drugset / Trial / NCT07151586

Testing Two Different Drugs (Sacituzumab-govitecan and Trastuzumab-deruxtecan) Combinations Prescribed in an Alterning Pattern to Patients With Metastatic or Locally Advanced Triple-negative Breast Cancer

NCT07151586

Phase 2 Not yet recruiting 260 enrolled UNICANCER
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a phase II, multicentre, open-label, randomised controlled trial (patients are randomly assigned to one treatment arm or the other) evaluating two treatment strategies (sacituzumab govitecan and trastuzumab deruxtecan in an alternative schema or sacituzumab govitecan alone) in patients with locally advanced or metastatic triple-negative breast cancer. The goal is to answer the question: Does alternating sacituzumab goveitecan (SG) and trastuzumab deruxtecan (T-DXd) improve survival in patients with HER2-low metastatic triple-negative breast cancer compared to continuing treatment with SG alone?

Timeline

Start
2025-10
Primary completion
2029-10
Completion
2029-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Sacituzumab Govitecan Monoclonal antibody 10 mg/kg Intravenous
Subject Trastuzumab deruxtecan Monoclonal antibody 5.4 mg/kg Intravenous