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

Phase 2
18 Years
Not Enrolling
Breast Neoplasms

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Trial Information

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

Inclusion Criteria:

- Histologically or cytologically proven diagnosis of breast cancer

- Metastatic or locally recurrent disease that is, in the opinion of the investigator,
not amenable to resection or radiation therapy

- Patients with at least one measurable lesion as per RECIST

Exclusion Criteria:

- Inflammatory breast cancer

- Prior treatment with VEGF inhibitors (unless in adjuvant setting at least 12 months

Type of Study:


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:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

June 2010

Related Keywords:

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



Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Crestview Hills, Kentucky  41017
Pfizer Investigational Site Detroit, Michigan  48201
Pfizer Investigational Site Rochester, Minnesota  55905
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Federal Way, Washington  98003
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site Columbia, Missouri  65201
Pfizer Investigational Site Asheville, North Carolina  28801
Pfizer Investigational Site Bristol, Tennessee  37620
Pfizer Investigational Site Bismarck, North Dakota  58503