Actively Recruiting
GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2025-08-06
352
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form
- Female patients aged 18 to 75 years
- Confirmed breast cancer diagnosis by histological and/or cytological methods
- Planned treatment with Albumin-paclitaxel chemotherapy regimen
- ECOG performance status of 0-1
- Adequate organ function
- Glycated hemoglobin (HbA1c) below 7.0%
- Women of childbearing potential agree to use effective contraception from consent until 30 days after last investigational drug use
- Ability to accurately report peripheral neuropathy symptoms via questionnaires
You will not qualify if you...
- Presence of grade 1 or higher peripheral neuropathy or FACT/GOG-Ntx score indicating neuropathy
- Risk factors for peripheral neuropathy unrelated to chemotherapy
- History of other malignant tumors besides breast cancer
- Muscle pain in limbs interfering with neuropathy evaluation
- Uncontrolled cardiovascular or cerebrovascular diseases or hypertension
- Active infections requiring systemic treatment within one week before study drug use
- Infectious diarrhea within four weeks before study drug use
- Hereditary abnormal glycolipid metabolism, HIV/AIDS, positive syphilis antibody, active hepatitis B or C infection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Fifth Medical Center of the Chinese People's Liberation Army General Hospital
Beijing, China
Actively Recruiting
Research Team
Z
ZeFei Jiang, Chief Physician
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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