An Open-Label, Randomized, Phase II/III Trial of Taxane Therapy With or Without Bavituximab for the Treatment of HER2-Negative Metastatic Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- Taxane
- Conditions
- Metastatic Breast Cancer
- Sponsor
- Peregrine Pharmaceuticals
- Locations
- 1
- Primary Endpoint
- Overall response rate (ORR)
- Status
- Withdrawn
- Last Updated
- 8 years ago
Overview
Brief Summary
The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug taxane, will improve the results of the treatment for HER2-negative metastatic breast cancer.
Detailed Description
This is an open-label randomized trial in patients with HER2-negative metastatic breast cancer. Patients will be treated with either taxane alone (investigator choice of paclitaxel or docetaxel) or taxane with bavituximab. Paclitaxel will be given 3 of 4 weeks, docetaxel will be given once every 3 weeks, and bavituximab will be given weekly. All therapy will continue until disease progression, toxicity, withdrawal or consent, investigator decision, or study termination. Efficacy (overall response rate) is the primary endpoint while safety is the secondary endpoint.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Taxane
Docetaxel on Day 1 of 21-day cycles OR Paclitaxel on Days 1, 8, and 15 of 28-day cycles
Intervention: Taxane
Bavituximab plus taxane
Bavituximab 3 mg/kg weekly PLUS Docetaxel on Day 1 of 21-day cycles OR Paclitaxel on Days 1, 8, and 15 of 28-day cycles
Intervention: Bavituximab
Bavituximab plus taxane
Bavituximab 3 mg/kg weekly PLUS Docetaxel on Day 1 of 21-day cycles OR Paclitaxel on Days 1, 8, and 15 of 28-day cycles
Intervention: Taxane
Outcomes
Primary Outcomes
Overall response rate (ORR)
Time Frame: 24 months
Secondary Outcomes
- Safety Measures - Adverse Events and Laboratory Evaluations(24 months)
- Efficacy: Disease Control Rate (DCR)(24 Months)
- Efficacy: Duration of Response (DOR)(24 Months)
- Efficacy: Progression Free Survival (PFS)(24 Months)
- Efficacy: Overall Survival(24 Months)