NCT00796978已完成2 期
Safety and Efficacy of Single Agent Adjuvant Trastuzumab (Herceptin®) in Older Women With Early-Stage and Locally Advanced Breast Cancer: A Phase II Trial
Cynthia Owusu, MD22 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2009年2月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 22
- 主要终点
- Percent of Participants Experiencing Cardiac Events at 1 Year
研究概览
简要总结
RATIONALE: 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.
PURPOSE: This phase II trial is studying the side effects of trastuzumab and to see how well it works in treating older women with early-stage breast cancer.
详细描述
OBJECTIVES:
Primary
- To evaluate the 3-year cumulative incidence of cardiac events in women 60 years and older with HER2-positive breast cancer who receive single agent trastuzumab (Herceptin®) in the adjuvant setting.
Secondary
- To evaluate the 1-year cumulative incidence of asymptomatic cardiac left ventricular dysfunction in women 60 years and older with Her2-positive breast cancer who receive single agent trastuzumab in the adjuvant setting.
- To evaluate long-term cardiac toxicity (5-year cumulative incidence of cardiac events) in women 60 years and older with Her2-positive breast cancer who receive single agent trastuzumab in the adjuvant setting.
- To assess the relation between physiologic markers of chronic heart failure and trastuzumab-related cardiac dysfunction in women 60 years and older with Her2-positive breast cancer who receive single agent trastuzumab.
- To assess the relation between pro-inflammatory cytokines and trastuzumab-related cardiac dysfunction in women 60 years and older with Her2-positive breast cancer.
- To determine the effect of this drug on the health-related quality of life and functional, cognitive, and mental status of women 60 years and older with Her2-positive breast cancer.
- To determine the 5-year disease-free survival and overall survival of women 60 years and older with Her2-positive breast cancer who receive single agent trastuzumab in the adjuvant setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the breast
- •Immunohistochemical staining for Her2 protein of 3+ intensity or Her2 gene amplification of ≥ 2.0 by FISH testing.
- •Life expectancy > 6 months
- •ECOG performance status ≤ 2
- •Node positive disease irrespective of tumor size
- •Node negative disease:
- •TNM Stage (AJCC Cancer Staging Manual 6th edition) T1b-T4, N0-3, M0, irrespective of hormonal status
- •Baseline LVEF ≥ lower limit of normal for a particular institution
- •Complete surgical removal of invasive cancer by mastectomy or lumpectomy
- •Complete staging work-up with CT of chest, abdomen, and pelvis plus bone scan or alternatively with PET scan for stage II and higher disease, or as determined by symptoms for all other stages. Additional staging work-up as per symptoms.
- •Adequate bone marrow function as indicated by the following:
- •ANC >1000/µL
- •Platelets ≥100,000/µL
- •Hemoglobin >10 g/dL
- •Adequate liver function, as indicated by bilirubin ≤1.5 x upper limit of normal (ULN) Adequate renal function, as indicated by creatinine ≤1.5 x ULN
- •AST or ALT <2 x ULN unless related to primary disease.
- •Signed informed consent
排除标准
- •Enrollment after more than 120 days from the last day of mastectomy or lumpectomy
- •Patients able to tolerate and willing to receive chemotherapy
- •Prior chemotherapy for current malignancy
- •Prior herceptin therapy
- •Active cardiac disease
- •Myocardial infarction (asymptomatic changes on EKG suggestive of old MI is not an exclusion)
- •Angina pectoris requiring anti-anginal treatment
- •Documented congestive heart failure (CHF)
- •Current use of any therapy specifically for CHF
- •Cardiac arrhythmia requiring medication
- •Current uncontrolled hypertension (diastolic >100 mmHg or systolic > 200 mmHg)
- •Clinically significant valvular abnormality (associated with New York Heart Association (NYHA) class II, III, or IV symptoms)
- •Clinically significant pericardial effusion (associated with New York Heart Association (NYHA) class II, III, or IV symptoms)
- •Past cardiac disease
- •Prior myocardial infarction (asymptomatic changes on EKG suggestive of old MI is not an exclusion)
- •Prior history of CHF
- •History of cardiomyopathy
- •Other diseases and conditions
- •Evidence of metastatic breast cancer (clinical or radiological evidence)
- •Active infection
- •Concomitant malignancies or previous malignancies within the last 3 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- •Hypersensitivity to trastuzumab
结局指标
主要结局
Percent of Participants Experiencing Cardiac Events at 1 Year
时间窗: At 1 year
Number of participants that experience cardiac events that include cardiac death due to congestive heart failure (CHF), Myocardial infarction (MI) or documented arrhythmia, death without definitive cause, or signs and symptoms of CHF as defined by New York Heart Association (NYHA) class III or IV symptoms.
次要结局
- Percent of Participants With Asymptomatic LV Cardiac Dysfunction at Five Years(At 5 years)
- Mean Change in Nutritional Status(From baseline to end-of-treatment (52 weeks))
- Overall Survival (OS) as Measured by Percent of Participants Alive at 2 Years(Up to 2 years)
- Mean Change in Cognitive Status(From baseline to end-of-treatment (52 weeks))
- Mean Change in Plasma Cardiac Markers(From baseline to end-of-treatment (52 weeks))
- Mean Change in Quality of Life From Baseline to End of Treatment(From baseline to end-of-treatment (52 weeks))
- Mean Change in Psychosocial Status (Depression)(From baseline to end-of-treatment (52 weeks))
- Percent of Participants Experiencing Cardiac Events at 3 Years(At 3 years)
- Percent of Participants Experiencing Cardiac Events at 5 Years(At 5 years)
- Percent of Participants of Asymptomatic Left Ventricular (LV) Cardiac Dysfunction at 1 Year(At 1 year)
- Percent of Participants With Asymptomatic LV Cardiac Dysfunction at Three Years(At 3 years)
- Percent of Participants With DFS(At 2 years)
- Overall Survival (OS) as Measured by Percent of Participants Alive at 1 Year(Up to 1 years)
- Overall Survival (OS) as Measured by Percent of Participants Alive at 3 Years(Up to 3 years)
- Overall Survival (OS) as Measured by Percent of Participants Alive at 5 Years(Up to 5 years)
- Mean Change in Pro-inflammatory Cytokines(From baseline to end-of-treatment (52 weeks))
- Percent of Participants With Disease-free Survival (DFS)(At 5 years)
- Mean Change in Quality of Life From Baseline to Mid-treatment(From Baseline to mid-treatment (week 26))
- Mean Change in Functional Status(baseline to end-of-treatment (52 weeks))
- Mean Change in Psychosocial Status (Social Support)(From baseline to end-of-treatment (52 weeks))
研究者
Cynthia Owusu, MD
Principal Investigator
Case Comprehensive Cancer Center
研究点 (22)
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