Recruitment

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