To Evaluate the Effectiveness of GM1 in the Prevention of Albumin-paclitaxel Therapy Induced Peripheral Neuropathy in Breast Cancer Patients Clinical Trial
Official title:
a Multicenter, Randomized, Double-blind Phase II Trial To Evaluate Monosialate Tetrahexose-ganglioside Sodium Injection (GM1) for Prevention of Peripheral Neuropathy in Patients With Breast Cancer Induced by Albumin-bound Paclitaxel Regimen Adjuvant/Neoadjuvant Therapy
This randomized, double-blind, multicenter, placebo-controlled Phase II trial was designed to investigate the efficacy and safety of GM1 in the prevention of peripheral neuropathy caused by albumin-bound paclitaxel regimen in breast cancer patients.This study was randomly divided into 3 groups at 1:1:1 with 50 subjects in each group Subjects received study treatment until the end of treatment for a total of 4/6 cycles. The treatment period was GM1/ placebo combined with albumin-bound paclitaxel therapy. GM1 / placebo was administered 1 day before administration (D0), on the day of administration (D1) and on the day after administration (D2), and albumin-bound paclitaxel was administered starting on day D1, with a total of 4/6 cycles.
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