GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer
Trial Parameters
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.
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) * S