drugset / Trial / NCT02725541

Trial of Neoadjuvant Trastuzumab Emtansine in Patients With HER2-Equivocal Breast Cancer

NCT02725541

NaSingle-groupOpen-labelTreatment

Summary

This is an open label, neoadjuvant phase II study to evaluate the objective response, toxicity, and safety of trastuzumab emtansine in patients with newly diagnosed HER2-equivocal breast cancer. Trastuzumab emtansine at a dose of 3.6 mg/kg will be intravenously administered every 3 weeks for a total of 6 weeks. Patients who achieve a partial or complete response after the 6-week treatment (responders) will continue on trastuzumab emtansine for an additional 12 weeks.

Timeline

Start
2016-03
Primary completion
2019-04
Completion
2019-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Trastuzumab emtansine Other / unclassified 3.6 mg/kg Intravenous

Indications