GM1 to prevent nerve damage from albumin-paclitaxel in breast cancer patients.

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 )

This trial will test whether GM1 can prevent peripheral nerve damage in adults with breast cancer who are receiving albumin-paclitaxel chemotherapy.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 352 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Qilu Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT06994507 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled phase III trial that enrolled 352 patients who were assigned 1:1 to receive GM1 or placebo alongside albumin-paclitaxel chemotherapy. The primary endpoint is the proportion of patients with a FACT/GOG-Ntx score change greater than 12 from baseline at the end of GM1 treatment (cycle 4, day 21). Key eligibility included women aged 18–75 with histologically confirmed breast cancer scheduled for adjuvant or neoadjuvant albumin-paclitaxel, ECOG 0–1, adequate organ function, and no preexisting peripheral neuropathy. Safety, neuropathy severity measures, and quality of life were also monitored as secondary outcomes.

Who should consider this trial

Good fit: Adult women (18–75) with confirmed breast cancer scheduled for adjuvant or neoadjuvant albumin-paclitaxel, ECOG 0–1, with adequate organ function and no preexisting peripheral neuropathy are the ideal candidates.

Not a fit: Patients with existing peripheral neuropathy, significant risk factors for neuropathy, uncontrolled diabetes, or a recent history of other malignancies are excluded and unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, GM1 could reduce the rate or severity of chemotherapy-induced peripheral neuropathy, helping patients maintain function and complete planned chemotherapy.

How similar studies have performed: Smaller clinical studies and preclinical data have suggested GM1 may reduce chemotherapy-related neuropathy, but robust phase III evidence specifically for albumin-paclitaxel has been limited.

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

Where this trial is running

Beijing

• The Fifth Medical Center of the Chinese People's Liberation Army General Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: ZeFei Jiang, Chief Physician

Conditions Chemotherapy-induced Peripheral Neuropathy