NCT01913067

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

A Phase II Evaluating Cabazitaxel in Patients With Brain Metastasis Secondary to Breast and Non-small Cell Lung Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jules Bordet Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Brain Metastasis
• Breast Cancer
• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Cabazitaxel	Intravenous, 25 mg/m2 every 3 weeks
PROCEDURE	Contrast-enhanced whole brain MRI	Evaluation of the volumetric reduction in the size of the brain lesion(s).

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-05-01
• Completion: 2016-09-01
• First posted: 2013-07-31
• Last updated: 2014-07-24

Locations

1 site across 1 country: Belgium