Preoperative Lenvatinib Plus Pembrolizumab in Early-Stage Triple-Negative Breast Cancer (TNBC)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Triple -Negative Breast Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
This is a single arm, window of opportunity study in which participants with previously untreated triple negative breast cancers (TNBC) who are candidates for potentially curative surgery will receive one 21-day cycle of therapy prior to surgery, consisting of lenvatinib 12 mg daily, days 1 through ...
This is a single arm, window of opportunity study in which participants with previously untreated triple negative breast cancers (TNBC) who are candidates for potentially curative surgery will receive one 21-day cycle of therapy prior to surgery, consisting of lenvatinib 12 mg daily, days 1 through 14, and pembrolizumab 200 mg IV on day 1. Participants will undergo surgical resection of the primary breast tumor 7-10 days after the last dose of lenvatinib. Post-operative adjuvant therapies will be at the discretion of the treating oncologist. Post-Surgery Follow-Up information will be collected at assessments at 3 months post-op and after that every 6 months until 5 years after surgery
Tracking Information
- NCT #
- NCT04427293
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Oana Danciu, MD University of Illinois at Chicago