Status:
RECRUITING
GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
Chemotherapy-induced Peripheral Neuropathy (CIPN)
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief 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 neur...
Detailed Description
This study was randomly divided into two groups at a ratio of 1:1, with 176 subjects in each group. All patients received GM1/ placebo treatment + chemotherapy. The main purpose of this study is to e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT06994507
Start Date
August 1 2025
End Date
June 1 2027
Last Update
August 6 2025
Active Locations (1)
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1
The Fifth Medical Center of the Chinese People's Liberation Army General Hospital
Beijing, China