NCT04427293

Preoperative Lenvatinib Plus Pembrolizumab in Early-Stage Triple-Negative Breast Cancer (TNBC)

BRE-03: Window of Opportunity Trial of Preoperative Lenvatinib Plus Pembrolizumab in Early-Stage Triple-Negative Breast Cancer (TNBC)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a single arm study of a window of opportunity study in which participants with previously untreated triple negative breast cancers (TNBC) who are candidates for potentially curative surgery will receive therapy prior to surgery, consisting of lenvatinib 12 mg daily for 7 days and pembrolizumab 200 mg IV on day 1. Subjects will either have curative surgery 7-10 days after last dose of lenvatinib, and post-operative adjuvant therapy as per institution guidelines or have a research core biopsy of the breast tumor 7-10 days after last dose of lenvatinib, and standard of care neoadjuvant chemotherapy +/\_ immune checkpoint inhibitor therapy, then curative surgery, post-operative adjuvant therapy as per institution guidelines

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Lenvatinib	Lenvatinib 12mg daily for 7 days prior to surgery
DRUG	Pembrolizumab	Pembrolizumab 200 mg IV on day 1

Timeline

• Start date: 2020-07-09
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2020-06-11
• Last updated: 2025-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study