Randomized Phase II Trial Of Interventional Therapy Investigate Cardiac Protection of Dexrazoxane In Women With Breast Cancer Having Experienced Grade 1 Cardiotoxicity During Prior Anthracycline-based Chemotherapy.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Occurence of cardiac toxicity in patients with breast cancer receiving anthracycline chemotherapy
研究概览
简要总结
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. CTnT/cTnI/ANP/BNP were proved to be used as a biomarker of drug related cardiotoxicity. There are excellent correlations between the total cumulative dose of doxorubicin, the severity of the resulting cardiomyopathy, and the level of serum troponin-T.
详细描述
Patients with breast cancer receiving anthracycline chemotherapy randomized to 3 groups:chemotherapy plus low dose dexrazoxane,chemotherapy plus middle dose dexrazoxane, chemotherapy only.Every patient receive at least 2 cycles anthracycline chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed primary infiltrating adenocarcinoma of the breast
- •Confirmed by core needle biopsy or incisional biopsy or surgery
- •Experienced grade 1 cardiac toxicity during prior anthracycline-based chemotherapy
- •At least 2 cycles same anthracycline based chemotherapy are needed
排除标准
- •Accumulated dose of EPI ≥1000mg/m2,ADM≥550mg/m2
- •With the following risk factors: Uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension); Prior or Concurrent radiation to heart
- •Pregnant or nursing
- •Other currently active malignancy except nonmelanoma skin cancer
- •Uncontrolled or severe bleeding,diarrhea,intestinal obstruction
- •Grade 2 or more Cardiac Toxicity (CTC AE3.0)
研究组 & 干预措施
low dose dexrazoxane group
anthracycline chemotherapy plus low dose dexrazoxane(10:1)
干预措施: Dexrazoxane hydrochloride (Drug)
middle dose dexrazoxane group
anthracycline chemotherapy plus middle dose dexrazoxane(15:1)
干预措施: Dexrazoxane hydrochloride (Drug)
结局指标
主要结局
Occurence of cardiac toxicity in patients with breast cancer receiving anthracycline chemotherapy
时间窗: 1 year
次要结局
- Relationship between serum level of cTnT/cTnI/ANP/BNP and cardiac toxicity(1 year)