Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Jules Bordet Institute
With
Sanofi
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
