Brain metastasis secondary to HER2-negative breast cancer and NSCLC, not previously irradiated and not requiring immediate radiation. MedDRA version: 16.0 Level: LLT Classification code 10006128 Term: Brain metastases System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.0 Level: PT Classification code 10059282 Term: Metastases to central nervous system System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (in
Conditions
Interventions
Trade Name: Jevtana
Product Name: Cabazitaxel
Product Code: XRP6258
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Cabazitaxel
CAS Number: 183133-96-2
Other descriptiv
Sponsors
Institut Jules Bordet
Eligibility
Sex/Gender
All
Inclusion criteria
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: • Hemoglobin = 9.0g/dL • Absolute neutrophilic count = 1.5 x 109L • Platelet count = 100 x 109L - Adequate hepatic function defined as: • AST = 2.5 x upper limit of normal (ULN) • ALT = 2.5 x ULN • Total bilirubin = 1.0 x ULN - 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 37 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if cabazitaxel can induce a reduction in the size of brain metastasis in metastatic HER2-negative breast cancer and NSCLC with BM who were not previously treated with whole brain irradiation or require immediate brain irradiation;Secondary Objective: - 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 ;Primary end point(s): Objective response defined as a = 50% volumetric reduction of brain lesions in the absence of increasing steroid use, and progressive neurologic symptoms;Timepoint(s) of evaluation of this end point: every 6 weeks (2 cycles) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to whole brain irradiation or radiosurgery - Time to developing neurological symptoms - Time-to-progression in the brain - Time to progression extra-cranial. This will be evaluated separately in the breast and NSCLC cohorts - Objective extra-cranial response rate (if applicable). This will be evaluated separately in the breast and NSCLC cohorts - Toxicity;Timepoint(s) of evaluation of this end point: every 6 weeks (2 cycles) | — |
Countries
Belgium
Contacts
Public ContactBreast Data Centre
Jules Bordet Institute
Outcome results
None listed