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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Intravenous, 25 mg/m2 every 3 weeks
Evaluation of the volumetric reduction in the size of the brain lesion(s).
Institut Jules Bordet
Brussels, Brussels Capital, Belgium
Reduction of brain lesions.
Objective response defined as a \>= 50% volumetric reduction of brain lesions in the absence of increasing steroid use and progressive neurologic symptoms.
Time frame: week 6
Time to whole brain irradiation or radiosurgery
Determine the effect of cabazitaxel on the time to initiating whole brain irradiation or radiosurgery
Time frame: every 6 weeks until disease progression.
Time to developing neurological symptoms.
Determine the effect of cabazitaxel on the time to developing neurological symptoms
Time frame: every 6 weeks until disease progression.
Time to progression in the brain
Determine the effect of cabazitaxel on the time to disease progression in the brain.
Time frame: every 6 weeks until disease progression.
Time to progression extra-cranial
Determine the effect of cabazitaxel on the time to disease progression outside the brain
Time frame: every 6 weeks until disease progression.
Toxicity
Determine the safety of cabazitaxel
Time frame: every 3 weeks until 30 days after last treatment administration.
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