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

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.