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Double-blind Randomised Phase I/IIb Study


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Metastatic Breast Cancer

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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

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