drugset / Trial / NCT05950945

Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer

NCT05950945

Phase 3 Recruiting 250 enrolled Daiichi Sankyo AstraZeneca · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor \[HR\]-negative and HR-positive) unresectable and/or metastatic breast cancer.

Timeline

Start
2023-12-30
Primary completion
2027-10-01
Completion
2027-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Trastuzumab deruxtecan Monoclonal antibody 5.4 mg/kg Intravenous

Indications