study of artesunate in metastatic breast cancer

Conditions: Metastatic Breast Cancer; Locally Advanced Breast Cancer

Summary: the purpose of this study is to evaluation the tolerability of an add-on therapy with artesunate with a duration of 4 weeks in patients with advanced breast cancer.

additional objectives are: * parallel sampling of blood and saliva for the determination of drug concentrations and pharmacokinetic parameters in a substudy on the day of first application and during steady state * attempt to establish a therapeutical drug monitoring * collection of further safety data during prolonged add-on treatments (compassionate use)

Eligibility criteria:
inclusion criteria: * patients with histologically or cytologically confirmed breast cancer * distant metastases or locally advanced breast cancer * age ≥ 18 years * ecog performance ≤ 2 * life expectancy of at least 6 months * written informed consent * individual standard therapy according to guidelines * oral intake of trial medication possible * compliance with study procedures * women of childbearing potential: negative pregnancy test before start of medication * use of a highly effective method of birth control during intake of add-on therapy for women of childbearing potential being sexually active inclusion criteria for extended treatment phase: * participant of the phase i study artic m33/2 who had tolerated the study medication for 4±1 weeks without clinically relvant adverse events or after improvement to ≤ grade 2 * participant of the phase i study artic m33/2 with possible benefit by continuation or restart of the add-on therapy after a next progression according to current scientific knowledge * written informed consent for extended treatment phase * consent of the responsible oncologist * compliance for further intake and follow-up expected inclusion criteria for individual compassionate use: * participant of the phase i study artic m33/2 * available standard therapies have minimal or only short activity or intolerable side effects * written informed consent for compassionate use * consent of the responsible oncologist 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 exclusion criteria for extended treatment phase: * 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 exclusion criteria for individual compassionate use: - intolerable health risks by re-exposition with the study medication

Keywords: phase i safety