Overview

A Multicenter, Randomized, Double-blind Phase II Trial to Evaluate GM1 Prevention of Peripheral Neuropathy in Patients With Breast Cancer

Status:
Not yet recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
This randomized, double-blind, multicenter, placebo-controlled Phase II trial was designed to investigate the efficacy and safety of GM1 in the prevention of peripheral neuropathy caused by albumin-bound paclitaxel regimen in breast cancer patients.This study was randomly divided into 3 groups at 1:1:1 with 50 subjects in each group Subjects received study treatment until the end of treatment for a total of 4/6 cycles. The treatment period was GM1/ placebo combined with albumin-bound paclitaxel therapy. GM1 / placebo was administered 1 day before administration (D0), on the day of administration (D1) and on the day after administration (D2), and albumin-bound paclitaxel was administered starting on day D1, with a total of 4/6 cycles.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.