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

NCT ID: NCT06994507

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2027-06-30

Brief 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.

Conditions

Chemotherapy-induced Peripheral Neuropathy (CIPN)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

GM1 400mg

Albumin-paclitaxel was administered on Day 1 of each cycle, Q3W. GM1 is administered with D-1,D1,D2 every cycle

Group Type: EXPERIMENTAL

GM1

Intervention Type: DRUG

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.

Placebo

Albumin-paclitaxel was administered on Day 1 of each cycle, Q3W. Placebo is administered with D-1,D1,D2 every cycle

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

ZeFei Jiang, Chief Physician

Role: CONTACT

jzf_cscobc@csco.org.cn

010-66947175

Facility Contacts

ZeFei Jiang, PHD

Role: primary

jzf-cscobc@csco.org.cn

010-66947175

Other Identifiers

QLGM1-CIPN-301

Identifier Type: -

Identifier Source: org_study_id