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GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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 )

NCT06994507•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.

Detailed Description

This study was randomly divided into two groups at a ratio of 1:1, with 176 subjects in each group. All patients received GM1/ placebo treatment + chemotherapy. The main purpose of this study is to evaluate the effectiveness of GM1 in preventing peripheral neuropathy caused by albumin-paclitaxel chemotherapy. The primary endpoint was the end of GM1 treatment in cycle 4 (C4D21), and the proportion of patients whose FACT/GOG-Ntx score changed by more than 12 points from baseline.

Eligibility

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Voluntarily sign the informed consent form;
•Age: 18 to 75 years old;
•Female patients with breast cancer confirmed byhistological and/or cytological diagnostic basis for breast cancer and are intended to receive adjuvant/neoadjuvant therapy with Albumin paclitaxel regimens;
•ECOG: 0-1
•Adequate organ function level
•Glycated hemoglobin (HbA1c) \< 7.0%;
•For women of childbearing potential: use effective contraceptive measures for contraception from the date of signing the informed consent form until 30 days after the last use of the investigatory drug.
•Patients can accurately record or express the occurrence and severity of peripheral neuropathy through questionnaires.

Exclusion Criteria

•Grade ≥1 peripheral neuropathy (CTCAE grade ≥1) or any of the first 4 items of FACT/GOG-Ntx ≥1;
•There are risk factors for peripheral neuropathy (excluding peripheral neuropathy caused by chemotherapy).
•History of another malignant tumors (except breast cancer)
•Symptoms such as muscle pain in the limbs that interfere with the evaluate of peripheral neuropathy;
•Uncontrolled cardiovascular and cerebrovascular system diseases or hypertension
•Active infections that require systematic treatment, including bacteria, fungi or viruses, within one week before first study drug use; Or infectious diarrhea occurred within 4 weeks before the first study drug use;
•Hereditary abnormal glycolipid metabolism, HIV infection or known Acquired Immune Deficiency Syndrome (AIDS); Positive syphilis antibody, active hepatitis B, active hepatitis C

Locations (1)

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

Beijing, China

Key Dates

Start Date

August 1, 2025

Primary Completion Date

September 1, 2026

Completion Date

June 1, 2027

Last Updated

August 6, 2025

Enrollment

352

ESTIMATED participants

Conditions

Chemotherapy-induced Peripheral Neuropathy (CIPN)

Interventions

GM1

DRUG

Placebo

DRUG

Contacts

ZeFei Jiang, Chief Physician

CONTACT

010-66947175 jzf_cscobc@csco.org.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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