Preoperative Lenvatinib Plus Pembrolizumab for Early-Stage Triple-Negative Breast Cancer
This study is testing a new approach for women with early-stage triple-negative breast cancer (TNBC) who are planning to have surgery. You would receive two medications, Lenvatinib and Pembrolizumab, before your surgery. Lenvatinib is given daily for 7 days, and Pembrolizumab is given once through an IV. Researchers want to see if this combination therapy increases the number of certain immune cells (CD8+ tumor infiltrating lymphocytes, or TILs) in the tumor. This study is for women aged 18 and older with specific stages of TNBC. The study aims to enroll 12 participants, but its current recruitment status is unclear.
- Study design
- This is a single-arm study, meaning all participants receive the same treatment. It plans to enroll 12 participants.
- What's involved
- You would receive Lenvatinib daily for 7 days and Pembrolizumab once before surgery. You would then have surgery 7-10 days after the last dose of Lenvatinib, or a research biopsy followed by standard treatment and then surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will evaluate the effectiveness of the treatment by measuring immune cells in your tumor at 2 years.
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NCT04427293
Preoperative Lenvatinib Plus Pembrolizumab in Early-Stage Triple-Negative Breast Cancer (TNBC)
Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatmentUniversity of Illinois at ChicagoInvestigator-initiated
~12 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:LenvatinibPembrolizumab
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over 2 years
Conditions
Where it's being run
1 sites across 1 statesIllinois1
Study leadership
- Oana Danciu, MD · PRINCIPAL_INVESTIGATOR · University of Illinois at Chicago
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Less than or equal to 10% of tumor cells staining for ER and for PR by immunohistochemistry (IHC)
HER2-negative, as defined by ASCO/CAP guidelines55 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 30 days prior to study registration 8. Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 30 days prior to registration Hematological Leukocytes ≥2,500/mm3 Platelet count ≥ 100,000/mm3 Absolute Neutrophil Count (ANC) ≥ 1,500/mm3 Hemoglobin (Hgb) ≥ 9.0 g/dL Renal Creatinine/Calculated creatinine clearance (CrCl) Cr \< 1.5 x upper limit of normal (ULN) or CrCl ≥ 50 mL/min using the Cockcroft-Gault formula Hepatic Bilirubin Bilirubin ≤ 1.5 × ULN. Subjects with Gilbert's syndrome may have a bilirubin \> 1.5 × ULN, if no evidence of biliary obstruction exists Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN 9. No evidence of distant metastases (M0 as per AJCC staging guidelines) 10. Provided written informed consent and HIPAA authorization for release of personal health information, approved by an Institutional Review Board (IRB) 11. NOTE: HIPAA authorization may be included in the informed consent or obtained separately 12. Women of childbearing potential (WOCP) must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required within 14 days of study registration. If the urine test cannot be confirmed as negative, a serum pregnancy test will be required 13. Women of childbearing potential (WOCP) must be willing to use two effective methods of birth control such as an oral, implantable, injectable, or transdermal hormonal contraceptive, an intrauterine device (IUD), use of a double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream), or total abstinence for the course of the study until 120 days after the last dose of study drug NOTE: Women are considered to be of childbearing potential unless they are postmenopausal (≥45 years of age and has not had menses for greater than 12 consecutive months or bilateral oophorectomy) or surgically sterile (bilateral tubal ligation or hysterectomy) or not heterosexually active for the duration of the study and at least 120 days after the last dose of study drug 14. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study
Exclusion
History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 28 days prior to registration
History of cerebrovascular accident (CVA) or transient ischemic attack within 6 months prior to registration
History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 6 months prior to registration
Symptomatic congestive heart failure (New York Heart Association III-IV) or documented current left ventricular (LV) systolic dysfunction with left ventricular ejection fraction (LVEF) \<50% on most recent assessment of LV function
Clinically significant cardiac ventricular arrhythmias (e.g. sustained ventricular tachycardia/ventricular fibrillation) or high-grade AV block (e.g. bifascicular block, Mobitz type II and third-degree AV block) unless a pacemaker is in place
Any concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate subject participation in the clinical study or compromise compliance with the protocol 10. Any condition that, in the opinion of the investigator, might jeopardize the safety of the patient or interfere with protocol compliance 11. Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
What this trial 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 patients2 years
Measuring the presence of a T-cell inflamed TME, characterized by infiltration of CD8+ TILs