Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005194-32 | EudraCT Number |
Not provided
Not provided
Scientific rationale is deemed obsolete. Funders lost interest in the trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cabazitaxel | Experimental | Eligible patients will receive intravenous 25mg/m2 cabazitaxel every 3 weeks. Contrast-enhanced whole brain MRI will be performed every two cycles. Patients who show ≥50% volumetric reduction in the size of the brain lesion(s) will continue on cabazitaxel until disease progression or unacceptable toxicity. Patients who show evidence of disease progression and/or developed progressive neurological symptoms will be taken off study and offered whole brain irradiation. Patients who do not meet both criteria can have the choice either to continue on study drug or to be taken off study according to the investigator discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabazitaxel | Drug | Intravenous, 25 mg/m2 every 3 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to whole brain irradiation or radiosurgery | Determine the effect of cabazitaxel on the time to initiating whole brain irradiation or radiosurgery | every 6 weeks until disease progression. |
| Time to developing neurological symptoms. |
Not provided
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:
Adequate hepatic function defined as:
Adequate renal function defined as serum creatinine ≤ 1.5 x ULN. If creatinine ranges from 1.0 - 1.5 x ULN, creatinine clearance determined by CKD-EPI formula should be calculated and only patients with clearance >60 mL/min are eligible
Adequate contraceptive method in patients with child-bearing potential.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ahmad Awada, MD, PhD | Institute Jules Bordet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Jules Bordet | Brussels | Brussels Capital | 1000 | Belgium |
Not provided
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D001943 | Breast Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C552428 | cabazitaxel |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Contrast-enhanced whole brain MRI | Procedure | Evaluation of the volumetric reduction in the size of the brain lesion(s). |
|
Determine the effect of cabazitaxel on the time to developing neurological symptoms
| 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. | 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 | every 6 weeks until disease progression. |
| Toxicity | Determine the safety of cabazitaxel | every 3 weeks until 30 days after last treatment administration. |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |