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