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 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.
• 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.