Overview

A 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

Status:
Recruiting

Trial end date:
2024-06-01

Target enrollment:

Participant gender:

Summary

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

Phase:

Phase 3

Details

Lead Sponsor:

SynCore Biotechnology Co., Ltd.

Treatments:

Albumin-Bound Paclitaxel
Gemcitabine
Paclitaxel