EUCTR2017-001094-16-GB进行中（未招募）1 期
Preventing cardiac damage in patients treated for breast cancer and lymphoma: a phase 3Randomised, Open label, blinded endpoint, trial of enalapril to preventAnthracycline-induced CardioToxicity (PROACT). - Preventing Cardiotoxicity in Patients with Breast Cancer: PROACT
South Tees NHS Foundation Trust0 个研究点目标入组 170 人开始时间: 2017年5月10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
- 入组人数
- 170
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
- All
入选标准
- •Adult patients with histopathologically* confirmed breast carcinoma who have received surgery for their breast cancer;
- •Planned to receive 6 cycles of EC 90 (total planned dose 540 mg/m2 epirubicin) or FEC 75 (total planned dose 450 mg/m2 epirubicin) adjuvant chemotherapy regimen;
- •Adult patients with histopathologically confirmed non-Hodgkin lymphoma planned to receive 6 cycles of R-CHOP or CHOP (total planned dose 300mg/m2 doxorubicin) chemotherapy
- •Written informed consent.
- •*Patients with HER2+ breast cancer are eligible for inclusion.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 85
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 85
排除标准
- •Positive baseline cardiac troponin T (=14ng/L);
- •known contraindication to ACE inhibitor e.g. renal artery stenosis, severe aortic stenosis;
- •are taking, or have a previous intolerance to ACEI (e.g. angioedema);
- •patient already taking other agents acting on the renin-angiotensin-aldosterone system e.g. Aliskiren, angiotensin receptor blockers (ARBs), Entresto (sacubitril/valsartan), spironolactone, eplerenone;
- •LVEF <50%*;
- •estimated GFR < 30 mL/min/1.73m2 at baseline;
- •hyperkalaemia defined as serum potassium =5.5mmol/L;
- •symptomatic hypotension, or Systolic Blood Pressure <100mmHg;
- •poorly-controlled hypertension (Blood Pressure >160/100mmHg**, or ambulatory BP of 150/95mmHg);
- •previous myocardial infarction;
- •known metastatic breast cancer;
- •previous exposure to anthracycline chemotherapy;
- •are pregnant or breastfeeding;
- •previous Herceptin treatment or planned Herceptin treatment within four weeks following anthracycline chemotherapy;
- •for patients of childbearing potential: refusal to use adequate contraception throughout the trial;***
- •any other invasive cancer diagnosed and treated in the past 5 years;
- •symptomatic or severe asymptomatic radiation-induced cardiac disease;
- •participation in other interventional medicinal trials in the past 6 months;
- •judgement by the investigator that the patient has a prognosis of < 1 year or are unlikely to complete 6 cycles of chemotherapy.
- •judgement by the investigator that the patient is high risk for tumour lysis syndrome (applicable only to NHL patients).
- •judgement by the Investigator that the patient should not participate in the study, for example, if the patient is unlikely to comply with study procedures, restrictions, and requirements.
- •*<50% as defined by Simpson’s biplane method; if absolute measurements are not possible, then a visually normal assessment of LVEF is acceptable for inclusion.
- •**White coat hypertension is more common, and should be ruled out by an ambulatory blood pressure monitor
- •***Female patients between the ages of 18 and 50 will receive a pregnancy test at baseline.
- •Adequate methods of contraception are those that can achieve a failure rate of less than 1% per year when used consistently and correctly, such methods include:
- •combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
- •ointravaginal
- •otransdermal
- •progestogen-only hormonal contraception associated with inhibition of ovulation
- •oinjectable
- •oimplantable
- •intrauterine device (IUD)
- •intrauterine hormone-releasing system (IUS)
- •bilateral tubal occlusion
- •vasectomy/vasectomised partner
- •true sexual abstinence (refraining from heterosexual intercourse during the entire period of study treatment)
研究者
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