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

NCT03002103 Phase 3 SUSPENDED

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

Details

Lead sponsor	SynCore Biotechnology Co., Ltd.
Phase	Phase 3
Status	SUSPENDED
Enrolment	420
Start date	2016-11-23
Completion	2027-06

Conditions

• Triple-Negative Breast Cancer

Interventions

• EndoTAG-1
• Paclitaxel
• Gemcitabine Hydrochloride

Primary outcomes

• PFS — up to 12 months
  Progression free survival defined as the time from randomization to disease progression based on blinded central radiological image evaluation according to response evaluation criteria in solid tumors (RECIST, version 1.1) or death from any cause, whichever occurs first

Countries

Taiwan