Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer Progressing After Endocrine Treatment

Exclusion Criteria

• •Women who are pregnant or breast-feeding
• •Known HIV infection or Presence of autoimmune disease or other Concurrent non-malignant co-morbidities that are uncontrolled
• •History or symptoms indicative of brain or CNS metastases
• •Prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
• •Documented acute or chronic infection requiring antibiotic treatment
• •Any concurrent chemo-, hormonal, immuno- or corticoid therapy
• •Any prior chemotherapy for advanced or metastatic disease
• •Any concurrent investigational treatment for advanced or metastatic disease
• •History of relevant cardiovascular disease as follows:
• •* Left ventricular ejection fraction (LVEF) below the institution's lower limit of normal, based on echocardiography (ECG) at rest
• •* Uncontrolled or symptomatic congestive heart failure (New York Heart Association (NYHA) \> 2
• •* Uncontrolled or symptomatic arrhythmia and/or angina pectoris
• •* Myocardial infarction during the last 2 years