EUCTR2016-002270-12-IT进行中（未招募）1 期
Clinical trial phase II, prospective, open, randomized, controlled study to evaluate the preventive effect of trimetazidine on the cardiotoxicity of trastuzumab and chemotherapy in patients with breast cancer HER2 + - TRIMETA
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
- 242
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
- •patients of adult women (> 18 years <60 years) with a histological diagnosis of breast cancer with positive HER2 receptor, already undergone breast imaging intervention, which were seeking to receive a chemotherapy treatment with anthracyclines, taxanes and trastuzumab.
- •Preserved ejection fraction (EF =55%)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 (Appendix 1)
- •Life expectancy greater than 5 years
- •signing an informed consent of the patient who will be given a copy
- •availability to follow up
- •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 242
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Metastatic disease
- •Deficit of bone marrow function as assessed by the absolute neutrophil count (ANC) <= 1000 / mm3, hemoglobin <= 9 g / dL, and platelet count <= 100,000 / mm3.
- •hepatic dysfunction defined as total bilirubin> 1.5 mg / dl and alkaline phosphatase, SGOT and SGPT> 2.5 times normal
- •Previous malignancies undergoing chemotherapy or radiotherapy treatment, other concomitant neoplasms and any underlying medical condition that could make it dangerous to administration of the study drug or obscure the interpretation of results and adverse events
- •ischemic heart disease diagnosis based on clinical or instrumental (ECG, of inducible myocardial ischemia testing, coronary angiography); previous myocardial infarction; valve disease (stenosis and / or aortic insufficiency or mitral) more severe than mild; congestive heart failure
- •Non sinus rhythm and / or presence of left bundle branch block on electrocardiogram
- •Pacemakers
- •Global longitudinal strain <-19%
- •Concomitant treatment with cardiac drugs (nitrates, beta-blockers, ACE inhibitors, angiotensin receptor blockers and diuretics) or cardioprotective drugs (dexrazoxane).
- •History of allergic reactions and / or hypersensitivity to anthracyclines, taxanes, trastuzumab and / or trimetazidine.
- •Pregnancy confirmed by pregnancy test at enrollment. Women who refuse to use for the entire duration of the study an effective contraceptive method. Effective contraception means: double barrier methods [more spermicidal condoms in combination with diaphragm, cervical cap, or intrauterine device (IUD)], total abstinence from (IUD)], total abstinence from sexual intercourse or relations with vasectomized partners. Partial withdrawal is not accepted. Partial withdrawal is not accepted. Patients and / or the partners who are surgically sterile or postmenopausal are exempt from this requirement.
- •Breast-feeding
- •arterial hypertension grade II and higher (according to ESC 2013 guidelines) with systolic blood pressure (SBP)> = 160 mmHg and / or diastolic blood pressure (DBP)> = 100 mmHg
- •kidney failure superior to moderate (creatinine clearance <60 ml / min calculated according to the Cockcroft Gault - Appendix 2)
- •neurological comorbidities: Parkinson's disease, parkinsonian symptoms, restless legs syndrome and movement disorders
- •history of substance abuse (alcohol, drugs and / or psychotropic substances) or psychiatric conditions that could limit the ability of the patient to comply with the study or to follow up compliance procedures.
研究者
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