NCT05802342

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

a Multicenter, Randomized, Double-blind Phase II Trial To Evaluate Monosialate Tetrahexose-ganglioside Sodium Injection (GM1) for Prevention of Peripheral Neuropathy in Patients With Breast Cancer Induced by Albumin-bound Paclitaxel Regimen Adjuvant/Neoadjuvant Therapy

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• To Evaluate the Effectiveness of GM1 in the Prevention of Albumin-paclitaxel Therapy Induced Peripheral Neuropathy in Breast Cancer Patients

Interventions

Type	Name	Description
DRUG	Monosialotetrahexose ganglioside sodium injection	The treatment period was GM1/ placebo with albumin-paclitaxel from cycle 1 to cycle 4/6. The treatment period was GM1/ placebo with albumin-paclitaxel. GM1/ placebo was administered every 2 weeks /3 weeks. GM1 / placebo was administered 1 day before administration (D0), on the day of administration (D1) and on the day after administration (D2), and albumin-paclitaxel-based chemotherapy was administered from day 1, with a total of 4/6 cycles of administration. GM1/ placebo was administered every 2 weeks /3 weeks. GM1 / placebo was administered 1 day before administration (D0), on the day of administration (D1) and on the day after administration (D2), and albumin-paclitaxel-based chemotherapy was administered from day 1, with a total of 4/6 cycles of administration.

Timeline

• Start date: 2023-04-20
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2023-04-06
• Last updated: 2023-04-06