drugset / Trial / NCT03262935

SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer

NCT03262935

Phase 3 Completed 437 enrolled Byondis B.V.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to demonstrate that SYD985 \[(vic-)trastuzumab duocarmazine\] is superior to physician's choice in prolonging progression free survival.

Timeline

Start
2017-12-15
Primary completion
2021-03-31
Completion
2022-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule
Comparator Eribulin Small molecule
Comparator Lapatinib Small molecule
Comparator Trastuzumab Monoclonal antibody
Subject Trastuzumab duocarmazine Other / unclassified Intravenous
Comparator Vinorelbine Small molecule

Indications