EUCTR2013-001226-25-IT进行中（未招募）1 期
A phase II randomized, open-label neo-adjuvant study of standard chemotherapy regimen compared to high dose chemotherapy regimen with autologous stem cell transplantation in patients with triple negative breast cancer - HDC with AHST in triple negative breast cancer
ISTITUTI OSPITALIERI DI CREMONA0 个研究点开始时间: 2014年12月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •For inclusion in the study, patients must fulfil all of the following criteria:
- •Age =18 years < 60 yrs
- •ECOG/SAKK Performance Status 0-1
- •Clinically or radiologically measurable or evaluable disease defined as: presence of bidimensionally or unidimensionally measurable breast lesion (T > 2,5, Any N) by physical or radiological examination.
- •Estrogen receptor < 10%
- •Progesteron recptor = 0
- •HER2 negative on primary tumor (HER-2 score of 0 or 1+/2+ with FISH not amplified)
- •Adequate bone marrow, renal and hepatic functions: ANC greater than 1.5x109/l, platelets greater than 100x109/l, serum creatinine < 1.5 x UNL, serum AST/ALT < 1.5 x UNL unless liver metastasis < 2.5 x UNL.
- •Adequate cardiac function: left ventricular ejection fraction (LVEF) at rest measured by echocardiography must be no lower than the local normal limit.
- •Troponin level below the cut-off
- •Absence of clinically significant cardiovascular disease (e.g. myocardial infarction, unstable angina), New York Hearth Association (NYHA) grade II or greater congestive hearth failure, serious cardiac arrhythmia requiring medication, or grade II or greater peripheral vascular disease within 12 months prior to day 1 on study
- •Written informed consent dated and signed by both patients and investigator
- •Geographically accessible for follow-up
- •Pregnancy test negative
- •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 74
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •IIIB IIIC IV Stage e inflammatory breast cancer
- •Previous chemotherapy for early breast cancer
- •Any psychiatric disorder that would impair the understanding and giving of informed consent.
- •Male patients
- •Non clinical and radiological evaluable breast lesion
- •Pregnant or lactating patients.
- •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.
- •Any history of a second neoplasm except for curatively treated non melanoma skin cancer or carcinoma in situ of the cervix.
- •Concomitant treatment with other anticancer drugs.
- •Concomitant treatment with any other experimental drug.
- •Patients with not adequate haematological, hepatic and renal function
- •Any other serious illness or medical condition
研究者
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