A Multicenter Phase 3, Randomized Comparison of the Safety and Efficacy of Weekly TOCOSOL(R) Paclitaxel vs. Weekly Paclitaxel Injection in the Treatment of Metastatic Breast Cancer
18 Years
N/A
Female
Breast Neoplasm
Trial Information
A Multicenter Phase 3, Randomized Comparison of the Safety and Efficacy of Weekly TOCOSOL(R) Paclitaxel vs. Weekly Paclitaxel Injection in the Treatment of Metastatic Breast Cancer
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 radiographic imaging of their disease to assess response to therapy. The
primary endpoint of this study is a comparison of the objective response rates observed in
patients receiving TOCOSOL Paclitaxel, to those receiving Taxol. Time-to-disease progression
and overall survival will also be compared. The toxicities of the two treatment regimens
will be compared.
Inclusion Criteria:
- Patients with histologic diagnosis of breast carcinoma
- Stage IV (M1) disease
- Adult (18 years of age or older) patients
Exclusion Criteria:
- Patients treated with a taxane within the past year
- Patients whose tumor tissue is known to show over expression of HER2/neu
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective response rates
Outcome Time Frame:
Based on enrollment
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
SON-8184-1075
NCT ID:
NCT00251095
Start Date:
September 2005
Completion Date:
September 2007
Related Keywords:
- Breast Neoplasm
- Metastatic Breast Cancer
- Breast Neoplasms
- Neoplasms
Name | Location |
|---|---|
| Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
| Florida Cancer Specialists | Fort Myers, Florida 33901 |
| Alta Bates Comprehensive Cancer Center | Berkeley, California 94704 |
| Mid Dakota Clinic | Bismarck, North Dakota 58501 |
| Essex Oncology of North Jersey | Belleville, New Jersey 07109 |
| The Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
| Desert Hematology Oncology Medical Group | Rancho Mirage, California 92270 |
| Hematology Oncology Consultants, Inc | Columbus, Ohio 43235 |
| Stockton Hematology Oncology | Stockton, California 95204 |
| Mountain State Tumor Institute | Boise, Idaho 83712 |
| Southfield Oncology Institute, Inc | Southfield, Michigan 48076 |
| Oncology Care Associates | St Joseph, Michigan 49085 |
| Norris Cotton Cancer Center, Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
| Chattanooga Oncology & Hematology Associates, PC | Chattanooga, Tennessee 37404 |
