GM1 Prophylaxis for Nab-paclitaxel-associated Chemotherapy-induced Peripheral Neuropathy (CIPN) in Patients With Breast Cancer

Официальное название

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 )

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат GM1
  GM1 was administered intravenously one day before the administration of each cycle of chemotherapy. The experimental group was given 400 mg of GM1 injection. Administration was carried out at D-1, D1, D2 in each cycle, with a cumulative administration of 3 times per cycle.
• Препарат Placebo
  Placebo was administered intravenously one day before the administration of each cycle of chemotherapy. The control group was given placebo. Administration was carried out at D-1, D1, D2 in each cycle, with a cumulative administration of 3 times per cycle.

Первичные конечные точки

• FACT/GOG-Ntx scores with a change of more than 12 points from the baseline [Срок оценки: At the end of Cycle 4 (21day/Cycle）]

Вторичные конечные точки (4)

• The incidence of grade ≥2 (CTCAE) CIPN [Срок оценки: At the end of Cycle 4 (21day/Cycle）,At the end of Cycle 6 (21day/Cycle）]
• Assessment of functional impairment [Срок оценки: At the end of Cycle 4 (21day/Cycle）,At the end of Cycle 6 (21day/Cycle）]
• Assessment of Quality of Life [Срок оценки: At the end of Cycle 4 (21day/Cycle）,At the end of Cycle 6 (21day/Cycle）]
• FACT/GOG-Ntx scores with a change of more than 12 points from the baseline [Срок оценки: At the end of Cycle 6 (21day/Cycle）]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• The Fifth Medical Center of the Chinese People's Liberation Army General Hospital — Пекин

Идентификаторы

NCT: NCT06994507 · QLGM1-CIPN-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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