Trial Information
Double-blind Randomised Phase I/IIb Study
Patients will receive CT-P6 or Herceptin.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
PK parameter
Outcome Time Frame:
months
Safety Issue:
No
Principal Investigator
Investigational Site
Investigator Role:
Principal Investigator
Investigator Affiliation:
Samsung Medical Center
Authority:
Korea: Food and Drug Administration
Study ID:
CT-P6/1.1
NCT ID:
NCT01084863
Start Date:
January 2010
Completion Date:
June 2013
Related Keywords:
- Metastatic Breast Cancer
- Herceptin
- Her 2-positive
- metastatic breast cancer
- CT-P6
- Breast Neoplasms