Actively Recruiting
Preoperative Lenvatinib Plus Pembrolizumab in Early-Stage Triple-Negative Breast Cancer (TNBC)
Led by University of Illinois at Chicago · Updated on 2025-12-16
12
Participants Needed
1
Research Sites
311 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is single arm study of a window of opportunity in which participants with previously untreated triple negative breast cancers (TNBC) who are candidates for potentially curative surgery will receive lenvatinib 12 mg daily for 7 and pembrolizumab 200 mg IV on day 1 prior to surgery
CONDITIONS
Official Title
Preoperative Lenvatinib Plus Pembrolizumab in Early-Stage Triple-Negative Breast Cancer (TNBC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older at time of consent
- Histologically confirmed invasive breast carcinoma (triple negative) by core or incisional biopsy
- Clinical stage T1b-T3/N0-N3/M0 suitable for curative surgery
- Availability of adequate diagnostic biopsy specimen for analysis
- Planned surgical removal of primary tumor and lymph node sampling after preoperative treatment
- Estrogen receptor and progesterone receptor negative, and HER2-negative breast cancer
- ECOG performance status of 0, 1, or 2 within 30 days prior to registration
- Adequate blood counts and organ function per defined laboratory criteria within 30 days prior
- No evidence of distant metastases (M0)
- Provided written informed consent and HIPAA authorization
- Women of childbearing potential must have a negative pregnancy test within 14 days before registration
- Women of childbearing potential must agree to use two effective forms of birth control during study and 120 days after last dose
- Ability to understand and comply with study procedures for entire study duration
You will not qualify if you...
- Active infection requiring systemic therapy
- Pregnant or breastfeeding
- Prior cancer treatment for current breast cancer including chemotherapy, immunotherapy, biologic therapy, or radiotherapy
- Previous lenvatinib or immune checkpoint inhibitor treatment within past 2 years
- Use of investigational drugs within 14 days or 5 half-lives prior to registration
- Major surgery within 14 days prior to registration or incomplete recovery from such surgery
- Prior or concurrent malignancy that may interfere with study safety or efficacy
- History of AIDS unless virologically suppressed on therapy with adequate CD4 count
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days
- History of stroke or transient ischemic attack within 6 months
- History of recent acute coronary syndrome or symptomatic pericarditis within 6 months
- Symptomatic heart failure or significant heart dysfunction
- Clinically significant cardiac arrhythmias or high-grade AV block without pacemaker
- Any severe or uncontrolled medical condition posing safety risk or protocol non-compliance
- Any condition jeopardizing patient safety or study compliance
- Mental or medical condition preventing informed consent or participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
O
Oana Danciu, MD
CONTACT
P
Prathmika Jha, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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