The primary purpose of the study is to determine the time to progression of the combination of study drug (AG-013736) and docetaxel versus docetaxel alone in patients who have not received prior chemotherapy for metastatic breast cancer. The secondary purpose of the study is to determine the dose of study drug that can be given with docetaxel administered on an every 3 week schedule.

Condition	Treatment or Intervention	Phase
Breast Cancer	Drug: AG-013736 /Docetaxel  Drug: Docetaxel	Phase II

Further Study Details: 

Expected Total Enrollment:  168

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Criteria

• Female patients with histologically/cytologically proven metastatic breast carcinoma (stage IV, or recurrent with local or regional spread or distant metastatic disease)
• No prior chemotherapy for metastatic disease or adjuvent chemotherapy given within the past 12 months
• No uncontrolled brain metastases
• Adequate bone marrow, liver, and renal function
• No evidence of preexisting uncontrolled hypertension
• ECOG performance status of 0, 1, 2
• At least one target lesions, as defined by RECIST
• Adults at least 18 years of age
• Negative serum pregnancy test for patients of child bearing potential
• Life expectancy at least 12 weeks
• Written informed consent

Call:      734-622-7600    ClinicalTrials.gov@Pfizer.com

Arizona
      Pfizer Investigational Site, Tucson,  Arizona,  85719-4824,  United States; Recruiting
California
      Pfizer Investigational Site, San Francisco,  California,  94115,  United States; Recruiting
      Pfizer Investigational Site, Arroyo Grande,  California,  93420,  United States; Recruiting
      Pfizer Investigational Site, Montebello,  California,  90640,  United States; Recruiting
      Pfizer Investigational Site, Los Angeles,  California,  90018,  United States; Recruiting
      Pfizer Investigational Site, Los Angeles,  California,  90048,  United States; Recruiting
      Pfizer Investigational Site, Los Angeles,  California,  90211,  United States; Recruiting
Florida
      Pfizer Investigational Site, Melbourne,  Florida,  32901,  United States; Not yet recruiting
      Pfizer Investigational Site, Orange Park,  Florida,  32073,  United States; Recruiting
      Pfizer Investigational Site, Palatka,  Florida,  32177,  United States; Recruiting
      Pfizer Investigational Site, St. Augustine,  Florida,  32086,  United States; Recruiting
      Pfizer Investigational Site, Jacksonville Beach,  Florida,  32250,  United States; Recruiting
      Pfizer Investigational Site, Jacksonville,  Florida,  32223,  United States; Recruiting
      Pfizer Investigational Site, Jacksonville,  Florida,  32207,  United States; Recruiting
      Pfizer Investigational Site, Jacksonville,  Florida,  32204,  United States; Recruiting
      Pfizer Investigational Site, Jacksonville,  Florida,  32218,  United States; Recruiting
Illinois
      Pfizer Investigational Site, Chicago,  Illinois,  60637,  United States; Recruiting
      Pfizer Investigational Site, Chicago,  Illinois,  60612,  United States; Recruiting
Ohio
      Pfizer Investigational Site, Cleveland,  Ohio,  44195,  United States; Recruiting
Oregon
      Pfizer Investigational Site, Corvallis,  Oregon,  97330,  United States; Recruiting
      Pfizer Investigational Site, Portland,  Oregon,  97213,  United States; Recruiting
      Pfizer Investigational Site, Portland,  Oregon,  97225,  United States; Recruiting
Canada
      Pfizer Investigational Site, Quebec,  G1S 4L8,  Canada; Recruiting
Canada, Alberta
      Pfizer Investigational Site, Edmonton,  Alberta,  T6G 1Z2,  Canada; Recruiting
Canada, Quebec
      Pfizer Investigational Site, Montreal,  Quebec,  H2L 4M1,  Canada; Recruiting
Germany
      Pfizer Investigational Site, Freiburg,  79106,  Germany; Recruiting
      Pfizer Investigational Site, Frankfurt,  60389,  Germany; Recruiting
      Pfizer Investigational Site, Hamburg,  20099,  Germany; Recruiting
Germany, Sachsen-Anhalt
      Pfizer Investigational Site, Halle,  Sachsen-Anhalt,  06110,  Germany; Recruiting
Italy
      Pfizer Investigational Site, Roma,  00144,  Italy; Recruiting
Spain
      Pfizer Investigational Site, Girona,  17007,  Spain; Recruiting
      Pfizer Investigational Site, Madrid,  28040,  Spain; Recruiting
      Pfizer Investigational Site, Valencia,  46009,  Spain; Recruiting
Spain, Barcelona
      Pfizer Investigational Site, Sabadell,  Barcelona,  08208,  Spain; Recruiting

Study ID Numbers:  A4061010
Record last reviewed:  March 2005
Last Updated:  March 15, 2005
Record first received:  January 12, 2004
ClinicalTrials.gov Identifier:  NCT00076024
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08