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

NCT06994507 | Recruiting Phase 3

• 1 other identifier: QLGM1-CIPN-301
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy (CIPN)

Outcome Measures

Primary Outcomes (1)

• FACT/GOG-Ntx scores with a change of more than 12 points from the baseline

  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

  At the end of Cycle 4 (21day/Cycle）

Secondary Outcomes (4)

• The incidence of grade ≥2 (CTCAE) CIPN

  At the end of Cycle 4 (21day/Cycle）,At the end of Cycle 6 (21day/Cycle）

• Assessment of functional impairment

  At the end of Cycle 4 (21day/Cycle）,At the end of Cycle 6 (21day/Cycle）

• Assessment of Quality of Life

  At the end of Cycle 4 (21day/Cycle）,At the end of Cycle 6 (21day/Cycle）

• FACT/GOG-Ntx scores with a change of more than 12 points from the baseline

  At the end of Cycle 6 (21day/Cycle）

Study Arms (2)

GM1 400mg

EXPERIMENTAL

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

Drug: GM1

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

GM1 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.

GM1 400mg

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

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

Beijing, China

RECRUITING

Central Study Contacts

ZeFei Jiang, Chief Physician

CONTACT

010-66947175; jzf_cscobc@csco.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 29, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-05

Locations

CN (1)