drugset / Trial / NCT06841354

A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)

NCT06841354

Phase 3 Recruiting 1000 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.

Timeline

Start
2025-03-16
Primary completion
2030-05-18
Completion
2030-05-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule 2 unknown Intravenous
Comparator Gemcitabine Small molecule 1000 mg/m2 Intravenous
Comparator Paclitaxel Small molecule 80 mg/m2 Intravenous
Comparator Paclitaxel Small molecule 90 mg/m2 Intravenous
Comparator Paclitaxel Small molecule 100 mg/m2 Intravenous
Subject Pembrolizumab Monoclonal antibody 400 mg Intravenous
Subject Sacituzumab Tirumotecan Other / unclassified 4 mg/kg Intravenous