NCT02685306

A Study of Neoadjuvant Paclitaxel in Combination With Bavituximab in Early- Stage Triple- Negative Breast Cancer

A Phase II Study to Determine the Pathological Complete Response Rate and Immunomodulatory Effects of Neoadjuvant Paclitaxel in Combination With Bavituximab in Early- Stage Triple- Negative Breast Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Peregrine Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 early- stage Triple Negative Breast Cancer followed by Standard- of- Care surgery

Detailed description

This is an open-label randomized trial in patients with early- stage Triple Negative Breast Cancer. Patients will be treated with either paciltaxel alone or paclitaxel with bavituximab. Paclitaxel will be given weekly, and bavituximab will be given weekly. All therapy will continue for up to twelve doses of treatment followed by standard of care definitive surgical resection.

Conditions

• Breast Cancer
• Triple Negative Breast Neoplasms
• Triple-Negative Breast Neoplasm
• Triple-Negative Breast Cancer
• Triple Negative Breast Cancer
• ER-Negative PR-Negative HER2-Negative Breast Neoplasms
• ER-Negative PR-Negative HER2-Negative Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Bavituximab	12 weekly doses of bavituximab given on Days 1, 8,15,22,29, 36, 43, 50, 57, 64, 71, 78
DRUG	Taxane	12 weekly doses of taxane on Days 1, 8,15,22,29, 36, 43, 50, 57, 64, 71, 78

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-04-01
• Completion: 2017-09-01
• First posted: 2016-02-18
• Last updated: 2017-03-09