Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Time to Progression (TTP) - Expert Evaluation Committee Assessment

Outcome Description:

Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the expert evaluation committee using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).

Outcome Time Frame:

Up to 2008 days of the treatment

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

A5991048

NCT ID:

NCT00143390

Start Date:

April 2005

Completion Date:

December 2010

Related Keywords:

• Breast Neoplasms
• Breast Neoplasms
• Neoplasms