Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Objective Response

Outcome Description:

Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Objective tumor response was defined as a PR or CR.

Outcome Time Frame:

From day of first treatment through Week 25 or at time of discontinuation from study treatment.

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA180-088

NCT ID:

NCT00371345

Start Date:

December 2006

Completion Date:

May 2009

Related Keywords:

• Breast Cancer
• Metastasis
• Recurrent, locally-advanced, or metastatic breast cancer
• Breast Neoplasms
• Neoplasm Metastasis