GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer
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 )
Qilu Pharmaceutical Co., Ltd.
352 participants
Aug 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria7
- 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
Interventions
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 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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06994507