Spots Global Cancer Trial Database for Taxane Therapy With or Without Bavituximab for the Treatment of HER2-Negative Metastatic Breast Cancer
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Trial Identification
Brief Title: Taxane Therapy With or Without Bavituximab for the Treatment of HER2-Negative Metastatic Breast Cancer
Official Title: An Open-Label, Randomized, Phase II/III Trial of Taxane Therapy With or Without Bavituximab for the Treatment of HER2-Negative Metastatic Breast Cancer
Study ID: NCT02651610
Conditions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Peregrine Pharmaceuticals Investigational Site, Bakersfield, California, United States
Peregrine Pharmaceuticals Investigational Site, Tinley Park, Illinois, United States
Contact Details
Name: Kathy Miller, MD
Affiliation: Indiana University School of Medicine
Role: STUDY_CHAIR
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