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Clinical Trial Summary

A phase II trial evaluating Cabazitaxel in patients with brain metastasis secondary to breast and non-small-cell lung cancer (NSCLC).

OBJECTIVES:

Primary:

The purpose of this study is to determine if cabazitaxel can induce a reduction in the size brain metastasis in metastatic HER2-negative breast cancer and NSCLC with brain metastasis who were not previously treated with whole brain irradiation or require immediate brain irradiation.

Secondary:

- To determine the effect of cabazitaxel on the time to initiating whole brain irradiation or radiosurgery

- To determine the effect of cabazitaxel on the time to developing neurological symptoms

- To determine the effect of cabazitaxel on the time to disease progression in the brain

- To determine the effect of cabazitaxel on the time to disease progression outside the brain. This will be evaluated separately for the breast and NSCLC cohorts To determine the objective extra-cranial response (if applicable). This will be evaluated separately in the breast and NSCLC cohorts

- To determine the safety of cabazitaxel


Clinical Trial Description

This is a single arm, prospective trial using a 2-stage Simon design, in which eligible patients will receive intravenous cabazitaxel for two cycles followed by response evaluation. Based on the pre-specified criteria of response (intra-cranial, patient will be allowed to continue on study drug. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT01913067
Study type Interventional
Source Jules Bordet Institute
Contact
Status Withdrawn
Phase Phase 2
Start date September 2013
Completion date September 2016

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