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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

Must not have

Has an inability to swallow capsules

Has had an allogenic tissue/solid organ transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot swallow pills.

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I have received an organ or tissue transplant from another person.

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My heart's pumping ability is below normal.

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I have not had major surgery in the last 3 weeks.

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I have previously been treated with lenvatinib or similar drugs.

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I have been treated with specific immune therapy drugs before.

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I have a serious blood vessel condition.

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I have or had lung inflammation that needed steroids.

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My scans show my tumor is affecting major blood vessels or has hollow areas.

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I have active brain metastases or cancer in the lining of my brain.

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I have been treated for an autoimmune disease in the last 2 years.

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I have been diagnosed with HIV.

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I have an immune system disorder or am on long-term steroids.

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I have a severe fistula.

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I am currently taking antibiotics for an infection.

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I have a condition that affects how my body absorbs medication.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The number of adverse events and dose-limiting toxicities to find the Recommended Phase 2 Dose (RP2D)

Secondary study objectives

Overall response rate (ORR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3510

Lenvatinib

2017

Completed Phase 4

~2070