drugset / Trial / NCT05755048

FS-1502 Versus T-DM1 for HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

NCT05755048

RandomizedParallel-groupOpen-labelTreatment

Summary

This study is designed to compare the anti-tumor activity as well as the safety and efficacy of FS-1502 versus T-DM1 in HER2-positive, unresectable locally advanced or metastatic breast cancer subjects previously treated with trastuzumab and taxane.

Timeline

Start
2023-03-28
Primary completion
2025-07-30
Completion
2026-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject TRASTUZUMAB MAFODOTIN Monoclonal antibody 2.3 mg/kg Intravenous
Comparator Trastuzumab emtansine Other / unclassified 3.6 mg/kg Intravenous

Indications