Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer
- Registration Number
- NCT00251095
- Lead Sponsor
- Achieve Life Sciences
- 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 patients with metastatic breast cancer. The study hypothesis is that the objective response rate with TOCOSOL Paclitaxel given every week is non-inferior to that observed with Taxol given every week.
- 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 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 821
- Patients with histologic diagnosis of breast carcinoma
- Stage IV (M1) disease
- Adult (18 years of age or older) patients
- Patients treated with a taxane within the past year
- Patients whose tumor tissue is known to show over expression of HER2/neu
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TOCOSOL TOCOSOL Paclitaxel TOCOSOL Paclitaxel Taxol Taxol Taxol 80mg/m2/week
- Primary Outcome Measures
Name Time Method Objective response rates Based on enrollment Toxicities Based on enrollment
- Secondary Outcome Measures
Name Time Method Median overall survival Based on enrollment Progression-free survival Based on enrollment Time-to-disease progression Based on enrollment
Trial Locations
- Locations (14)
Stockton Hematology Oncology
🇺🇸Stockton, California, United States
Joe Arrington Cancer Research and Treatment Center
🇺🇸Lubbock, Texas, United States
Alta Bates Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Mountain State Tumor Institute
🇺🇸Boise, Idaho, United States
Southfield Oncology Institute, Inc
🇺🇸Southfield, Michigan, United States
Chattanooga Oncology & Hematology Associates, PC
🇺🇸Chattanooga, Tennessee, United States
The Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Desert Hematology Oncology Medical Group
🇺🇸Rancho Mirage, California, United States
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States
Norris Cotton Cancer Center, Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Oncology Care Associates
🇺🇸St Joseph, Michigan, United States
Essex Oncology of North Jersey
🇺🇸Belleville, New Jersey, United States
Mid Dakota Clinic
🇺🇸Bismarck, North Dakota, United States
Hematology Oncology Consultants, Inc
🇺🇸Columbus, Ohio, United States