Trial | NCT01084863  Report issue

Title

Evaluate Safety, Efficacy and Pharmacokinetics
Double-blind Randomised Phase I/IIb Study

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    174
The purpose of the study is to demonstrate equivalent pharmacokinetics (PK)
Patients will receive CT-P6 or Herceptin.
Study Started
Feb 28
2010
Primary Completion
Dec 31
2011
Study Completion
Dec 31
2020
Anticipated
Last Update
Aug 09
2019

Drug CT-P6

CT-P6: administered every 3 weeks

Drug Herceptin

Herceptin: administered every 3 weeks

  • Other names: Trastuzumab

Drug Paclitaxel

Paclitaxel: administered every 3 weeks

CT-P6 & Paclitaxel Active Comparator

CT-P6 + Paclitaxel

Herceptin & Paclitaxel Active Comparator

Trastuzumab + Paclitaxel

Criteria 

Inclusion Criteria:

Are females
Have a Her 2 over-expression
Have ECOG 0 or 1

Exclusion Criteria:

Current clinical or radiographic evidence CNS metastases
Current Known infection
Pregnant or nursing mother
No Results Posted