Study of Artesunate in Metastatic Breast Cancer

Exclusion Criteria

• •Allergy to artesunate or to other artemisinin derivatives
• •Concurrent conditions interfering with patient safety
• •Communication problems
• •Concurrent participation in another clinical trial or 4 weeks prior to recruitment
• •Participation in a clinical trial with an unapproved drug 6 months prior to recruitment
• •Sinus bradycardia, bradyarrhythmia
• •AV-Block II° and III°
• •QTc \> 500 msec
• •Previously known long QT-syndrome
• •Concurrent intake of a medication with clinically relevant neurotoxicity or during 30 days prior to recruitment
• •Relevant neurological symptoms which might complicate the evaluation of the compatibility of the IMPD (f. e. cerebral metastases) or might be subject to worsening during intake of the IMPD
• •Radiotherapy 2 weeks prior of the intake of the IMPD
• •Concurrent intake of supplements or any other medication with unapproved efficacy f.e. vitamins, minerals or others (OTC)
• •Pregnancy and lactation
• •Ineffective mode of contraception in women of childbearing potential
• •Clinically relevant adverse Events during the first 4 weeks of intake of study medication possibly, probably or definitely related to the study medication
• •Intolerable health risks by continuation re-exposition with the study medication
• •Continuation or re-exposition is medically not acceptable after consultation of physicians responsible for their standard therapy
• •\- Intolerable health risks by re-exposition with the study medication