Cyclosporine A in Combination With Nab-Paclitaxel in Patients With Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title: A Phase I, Open-label, Study of the Safety and Tolerability of Cyclosporine A (CsA) in Combination With Nab-paclitaxel in Patients With Metastatic Breast Cancer

Status Completed

Clinical Trial Summary

The purpose of this research study is to evaluate the safety of therapy with nab-paclitaxel and CsA and if the addition of Cyclosporine A (CsA) to nab-paclitaxel helps stop cancer cells as well as or better than nab-paclitaxel alone.

Clinical Trial Description

Treatment for metastatic breast cancer commonly involves the use of the chemotherapy drug nab-paclitaxel. Nab-paclitaxel is a special preparation of paclitaxel inside a protein layer of albumin. Other studies have shown Cyclosporine A (CsA) may block the progression of advanced breast cancer. The combination of nab-paclitaxel and CsA is considered investigational which means it has not been approved by the US Food and Drug Administration, FDA. Participants on this study will receive nab-paclitaxel through a vein in the arm weekly 3 weeks out of 4, in the outpatient clinic. On the same day as the first infusion of nab-paclitaxel, participants will begin taking CsA tablets twice a day by mouth. Participants will continue to receive study treatment as long as their tumor responds. If the tumor does not respond or the participant experience severe side effects from study treatment, she will be removed from the study and offered other therapies, if that is appropriate. ;

Study Design

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

• NCT number: NCT00983424
• Study type: Interventional
• Source: Northwestern University
• Status: Completed
• Phase: Phase 1
• Start date: February 2010
• Completion date: May 2013