About this trial
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
Qualifiers
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
Disqualifiers
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;
Trial design
Treatments tested in this trial
- GM1
- Placebo