A Multicentre Phase I-II Study to Investigate the Combination of Bendamustine With Weekly Paclitaxel as First or Second Line Therapy in Patients With Metastatic Breast Cancer

Inclusion Criteria

• •Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures;
• •Pathological confirmed primary carcinoma of the breast.
• •Locally advanced or metastatic disease
• •Up to one previous palliative chemotherapy that did not contain docetaxel or paclitaxel. Previous adjuvant treatment with taxanes is allowed when the last application of the taxane was given at least 1 year before entering the trial.
• •Patients must have either measurable or non-measurable lesions according to the WHO criteria
• •At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiated field or there must be pathological proof of progressive disease.
• •Complete radiological and clinical tumor assessment within 4 weeks prior to registration performed as clinically indicated
• •Karnofsky-Index ≥ 60 %
• •Age ≥ 18 years
• •Absolute neutrophil count ≥ 1,500 cells/µl, platelets ≥ 100,000/µl, and hemoglobin ≥ 9 g/dl
• •Bilirubin within normal limits; evaluation of transaminases and alkaline phosphatase ≤ 5x upper normal limit
• •Serum creatinine ≤ 2.0 mg/dl
• •Normal left ventricular ejection fraction (LVEF) by echocardiogramme
• •Patients of childbearing potential, pregnancy test must be negative
• •If fertile effective contraception must be used throughout the study