Breast Neoplasm
Conditions
Keywords
Metastatic Breast Cancer
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.
Interventions
DRUGTaxol
100 mg/m2/week
Sponsors
Achieve Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rates | Based on enrollment |
| Toxicities | Based on enrollment |
Secondary
| Measure | Time frame |
|---|---|
| Median overall survival | Based on enrollment |
| Progression-free survival | Based on enrollment |
| Time-to-disease progression | Based on enrollment |
Countries
United States
Outcome results
None listed