A Phase II Study Of Sunitinib Malate Single Agent For The Treatment Of Women With Advanced Breast Cancer

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants With Objective Response

Outcome Description:

Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions. PR defined as a greater than or equal to 30 percent (≥30%) decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Outcome Time Frame:

Baseline, Week 9, and every 8 weeks up to Month 34

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A6181068

NCT ID:

NCT00471276

Start Date:

August 2007

Completion Date:

June 2010

Related Keywords:

• Breast Neoplasms
• Metastatic Breast Cancer
• Breast Neoplasms
• Neoplasms