drugset / Trial / NCT04109391

Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03

NCT04109391

Phase 3 Completed 338 enrolled Tanvex BioPharma USA, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This is an extension study to provide adjuvant treatment with single agent Herceptin or TX05 and assess continued safety and immunogenicity in subjects with HER2-positive early breast cancer following neoadjuvant treatment and surgical resection in Protocol TX05-03.

Timeline

Start
2019-08-20
Primary completion
2021-12-25
Completion
2022-03-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Trastuzumab Monoclonal antibody 6 mg/kg Intravenous