drugset / Trial / NCT01913067

Evaluation of Cabazitaxel in Patients With Brain Metastasis Secondary to Breast Cancer and NSCLC

NCT01913067

NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2013-09
Primary completion
2016-05
Completion
2016-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Cabazitaxel Other / unclassified 25 mg/m2 Intravenous