Cardiotoxicity of Targeted Therapy for HER-2 Positive Breast Cancer Patients at High altitude-a Multicenter, Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Incidence rate of cardiotoxicity
研究概览
简要总结
This is a prospective, multicenter, cohort study aiming to explore the cardiotoxicity of targeted therapy for HER-2 positive breast cancer patients who lives in high altitude area. One hundred and thirty two HER-2 positive breast cancer patients who will receive neoadjuvant, adjuvant, or palliative targeted therapy will be enrolled. The cardiotoxicity of targeted therapy will be observed and recorded during the treatment and one year after the end of treatment. The subjects will be stratified by age, baseline cardiac risk factors, and anthracyclines.
详细描述
HER-2 positive breast cancer patients who live at high altitudes greater than 2000 meters for long periods of time and will receive trastuzumab-based targeted therapy will be enrolled. The subjects included early and advanced patients. Treatment regimens includes chemotherapy combined with trastuzumab, chemotherapy combined with trastuzumab and pertuzumab, trastuzumab alone, and trastuzumab plus pertuzumab. Electrocardiogram, cardiac ultrasound, NT-proBNP, and TNI will be tested every 3 months when the treatment begins. The primary endpoint is cardiotoxity. The second endpoints is pathologic complete response (pCR) rate in neoadjuvant therapy, objective remission rate (ORR) and disease control rate (DCR) in neoadjuvant and palliative therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed invasive HER2-positive breast cancer.
- •The baseline left ventricular ejection fraction >55%.
- •Living at high altitude area （>2000 meters）for at least 10 years.
- •ECOG score 0-
- •Expected survival time ≥ 12 months.
排除标准
- •Patients with previous breast cancer or other malignant tumor within 5 years.
- •Patients who had accepted previous anti-HER2 or anthracyclines-based therapy.
- •Patients with severe heart disease or discomfort.
- •Patients who are pregnant.
- •Patients with other conditions considered not suitable to be enrolled by the investigator.
结局指标
主要结局
Incidence rate of cardiotoxicity
时间窗: 5 years
Cardiotoxicity includes death from cardiac cause, severe congestive heart failure (New York Heart Association Class III or IV), more than 10% decrease of left ventricular ejection fraction (LVEF) and to below 50%, and an asymptomatic or mildly symptomatic (NYHA class II) substantial decrease in LVEF.
次要结局
- the incidence of treatment-related adverse events(5 years)
- DCR(4 years)
- pCR rate(4 years)
- ORR(4 years)
- OS(5 years)
研究者
Jiuda Zhao
Professor
Affiliated Hospital of Qinghai University