HER-2/neu-negative breast cancer with leptomeningeal spread MedDRA version: 12.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer MedDRA version: 12.0 Level: LLT Classification code 10024233 Term: Leptomeningeal metastases
Conditions
Sponsors
Charité-Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • HER-2/neu-negative breast cancer • leptomeningeal spread • Distance from the last administration of cytostatic therapy of at least 3 weeks, except for the unique application of intrathecal methotrexate 15 mg within one week is allowed before enrollment. • ECOG performance score =2 • no active infection • age =18 years • adequate renal function (Creatinine-Clearance >50 ml/min) • adequate bone marrow reserve (peripheral granulocytes >1500/µl and thrombocytes >80000/µl) • bilirubine up to 3 mg/dl, GOT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • breast cancer without leptomeningeal spread • simultaneous participation in another clinical trial • simultaneous or previous other malignant disease in the past 5 years • treatment with salicylates, beta-lactam antibiotics or non-steroidal antirheumatic agents within one week before start of the MTX-containing treatment • co-morbidities, appearing to make an intensive chemotherapy impossible • large accumulation of extravascular fluid (e.g. pleural effusion, ascites) • radio therapy of the skull or the whole cerebrospinal fluid space • known intolerance to MTX, IFO, or DepoCyte® • pregnant or breastfeeding women • women of childbearing age without highly effective contraception (defined as Pearl-Index <1)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify the rate of neurologic progression after one year in patients with Her-2/neu negative breast cancer and neoplastic meningitis treated with methotrexate, ifosfamide and liposomal cytarabine.;Secondary Objective: To identify the - Time to neurologic progression - Response rate - Time to treatment failure - Overall survival - Toxicity in patients with Her-2/neu negative breast cancer and neoplastic meningitis treated with methotrexate, ifosfamide and liposomal cytarabine.;Primary end point(s): rate of neurological progression after 1 year | — |
Countries
Germany
Outcome results
None listed