Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Best Overall Response Rate (BORR) (Calliper)

Outcome Description:

The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from calliper measurement). CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by Calliper: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome Time Frame:

24 weeks

Safety Issue:

No

Principal Investigator

Toshiyuki Kihara

Investigator Role:

Study Director

Investigator Affiliation:

Clinical

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

D539BC00001

NCT ID:

NCT00605267

Start Date:

October 2007

Completion Date:

December 2010

Related Keywords:

• Breast Cancer
• Breast Cancer
• Breast Neoplasms
• Tumors or cancer of the human BREAST
• Tumor or cancer of the human MAMMARY GLAND
• Breast Neoplasms