ZK219477 (Sagopilone) in Patients With Breast Cancer and Brain Metastases

Breast Cancer Clinical Trial

Official title: A Phase 2 Study of ZK219477 (ZK-EPO) in Patients With Breast Cancer and Brain Metastases

Status Terminated

Clinical Trial Summary

The purpose of this research study is to determine the effects (good and bad) of ZK219477(sagopilone) on participants and their cancer. ZK219477 is a chemotherapy drug that is thought to work by interfering with the ability of cancer cells to grow and divide. It is a part of a group of drugs called "epothilones" which appear to cause shrinkage of cancer in some patients with breast cancer. It is generally difficult for chemotherapy to enter the brain. However, it is believed that ZK219477 crosses into the brain. We are also studying whether an investigational MRI scan procedure may eventually help to predict which patients will benefit from ZK219477.

Clinical Trial Description

• Participants will be given ZK219477 intravenously over approximately 30 minutes every three weeks.

• During all treatment cycles a physical exam and questions about the participants general health and specific questions about any problems they may be having will be performed.

• At least every three weeks blood tests will be done to assess the effect of ZK219477 on the body.

• After every 2 cycles of treatment, participants will have additional scans to assess the effect of ZK219477 on their cancer. This will include a CT scan of the abdomen, chest, and pelvis, and an MRI of the brain.

• At the time of the standard MRI, participants will be asked to undergo an additional MRI sequence, which means they will be in the MRI machine for approximately 15-20 more minutes. ;

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• CNS Disease

• NCT number: NCT00496379
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Terminated
• Phase: Phase 2
• Start date: July 2007
• Completion date: January 2012