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Phase 2 randomized, placebo-controlled, double blind study of study drug in combination with Docetaxel versus Docetaxel alone for patients with Metastatic Breast Cancer.



Phase 2 randomized, placebo-controlled, double blind study of study drug in combination with Docetaxel versus Docetaxel alone for patients with Metastatic Breast Cancer.

For Condition: Metastatic breast cancer
Status: Recruiting
Sponsor(s): Pfizer ,
Synopsis: The primary purpose of the study is to determine the time to progression of the combination of study drug 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry 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
Total Enrollment: 186

Location and Contact Information:

Pfizer Investigational Site *Recruiting*
Tucson,  Arizona,  85719-4824
United States
Recruiting  

Pfizer Investigational Site *Recruiting*
San Francisco,  California,  94115
United States
Recruiting  


Additional Information:
Study ID Numbers:
  A4061010; 
Study Start Date: November 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00076024

Other Metastatic Breast Cancer Studies:
1. Novel Epothilone (BMS-247550) in Patients with Metastatic Breast Cancer (MBC)

2. Standard Whole Brain Radiation Therapy with Supplemental Oxygen, with or without Concurrent RSR13 (efaproxiral), in Women with Brain Metastases from Breast Cancer

3. An Investigational Drug versus Capecitabine in Male or Female Patients with Advanced Breast Cancer

4. GW572016 For Treatment Of Refractory Metastatic Breast Cancer

5. Novel Epothilone plus Capecitabine versus Capecitabine Alone in Patients with Advanced Breast Cancer

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Phase 2 randomized, placebo-controlled, double blind study of study drug in combination with Docetaxel versus Docetaxel alone for patients with Metastatic Breast Cancer.

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