Phase II Study of Cardiac Safety and Tolerability of an Adjuvant Chemotherapy Plus Trastuzumab With Lapatinib in Patients With Resected HER2 + Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Number of Patients With Congestive Heart Failure (CHF) While on Active Treatment
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with trastuzumab and lapatinib after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This randomized phase II trial is studying the side effects and how well giving doxorubicin together with cyclophosphamide followed by trastuzumab, paclitaxel, and lapatinib works in treating patients with early-stage HER2-positive breast cancer that has been removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine the cardiac safety of adjuvant therapy comprising doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel, trastuzumab (Herceptin®), and lapatinib ditosylate in patients with resected early-stage HER2-positive breast cancer.
Secondary
- Determine the adverse event profile of this regimen in these patients.
- Determine the cumulative incidence of cardiac events in patients treated with this regimen.
- Determine the LVEF in patients treated with this regimen.
- Determine the disease-free and overall survival of patients treated with this regimen.
- Compare selected quality-of-life (QOL) questionnaires in these patients.
- Evaluate QOL of patients treated with this regimen.
- Determine the cumulative incidence of pulmonary events in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Patients With Congestive Heart Failure (CHF) While on Active Treatment
时间窗: 6 months
次要结局
- Number of Patients Who Experience >= 10 Percent Drop in Left Ventricular Ejection Fraction (LVEF)(5 years)
- Adverse Event Profile as Measured by NCI CTCAE v 3.0(5 years)
- Cumulative Incidence (CI) of Cardiac Events(5 years)
- Percentage of Participants With Disease-Free Survival (DFS)(5 years)
- Percentage of Participants With Overall Survival (OS)(5 years)
- Change in Overall LINEAR ANALOGUE SELF ASSESSMENT (LASA) and Change in Symptom Distress Scale (SDS) Overall QOL(5 years)
- Proportion of Patients Experienced a Significant Decline in LINEAR ANALOGUE SELF ASSESSMENT (LASA) and a Overall Symptom Distress Scale (SDS) QOL Measurements(5 years)
- Incidence of Pulmonary Events(5 years)