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 )
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- FACT/GOG-Ntx scores with a change of more than 12 points from the baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
GM1 400mg
Albumin-paclitaxel was administered on Day 1 of each cycle, Q3W. GM1 is administered with D-1,D1,D2 every cycle
干预措施: GM1 (Drug)
Placebo
Albumin-paclitaxel was administered on Day 1 of each cycle, Q3W. Placebo is administered with D-1,D1,D2 every cycle
干预措施: Placebo (Drug)
结局指标
主要结局
FACT/GOG-Ntx scores with a change of more than 12 points from the baseline
时间窗: At the end of Cycle 4 (21day/Cycle）
The proportion of those whose FACT/GOG-Ntx score changed by more than 12 points from the baseline at the end of the fourth cycle of treatment
次要结局
- Assessment of Quality of Life(At the end of Cycle 4 (21day/Cycle）,At the end of Cycle 6 (21day/Cycle）)
- The incidence of grade ≥2 (CTCAE) CIPN(At the end of Cycle 4 (21day/Cycle）,At the end of Cycle 6 (21day/Cycle）)
- Assessment of functional impairment(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(At the end of Cycle 6 (21day/Cycle）)