Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
821 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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