Clinical Trial

Sac-TMT for Active TNBC Brain Metastases

Study acronym: BERLIN
Not Yet Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This is a multi-site prospective single-arm open-label phase 2 clinical trial including 20 participants with metastatic TNBC and active brain metastases to be treated with sacituzumab tirumotecan 4 mg/kg IV on Days 1, and 15 of every 28-day cycle until disease progression, unacceptable toxicities, consent withdrawal, or death.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2028-05 -> 2028-08 2026-07-25
minor Completion pushed: 2029-05 -> 2029-08 2026-07-25
Trial Details
NCT Number NCT07458113
Lead Sponsor Yale University
Collaborators: Johns Hopkins University, Merck Sharp & Dohme LLC, Translational Breast Cancer Research Consortium
Conditions Metastatic Triple Negative Breast Cancers
Enrollment 20 participants
Start Date 2026-08
Primary Completion 2028-08 (estimated)
Study Completion 2029-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-24