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Evaluation of Cabazitaxel in Patients With Brain Metastasis Secondary to Breast Cancer and NSCLC | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

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

NCT01913067•Jules Bordet Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed informed consent
•Age\>18, ECOG 0-1
•Histologically confirmed 1) HER2-negative invasive breast carcinoma or 2) NSCLC
•In patients with breast cancer, HER2-negative status by FISH or immunohistochemistry (score 0, or +1).
•In patients with breast cancer, known estrogen and progesterone receptor status.
•Evidence of measurable disease in the brain (at least 1cm)
•Stable or decreasing dosage of steroids for 7 days prior to baseline MRI.
•No evidence of (cortical) cognitive impairment as defined by a Mini-Mental Status Exam (MMSE) score ≥ 25/30.
•No more than 4 prior lines of systemic chemotherapy in the metastatic setting
•Adequate hematopoietic function defined as:
+9 more criteria

Exclusion Criteria

•History of prior whole brain irradiation
•Progressive neurological symptoms requiring immediate brain irradiation
•Pregnancy or lactation
•History of hypersensitivity reaction to taxanes
•History of hypersensitivity to polysorbate 80 containing agents
•Current or planned treatment with strong inhibitors or inducers of cytochrome P450.
•Less than 3 weeks since the last treatment of chemotherapy, biological therapy, and/or immunotherapy
•Leptomeningeal carcinomatosis
•Contra-indication to contrast-enhanced MRI

Locations (1)

Institut Jules Bordet

Brussels, Brussels Capital, Belgium

Key Dates

Start Date

September 1, 2013

Primary Completion Date

May 1, 2016

Completion Date

September 1, 2016

Last Updated

July 24, 2014

Conditions

Brain MetastasisBreast CancerNon Small Cell Lung Cancer

Interventions

Cabazitaxel

DRUG

Contrast-enhanced whole brain MRI

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 24, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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