Taxane Therapy With or Without Bavituximab for the Treatment of HER2-Negative Metastatic Breast Cancer

Phase 2

Withdrawn

• Conditions: Metastatic Breast Cancer
• Interventions: Biological: Bavituximab; Drug: Taxane

• Registration Number: NCT02651610
• Lead Sponsor: Peregrine Pharmaceuticals

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-29
• Study First Submitted QC: 2016-01-08
• Study First Posted: 2016-01-11
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-07
• Last Update Posted: 2017-07-11
• Primary Completion: 2017-12
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bavituximab plus taxane	Bavituximab	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
Bavituximab plus taxane	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
Taxane	Taxane	Docetaxel on Day 1 of 21-day cycles OR Paclitaxel on Days 1, 8, and 15 of 28-day cycles

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	24 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Peregrine Pharmaceuticals Investigational Site; 🇺🇸 Tinley Park, Illinois, United States