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Tyrosine Kinase Inhibitor

Lenvatinib + Pembrolizumab for Breast Cancer

Phase 1
Recruiting
Led By Oana Danciu, MD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be candidates for curative surgical resection
Histologically confirmed invasive breast carcinoma documented by core needle biopsy or incisional biopsy (excisional biopsy is not allowed). AJCC 8th edition clinical stage T1b-T3/N0-N3/M0 by physical exam or radiologic studies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that could be curative for people with triple negative breast cancer.

Who is the study for?
This trial is for adults with early-stage triple-negative breast cancer (TNBC) who haven't had previous cancer treatments and are planning surgery. They must have good performance status, no distant metastases, adequate organ function, and not be pregnant or breastfeeding. Participants should agree to use effective birth control and be able to follow study procedures.Check my eligibility
What is being tested?
The trial tests Lenvatinib taken daily for a week plus one dose of Pembrolizumab given intravenously before surgery. It's designed to see if this combination can benefit patients with TNBC when administered preoperatively in those awaiting surgical tumor removal.See study design
What are the potential side effects?
Lenvatinib may cause high blood pressure, fatigue, diarrhea, decreased appetite, weight loss, nausea, inflammation of mucous membranes and proteinuria. Pembrolizumab could lead to immune-related side effects like inflammation in various organs including the lungs or intestines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am eligible for surgery aimed at curing my condition.
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My breast cancer was confirmed by a biopsy and is at a certain stage according to specific criteria.
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My cancer has not spread to distant parts of my body.
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I can understand and follow the study's procedures for its duration.
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I can care for myself and am up and about more than 50% of my waking hours.
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I am planning to have surgery to remove my breast tumor and check the nearby lymph nodes after chemotherapy.
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My breast cancer is triple-negative.
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I have a biopsy sample available for analysis.
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My recent tests show my organs are functioning well.
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I am using two effective birth control methods or practicing total abstinence as a woman able to have children.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate the effectiveness of preoperative anti-vascular endothelial growth factor receptor (VEGFR) therapy and immune checkpoint blockade on infiltration of CD8+ tumor infiltrating lymphocytes (TILs) (CD45RA-/CD8+/FoxP3-) in primary tumors from patients
Secondary outcome measures
Evaluate clinical response to preoperative anti-VEGFR therapy and immune checkpoint blockade based on pathologic complete response and residual tumor burden in subjects receiving neoadjuvant chemotherapy and changes in the Ki-67 index in all patients.
Evaluate treatment tolerability of preoperative anti-VEGFR therapy and immune checkpoint blockade assessed by failure to completed planned course of neoadjuvant chemo-immune therapy and surgery in patients with early-stage TNBC
Other outcome measures
Evaluate quality of life in patients with early-stage TNBC treated with preoperative anti-VEGFR therapy and immune checkpoint blockade

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment2 Interventions
All participants will receive lenvatinib 12mg daily for 7 days and pembrolizumab 200 mg IV on day 1 prior to surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
2005
Completed Phase 4
~2690
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
604 Previous Clinical Trials
1,558,983 Total Patients Enrolled
11 Trials studying Breast Cancer
1,342,356 Patients Enrolled for Breast Cancer
Oana Danciu, MDPrincipal Investigator - University of Illinois at Chicago
University of Illinois Medical Center at Chicago, University of Illinois at Chicago Eye & Ear Infirmary
University De Medical Si Farm (Medical School)
1 Previous Clinical Trials
200 Total Patients Enrolled

Media Library

Lenvatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04427293 — Phase 1
Breast Cancer Research Study Groups: Open Label
Breast Cancer Clinical Trial 2023: Lenvatinib Highlights & Side Effects. Trial Name: NCT04427293 — Phase 1
Lenvatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04427293 — Phase 1

Frequently Asked Questions

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

What is the upper threshold of participants for this research endeavor?

"Affirmative, the information on clinicaltrials.gov reveals that this medical trial is still recruiting subjects. It was first published on July 9th 2020 and last modified on June 22nd 2022. The study needs to enrol 12 people between a single research site."

Answered by AI

What medical maladies has Pembrolizumab been effective in addressing?

"Pembrolizumab is an immunotherapy agent primarily employed to battle malignant neoplasms. It can also be utilized in the treatment of obscure melanoma, microsatellite instability high disorders, and post-chemotherapy disease progression."

Answered by AI

What other research has been undertaken in relation to the efficacy of Pembrolizumab?

"Currently, 1034 studies are researching the effects of Pembrolizumab with 134 of them being in phase 3. Sacramento, California is home to a number clinical trials on this topic; however there exist 37106 other locations conducting research related to it as well."

Answered by AI

Are there current vacancies for participants in this clinical experiment?

"Affirmative. According to information hosted on clinicaltrials.gov, the trial that was initially advertised on July 9th 2020 is presently recruiting participants with 12 patients needed across 1 centre."

Answered by AI

To what extent does Pembrolizumab pose a risk to individuals?

"Our risk assessment at Power gave Pembrolizumab a score of 1 due to limited clinical evidence on both its safety and effectiveness, as this is only the first stage in drug trials."

Answered by AI
~5 spots leftby Jul 2026