drugset / Trial / NCT04494425

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

NCT04494425

Phase 3 Active not recruiting 866 enrolled AstraZeneca Daiichi Sankyo · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.

Timeline

Start
2020-07-24
Primary completion
2024-03-18
Completion
2026-06-19

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule Oral
Comparator Paclitaxel Small molecule Intravenous
Subject Trastuzumab deruxtecan Monoclonal antibody Intravenous

Indications