GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Chemotherapy-induced Peripheral Neuropathy (CIPN)
In brief
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.
Key facts
- Study ID
- NCT06994507
- Run by
- Qilu Pharmaceutical Co., Ltd.
- People needed
- 352
- Starts
- 2025-08-01
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2025-08-06
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- The Fifth Medical Center of the Chinese People's Liberation Army General Hospital — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.