MediGene successfully completes patient recruitment into EndoTAG(TM)-1 Phase II breast cancer trial
MediGene AG has successfully completed patient recruitment into its randomized Phase II trial of EndoTAG(TM)-1 for the treatment of triple receptor-negative breast cancer. Results will be available as scheduled in the first six months of 2010. This multinational clinical trial is being conduced across more than 20 centres in Europe and India.
The trial was designed to enrol patients suffering from hormone receptor and HER-2-recepor negative breast cancer who have metastastatic disease. The trial recruited 135 patients divided into three groups: EndoTAG(TM)-1 alone, EndoTAG(TM)-1 in combination with a cytotoxic drug or the cytotoxic drug alone. The study will assess safety, tolerability and efficacy. The primary endpoint of the trial is progression-free survival after 16 weeks,.
Dr. Axel Mescheder, CSO & CDO of MediGene AG, commented: "The completion of patient recruitment in this important trial is another key milestone for MediGene which also shows the high degree of acceptance of this treatment among physicians and patients. It also ensures that we will be able to conclude the trial within the projected time frame. This controlled trial has been powered to allow the assessment of both the efficacy and the safety of EndoTAG(TM)-1 in this very difficult to treat cancer population."
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