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Chemotherapy-Induced Nausea and Vomiting (CINV) in breast cancer patients receiving a combination chemotherapy of doxorubicin or epirubicin with cyclophosphamide (AC-based regimen)MedDRA version: 20.0Level: LLTClassification code 10008443Term: Chemotherapy antiemetic prophylaxsisSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 21.1Level: PTClassification code 10054133Term: Prophylaxis of nausea and vomitingSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 21.1Level: LLTClassification code 10008448Term: Chemotherapy induced emesis prophylaxisSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 21.1Level: LLTClassification code 10049091Term: Chemotherapy antiemetic prophylaxisSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 21.1Level: LLTClassification code 10008449Term: Chemotherapy inducted emesis prophylaxisSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 21.1Level: LLTClassification code 10036899Term: Prophylaxis against chemotherapy induced vomitingSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Cancer [C04]
相关药物Akynzeo
概览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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.
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.
研究者
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