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
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;
Parallel
GM1
DrugGM1 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
DrugPlacebo 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.
FACT/GOG-Ntx scores with a change of more than 12 points from the baseline
The proportion of those whose FACT/GOG-Ntx score changed by more than 12 points from the baseline at the end of the fourth cycle of treatment
The incidence of grade ≥2 (CTCAE) CIPN
The incidence of grade ≥2 (CTCAE) CIPN
Assessment of functional impairment
Vibration sensitivity test and Grooved pegboard test
Assessment of Quality of Life
Assessment of Quality of Life（QLQ C30）
FACT/GOG-Ntx scores with a change of more than 12 points from the baseline
The proportion of those whose FACT/GOG-Ntx score changed by more than 12 points from the baseline at the end of the sixth cycle of treatment
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