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

Triple Negative Breast Cancer Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

• NCT number: NCT04427293
• Study type: Interventional
• Source: University of Illinois at Chicago
• Contact: Oana Danciu, MD
• Phone: 312-996-1581
• Email: ocdanciu@uic.edu
• Status: Recruiting
• Phase: Phase 1
• Start date: July 9, 2020
• Completion date: July 2026