GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer

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

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)
* Symptoms such as muscle pain in the limbs that interfere with the evaluate of peripheral neuropathy;
* Uncontrolled cardiovascular and cerebrovascular system diseases or hypertension
* Active infections that require systematic treatment, including bacteria, fungi or viruses, within one week before first study drug use; Or infectious diarrhea occurred within 4 weeks before the first study drug use;
* Hereditary abnormal glycolipid metabolism, HIV infection or known Acquired Immune Deficiency Syndrome (AIDS); Positive syphilis antibody, active hepatitis B, active hepatitis C

Conditions3

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