CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 500 enrolled
Drug / intervention
Trastuzumab +3 morebiological
Likely dose
Trastuzumab 8mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02472964
NCT02472964Phase 3Completed
CompareCT.gov

A Multicenter, Double-Blind, Randomized, Parallel-Group, Phase III Study of the Efficacy and Safety of Hercules Plus Taxane Versus Herceptin® Plus Taxane as First Line Therapy in Patients With HER2-Positive Metastatic Breast Cancer

Mylan Inc.·interventional·Posted Jun 16, 2015·Updated Feb 14, 2022

In Brief

A Phase 3 clinical trial evaluating Trastuzumab, MYL- 1401O, and 2 other interventions for Breast Cancer. Completed, enrolled 500 participants across 92 sites in 15 countries.

Detailed Summary

A multicenter, double-blind, randomized, parallel-group, Phase III study of the efficacy and safety of Hercules( Myl 1401O, Mylan Trastuzumab) plus taxane versus Herceptin® plus taxane as first line therapy in patients with HER2-positive metastatic breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesBrazil, Chile, Georgia, Hungary, India, Latvia, Peru, Romania, Russia, Serbia, Slovakia, South Africa, Thailand, Turkey (Türkiye), Ukraine
CollaboratorsMylan GmbH

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 16, 2015
Enrollment StartJul 1, 2012
Primary CompletionMar 1, 2016
Study CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 11.0 years ago

Interventions

Trastuzumabbiological

Trastuzumab 8mg/kg Iv over 90 minutes x 1 then Trastuzumab 6 mg/kg IV over 30 minutes every 3 weeks

MYL- 1401Obiological

MYL-1401O 8mg/kg Iv over 90 minutes x 1 then HERMyl 1401O Trastuzumab 6 mg/kg IV over 30 minutes every 3 weeks

Paclitaxeldrug

Paclitaxel 80mg/m2 IV over 60 minutes weekly.

Docetaxeldrug

Docetaxel 75mg/m2 IV over 60 minutes on day 1 of a 3 week cycle