Triple-Negative Breast Cancer Clinical Trial
Official title:
An Open-label, Randomized, Controlled Phase III Trial Evaluating the Efficacy and Safety of EndoTAG®-1 in Combination With Paclitaxel and Gemcitabine Compared With Paclitaxel and Gemcitabine as First-line Therapy in Patients With Visceral Metastatic Triple-negative Breast Cancer
This is a prospective, multicenter, open-label, randomized, and controlled trial to test the superiority of EndoTAG®-1 in combination with paclitaxel and gemcitabine versus paclitaxel in combination with gemcitabine. An independent data safety monitoring board (DSMB) will be established to decide on the recommended dose (RD) of EndoTAG®-1, paclitaxel and gemcitabine to be used throughout the trial and to monitor the patients' safety and treatment efficacy data
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