Ph 1 ADI-PEG 20 Plus Doxorubicin; Patients With HER2 Negative Metastatic Breast Cancer

HER2 Negative Metastatic Breast Cancer Clinical Trial

Official title: Phase 1 Trial of ADI-PEG 20 Plus Doxorubicin in Patients With HER2 Negative Metastatic Breast Cancer or Advanced Solid Tumor

Status Completed

Clinical Trial Summary

Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol, and has been used to treat patients that have cancers that require arginine. In this study, ADI will be combined with the well known chemotherapy Doxorubicin and the safety and potential efficacy of this combination will be explored in patients with HER2 Negative Metastatic Breast Cancer.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2 Negative Metastatic Breast Cancer

• NCT number: NCT01948843
• Study type: Interventional
• Source: Polaris Group
• Status: Completed
• Phase: Phase 1
• Start date: April 2014
• Completion date: April 2016