EUCTR2012-005352-41-IT进行中（未招募）1 期
A phase II randomized, open-label study evaluating the addition of trastuzumab to (nabTM)-paclitaxel as first line treatment in primary HER2 negative metastatic breast cancer patients with HER2 positive Circulating Tumor Cells (CTCs). - Trastuzumab and (nabTM)-paclitaxel as first line MBC in HER2+ve CTC with primary HER2-ve.
AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI CREMONA0 个研究点目标入组 86 人开始时间: 2014年3月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 86
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
- •1.Signed written informed consent.
- •2.Age =18 years.
- •3.ECOG 0-2
- •4.At least one clinically or radiologically measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria In Solid Tumors (RECIST version 1.1). Osteoblastic/osteolytic bone metastasis will be included.
- •5.HER2 negative on primary tumor (HER-2 score of 0 or 1+/2+ with FISH not amplified) as locally diagnosed.
- •6.Detection of at least 1 HER2+ve CTC.
- •7.Patients may have received chemotherapy/hormonotherapy as neo/adjuvant treatment.
- •8.Adequate bone marrow, renal and hepatic functions: ANC greater than 1.5x10^9/l, platelets greater than 100x10^9/l, serum creatinine < 1.5 x UNL, serum AST/ALT < 1.5 x UNL unless liver metastasis < 2.5 x UNL.
- •9.Adequate cardiac function: left ventricular ejection fraction (LVEF) at rest measured by echocardiography or MUGA scan must be no lower than the local normal limit.
- •10.Troponin level below the cut-off.
- •11.Absence of clinically significant cardiovascular disease (e.g. myocardial infarction, unstable angina), New York Hearth Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or grade II or greater peripheral vascular disease within 12 months prior to day 1 on study.
- •12.Geographically accessible for follow-up.
- •13.Pregnancy test negative.
- •14.For women of childbearing potential who are sexually active, agreement to use a highly effective, non-hormonal form of contraception or two effective forms of non-hormonal contraception during and for at least 6 months post-study treatment.
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1.Previous chemotherapy or hormonotherapy for metastatic disease
- •2.Any psychiatric disorder that would impair the understanding and giving of informed consent.
- •3.Male patients
- •4.Non evaluable lesions as ascitic, pleural and pericardial effusions, carcinomatous lymphangitis of the lung, meningeal involvement.
- •5.Pregnant or lactating patients.
- •6.History of atrial ventricular arrhythmia, congestive heart failure or angina pectoris, even if medically controlled; uncontrolled hypertension; history of 2nd or 3rd degree heart blocks.
- •7.Any history of a second neoplasm except for curatively treated non melanoma skin cancer or carcinoma in situ of the cervix.
- •8.Concomitant treatment with other anticancer drugs.
- •9.Concomitant treatment with any other experimental drug.
- •10.Patients with not adequate haematological, hepatic and renal function.
- •11.Current known infection with HIV, HBV or HCV.
- •12.Any other serious illness or medical condition.
研究者
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