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RECRUITING
NCT06994507
PHASE3

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

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial of GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer(Gypsophila )

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

352

Start Date

2025-08-01

Completion Date

2027-06

Last Updated

2025-08-06

Healthy Volunteers

No

Interventions

DRUG

GM1

GM1 was administered intravenously one day before the administration of each cycle of chemotherapy. The experimental group was given 400 mg of GM1 injection. Administration was carried out at D-1, D1, D2 in each cycle, with a cumulative administration of 3 times per cycle.

DRUG

Placebo

Placebo was administered intravenously one day before the administration of each cycle of chemotherapy. The control group was given placebo. Administration was carried out at D-1, D1, D2 in each cycle, with a cumulative administration of 3 times per cycle.

Locations (1)

The Fifth Medical Center of the Chinese People's Liberation Army General Hospital

Beijing, China