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Trial of Amrubicin as Treatment for Patients With HER2-Negative Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:
Phase I/II Trial of Amrubicin as Second- or Third-Line Treatment for Patients With HER2-Negative Metastatic Breast Cancer

Clinical Trial Summary

Doxorubicin has been an integral part of the treatment of women with breast cancer for many years. Since amrubicin may have more activity than doxorubicin, as well as less cardiotoxicity, evaluation of amrubicin in the treatment of advanced breast cancer should be a priority. In this Phase II study, the investigators propose an evaluation of single-agent amrubicin as second- or third-line treatment for women with metastatic breast cancer.

Clinical Trial Description

This will be a phase I/II study where phase I will evaluate the maximum tolerated dose of amrubicin, and phase II will assess the progression free survival of patients with HER2-negative metastatic breast cancer using the dose established in the phase I portion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01033032
Study type Interventional
Source SCRI Development Innovations, LLC
Contact
Status Completed
Phase Phase 1/Phase 2
Start date December 2009
Completion date October 2014
View Details
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