Clinical trial NCT06994507: GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial of GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer（Gypsophila )
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Chemotherapy-induced Peripheral Neuropathy (CIPN)
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-29
Enrollment: 352
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 evaluate the effectiveness of GM1 in preventing peripheral neuropathy caused by albumin-paclitaxel chemotherapy. The primary endpoint was the end of GM1 treatment in cycle 4 (C4D21), and the proportion of patients whose FACT/GOG-Ntx score changed by more than 12 points from baseline.

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

Primary outcomes:
measure: FACT/GOG-Ntx scores with a change of more than 12 points from the baseline
timeFrame: At the end of Cycle 4 (21day/Cycle）
Secondary outcomes:
measure: The incidence of grade ≥2 (CTCAE) CIPN
timeFrame: At the end of Cycle 4 (21day/Cycle）,At the end of Cycle 6 (21day/Cycle）
measure: Assessment of functional impairment
timeFrame: At the end of Cycle 4 (21day/Cycle）,At the end of Cycle 6 (21day/Cycle）
measure: Assessment of Quality of Life
timeFrame: At the end of Cycle 4 (21day/Cycle）,At the end of Cycle 6 (21day/Cycle）
measure: FACT/GOG-Ntx scores with a change of more than 12 points from the baseline
timeFrame: At the end of Cycle 6 (21day/Cycle）
Other outcomes:
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