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Recruiting Phase 3

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

NCT06994507 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2025-08-01
Last updated
2025-08-06

Condition(s) studied

Chemotherapy-induced Peripheral Neuropathy (CIPN)

Investigational drug(s) / intervention(s)

GM1Placebo

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.

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
The Fifth Medical Center of the Chinese People's Liberation Army General Hospital Beijing China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06994507 on ClinicalTrials.gov ↗ ← All trials in China