Clareo Health | A Study of Cabazitaxel for Patients With Breast or Lung Cancer and Recurrent or Progressive Brain Metastases - Cabazitaxel for Brain Metastases (CaBaMet)

1. Prior chemotherapy or targeted therapy (e.g. erlotinib, bevacizumab) for brain metastases

2. Any chemotherapy or targeted tumor therapy within two weeks of study inclusion or concomitantly

3. Any antihormonal tumor treatment within two weeks of study inclusion or concomitantly

4. Time interval to prior external beam radiotherapy less than 2 weeks

5. Suspected or known leptomeningeal disease

6. Peripheral neuropathy ≥ grade 2

7. Inadequate organ and bone marrow function as evidenced by:

* Absolute neutrophil count (ANC) \< 1.5 x 10\*9/L;

* Hemoglobin \< 10.0 g/dL;

* Platelet count \< 100 x 10\*9/L;

* Total bilirubin ≥ 1 x upper limit of normal (ULN);

* AST/GOT and/or ALT/GPT ≥ 1.5 x ULN;

* Serum creatinine \> 1.5 x ULN. If creatinine 1.0 - 1.5 x ULN; creatinine clearance has to be calculated according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula and patients with creatinine clearance \< 60 mL/min must be excluded

8. Other inadequate organ function according to investigator's discretion

9. History of hypersensitivity reaction to docetaxel

10. History of hypersensitivity reaction to polysorbate 80 containing drugs

11. Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)

12. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week washout period is necessary for patients who are already on these treatments; see also Section 10 and Appendix 3 and 4; dexamethasone is allowed)

13. Recently received or planned vaccination against yellow fever during study treatment

14. Pregnant or breast feeding females

15. Participation in any other clinical trial or treatment with any experimental drug within 28 day before enrolment to the study or during study participation until the end of treatment visit

16. Previous or concurrent tumor other than underlying tumor disease (breast or lung cancer) with the exception of cervical cancer in situ, adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder tumors (Ta,Tis, and T1) or any curatively treated tumors \> 5 years prior to enrolment

What this study is about