Breast Cancer Clinical Trial
Official title:
A Phase II Evaluating Cabazitaxel in Patients With Brain Metastasis Secondary to Breast and Non-small Cell Lung Cancer
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
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. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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