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

Launched by QILU PHARMACEUTICAL CO., LTD. · May 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a drug called GM1 can help prevent a side effect known as chemotherapy-induced peripheral neuropathy (CIPN) in women with breast cancer who are receiving a specific type of chemotherapy called Albumin-paclitaxel. CIPN can cause symptoms like tingling, numbness, or pain in the hands and feet, which can make it difficult for patients to go about their daily lives. The trial will involve women aged 18 to 75 who have breast cancer and are planning to undergo chemotherapy treatment. Participants will be randomly assigned to receive either GM1 or a placebo (a substance with no active medication) without knowing which one they are getting, to see how effective GM1 is in preventing these side effects.

To be eligible for this trial, women must have a confirmed diagnosis of breast cancer and be in good overall health, with specific criteria regarding their organ function and blood sugar levels. They must also be able to communicate their experiences of peripheral neuropathy through questionnaires. It's important to note that women who have certain health conditions or other types of cancer, as well as those with active infections or severe neuropathy, will not be able to participate. If you join the trial, you will have regular check-ins to monitor your health and any side effects you may experience. This study is not yet recruiting participants, but it aims to provide critical information that could improve treatment outcomes for breast cancer patients.

Gender

FEMALE

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)
• • 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