TY - JOUR AU - von Hagens, Cornelia AU - Walter-Sack, Ingeborg AU - Goeckenjan, Maren AU - Osburg, Julia AU - Storch-Hagenlocher, Brigitte AU - Sertel, Serkan AU - Elsässer, Michael AU - Remppis, Bjoern Andrew AU - Edler, Lutz AU - Munzinger, Judith AU - Efferth, Thomas AU - Schneeweiss, Andreas AU - Strowitzki, Thomas TI - Prospective open uncontrolled phase I study to define a well-tolerated dose of oral artesunate as add-on therapy in patients with metastatic breast cancer (ARTIC M33/2). JO - Breast cancer research and treatment VL - 164 IS - 2 SN - 1573-7217 CY - Dordrecht [u.a.] PB - Springer Science + Business Media B.V. M1 - DKFZ-2017-01318 SP - 359 - 369 PY - 2017 AB - The antimalarial drug artesunate (ART) is a promising candidate for cancer treatment as it displays anticancer effects in various models. While in short-term treatment of malaria, an excellent safety profile has been found for ART, the potential long-term treatment of cancer patients demands a phase I dose-finding clinical trial determining the daily ART dose which would be well tolerated as add-on therapy.Patients with metastatic breast cancer were to receive either 100 or 150 or 200 mg oral ART daily as add-on to their guideline-based oncological therapy for a study period of four weeks with frequent clinical and laboratory monitoring until 4-8 weeks thereafter. According to the statistical design, recruitment was scheduled in groups of three patients in order not to miss a more than 33 LB - PUB:(DE-HGF)16 C6 - pmid:28439738 DO - DOI:10.1007/s10549-017-4261-1 UR - https://inrepo02.dkfz.de/record/124441 ER -