

Patients diagnosed with ER+ (ER >1%), HER2- breast cancer as per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines

Have not received more than 2 lines of chemotherapy in the metastatic setting

Timeline

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

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My breast cancer is ER+ and HER2- according to ASCO/CAP guidelines.

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I have had 2 or fewer chemotherapy treatments for my cancer after it spread.

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I am 18 or older with advanced breast cancer that cannot be surgically removed.

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My blood pressure is ≤150/90 mm Hg and stable on my current medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fulvestrant

2011

Completed Phase 3

~3690

Lenvatinib

2005

Completed Phase 4

~2690

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,855 Total Patients Enrolled

203 Trials studying Breast Cancer

81,103 Patients Enrolled for Breast Cancer

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,061,103 Total Patients Enrolled

59 Trials studying Breast Cancer

7,498 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

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study of Lenvatinib, Pembrolizumab, and Fulvestrant in People With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06110793.