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

Phase 3

Not yet recruiting

• Conditions: Chemotherapy-induced Peripheral Neuropathy (CIPN)
• Interventions: Drug: GM1; Drug: Placebo

• Registration Number: NCT06994507
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-19
• Study First Submitted QC: 2025-05-27
• Last Update Submitted: 2025-05-27
• Study First Posted: 2025-05-29
• Last Update Posted: 2025-05-29
• Study Start: 2025-07
• Primary Completion: 2026-09
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 352

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GM1 400mg	GM1	Albumin-paclitaxel was administered on Day 1 of each cycle, Q3W. GM1 is administered with D-1,D1,D2 every cycle
Placebo	Placebo	Albumin-paclitaxel was administered on Day 1 of each cycle, Q3W. Placebo is administered with D-1,D1,D2 every cycle

Primary Outcome Measures

Name	Time	Method
FACT/GOG-Ntx scores with a change of more than 12 points from the baseline	At the end of Cycle 4 (21day/Cycle）	The proportion of those whose FACT/GOG-Ntx score changed by more than 12 points from the baseline at the end of the fourth cycle of treatment

Secondary Outcome Measures

Name	Time	Method
Assessment of Quality of Life	At the end of Cycle 4 (21day/Cycle）,At the end of Cycle 6 (21day/Cycle）	Assessment of Quality of Life（QLQ C30）
Assessment of functional impairment	At the end of Cycle 4 (21day/Cycle）,At the end of Cycle 6 (21day/Cycle）	Vibration sensitivity test and Grooved pegboard test
FACT/GOG-Ntx scores with a change of more than 12 points from the baseline	At the end of Cycle 6 (21day/Cycle）	The proportion of those whose FACT/GOG-Ntx score changed by more than 12 points from the baseline at the end of the sixth cycle of treatment
The incidence of grade ≥2 (CTCAE) CIPN	At the end of Cycle 4 (21day/Cycle）,At the end of Cycle 6 (21day/Cycle）	The incidence of grade ≥2 (CTCAE) CIPN