EUCTR2015-003316-20-IT进行中（未招募）1 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 a combination chemotherapy of doxorubicin or epirubicin with cyclophosphamide (AC-based regimen) - NEPA to prevent chemotherapy induced nausea and vomiting in patients with breast cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •–Women >= 18 years old.
- •–Histologically or cytologically confirmed diagnosis of breast cancer.
- •–Na¿f patients.
- •–Be scheduled to receive adjuvant chemotherapy with anthracycline (doxorubicin or epirubicin) + cyclofosfamide (AC-based regimen).
- •–ECOG 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.
- •–Normal 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 135
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •–Advanced/metastatic breast cancer.
- •–Patients already submitted to non-AC-based chemotherapy.
- •–Treatment with investigational medications within 30 days before NEPA.
- •–Myocardial infarction within the last 6 months.
- •–Documented or known hypersensitivity to 5HT3RA or NK1RA 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 disorders interfering with ability to comply with study protocol.
研究者
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