drugset / Trial / NCT06994507

GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer

NCT06994507 ↗

Phase 3 Recruiting 352 enrolled Qilu Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This study is a randomized, double-blind, multicenter, placebo-controlled phase III clinical trial, aiming to evaluate the efficacy and safety of GM1 in preventing chemotherapy-induced peripheral neuropathy in breast cancer patients treated with Albumin-paclitaxel chemotherapy regimen.

Timeline

Start
2025-08-01
Primary completion
2026-09
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Subject GM1 Unknown 400 mg Intravenous