Clinical trial NCT02166658 (phase 2, status: terminated)
Conditions: breast cancer, lung cancer, recurrent brain metastases, progressive brain metastases
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: cabazitaxel
SMILES: [H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)C4=CC=CC=C4)C(C)=C([C@@H](OC)C(=O)[C@]1(C)[C@H](C[C@H]1OC[C@@]21OC(C)=O)OC)C3(C)C
Reason stopped: 
    after a recruitment of more than 2 years, only 8 patients have been registered.
  
Eligibility criteria:

        Inclusion Criteria:

          1. Adult patients (≥ 18 years of age)

          2. Histologically or cytologically confirmed stage IV lung or breast cancer with
             progressive or recurrent brain metastases

          3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          4. Prior external beam radiotherapy (WBRT or SRS) of BM Patients suffering from small
             cell lung cancer (SCLC) who have been treated with chemotherapy and prophylactic
             cranial radiotherapy may be also enrolled.

          5. At least one two-dimensional measurable lesion on brain MRI

          6. Life expectancy at least 3 months

          7. Females of childbearing potential (FCBP) must have a negative pregnancy test within 7
             days of the first application of study treatment and must agree to use effective
             contraceptive birth control measures (Pearl Index < 1) during the course of the Trial.
             A female subject is considered to be of childbearing potential unless she is age ≥ 50
             years and naturally amenorrhoeic for ≥ 2 year, or unless she is surgically sterile.

          8. Males must agree to use effective contraception (Pearl Index < 1) during the course of
             the trial and for at least 6 months after last administration of study medication
             cabazitaxel. In addition males must agree to prevent contact with the ejaculate by
             another person throughout study treatment.

        Exclusion Criteria:

          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