NCT06994507 GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer
| NCT ID | NCT06994507 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Condition | Chemotherapy-induced Peripheral Neuropathy (CIPN) |
| Study Type | INTERVENTIONAL |
| Enrollment | 352 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 352 participants in total. It began in 2025-08-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 neuropathy in breast cancer patients treated with Albumin-paclitaxel chemotherapy regimen.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06994507 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Chemotherapy-induced Peripheral Neuropathy (CIPN). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06994507 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 352 participants.
Is NCT06994507 currently recruiting?
Yes, NCT06994507 is actively recruiting participants. Contact the research team at jzf_cscobc@csco.org.cn for enrollment information.
Where is the NCT06994507 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06994507 clinical trial?
NCT06994507 is sponsored by Qilu Pharmaceutical Co., Ltd.. The trial plans to enroll 352 participants.