NCT03862144已完成2 期
One Day Antiemetic Prophylaxis of NEPA (Netupitant Plus Palonosetron) and Dexamethasone to Prevent Chemotherapy-induced Nausea and Vomiting (CINV) in Breast Cancer Patients Receiving an AC-based Chemotherapy Regimen
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Complete response
研究概览
简要总结
This study evaluates if the activity of one-day of NEPA plus dexamethasone, to prevent chemotherapy-induced nausea and vomiting in breast cancer patients receiving adjuvant AC-based chemotherapy, is maintained during all the chemotherapy cycle treatment (maximum 4 cycles).
详细描述
Patients included in the study should be treated with the following antiemetic prophylaxis, during all the AC-based chemotherapy cycles, up to a maximum of 4 cycles:
- NEPA will be administered orally at the dose of 300 mg netupitant/0.5 palonosetron 1 hour before the start of any chemotherapy cycle.
- Dexamethasone 12 mg will be added on day 1 only of each cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥ 18 years old
- •Histologically or cytologically confirmed diagnosis of breast cancer
- •Naïve patients
- •Be scheduled to receive adjuvant chemotherapy with anthracycline (doxorubicin or epirubicin) + cyclophosphamide (AC-based regimen)
- •ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- •Body Mass index (BMI) ≥ 18.5
- •Written informed consent
- •If women of childbearing potential age: reliable contraceptive measures must be used during the study treatment period and up to 30 days after last NEPA administration
- •Acceptable hepatic function (<= 2 times the upper limit of normal for liver transaminases) and renal function (creatinine < 1.5 times the upper limit of normal);
- •Ability and willingness of the patient to complete the diary.
排除标准
- •Advanced/metastatic breast cancer
- •Patients already submitted to non-AC-based chemotherapy
- •Treatment with investigational medications in 30 days before NEPA
- •Myocardial infarction within the last 6 months
- •Documented or known hypersensitivity to 5HT3RA (5-Hydroxytryptamine Receptor 3 Antagonists) or NK1RA (Neurokinin-1 Receptor Antagonists) and excipients
- •Uncontrolled diabetes mellitus
- •Nausea and vomiting at baseline
- •Chronic use of other antiemetic agent(s)
- •Patient's inability to take oral medication
- •Gastrointestinal obstruction or active peptic ulcer
- •Pregnancy or breastfeeding
- •Prior malignancies at other sites except surgically treated non-melanoma skin cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for ≥ 5 years
- •Psychiatric or CNS (Central Nervous System) disorders interfering with ability to comply with study protocol
研究组 & 干预措施
Netupitant/Palonosetron & Dexamethasone
Experimental
- Netupitant/Palonosetron (NEPA) will be administered orally at the dose of 300 MG (milligrams) netupitant/0.5 palonosetron 1 hour before the start of any chemotherapy cycle.
- Dexamethasone 12 mg will be added on day 1 only of each cycle.
干预措施: Netupitant/Palonosetron (Drug)
结局指标
主要结局
Complete response
时间窗: During the overall phase (From day 1 to day 5 after any AC-based chemotherapy administration) for a maximum 4 cycles (each cycle is 21 days)
The rate of patients achieving and maintaining a complete response (defined as no emetic episode and no use of rescue medication) during the overall phase of all AC-based chemotherapy cycles
次要结局
- Acute and Delayed Phase Complete Response(During the Acute Phase [0-24 hours after chemotherapy (CT)] and the Delayed (25-120 hours) phase)
- Complete Control(During the Acute Phase (0-24 hours after chemotherapy), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle and separately on single days of all chemotherapy cycles (each cycle is 21 days), up to 4 cycles)
- Emesis-Free(During the Acute (0-24 hours after CT), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle (each cycle is 21 days)and separately on single days of all CT cycles,up to 4 cycles.Also during the period between two consecutive cycles)
- Nausea(During the Acute (0-24 hours after CT), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle (of 21 days)and separately on single days of all chemotherapy cycles, up to 4 cycles.Also during the period between two consecutive cycles)
- Global satisfaction with antiemetic therapy: Visual Analogue Scale (VAS)(During the Acute Phase (0-24 hours after CT), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle (each cycle is 21 days) and separately on single days of all CT cycles, up to 4 cycles)
- Safety profile (according to CTCAE)(During the Acute Phase (0-24 hours after CT), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle (each cycle is 21 days) and separately on single days of all CT cycles, up to 4 cycles)
研究者
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