Status:
TERMINATED
Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer
Lead Sponsor:
Achieve Life Sciences
Conditions:
Breast Neoplasm
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the objective response rates of patients randomized to receive either TOCOSOL(R) Paclitaxel or Taxol(R) (paclitaxel injection) administered every week to patien...
Detailed Description
Female patients with first or second line metastatic breast cancer will be randomized to receive either weekly TOCOSOL Paclitaxel or weekly Taxol (paclitaxel injection). Patients will undergo radiogra...
Eligibility Criteria
Inclusion
- Patients with histologic diagnosis of breast carcinoma
- Stage IV (M1) disease
- Adult (18 years of age or older) patients
Exclusion
- Patients treated with a taxane within the past year
- Patients whose tumor tissue is known to show over expression of HER2/neu
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
821 Patients enrolled
Trial Details
Trial ID
NCT00251095
Start Date
September 1 2005
End Date
September 1 2007
Last Update
June 4 2009
Active Locations (14)
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1
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94704
2
Desert Hematology Oncology Medical Group
Rancho Mirage, California, United States, 92270
3
Stockton Hematology Oncology
Stockton, California, United States, 95204
4
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901