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Study of Efficacy and Safety of Myl1401O + Taxane vs Herceptin©+ Taxane for 1st Line, Met. Br. Ca.

NCT02472964 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2022-02-14

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Trastuzumab

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

BIOLOGICAL

MYL- 1401O

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

DRUG

Paclitaxel

Paclitaxel 80mg/m2 IV over 60 minutes weekly.

DRUG

Docetaxel

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

Sponsors & Collaborators

  • Mylan GmbH

    collaborator INDUSTRY

  • Mylan Inc.

    lead INDUSTRY

Principal Investigators

  • Eduardo Pennella, MD · Mylan Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2016-03-31
Completion
2018-08-31

Countries

  • Brazil
  • Chile
  • Georgia
  • Hungary
  • India
  • Latvia
  • Peru
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • Thailand
  • Turkey (Türkiye)
  • Ukraine

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02472964 on ClinicalTrials.gov