NCT00381901已完成3 期
Protocol of Herceptin Adjuvant With Reduced Exposure, a Randomised Comparison of 6 Months vs 12 Months in All Women Receiving Adjuvant Herceptin [PHARE]
National Cancer Institute, France161 个研究点 分布在 1 个国家目标入组 3,400 人开始时间: 2006年5月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,400
- 试验地点
- 161
- 主要终点
- Time to recurrence
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. It is not yet known whether giving trastuzumab for 6 months is as effective as giving trastuzumab for 1 year in treating patients with breast cancer.
PURPOSE: This randomized phase III trial is studying trastuzumab to see how well it works when given for 6 months compared to 12 months in treating women with nonmetastatic breast cancer that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Compare the disease-free survival of women with nonmetastatic, resectable breast cancer treated with adjuvant trastuzumab (Herceptin®) for 6 months vs 12 months.
Secondary
- Compare cardiotoxicity in patients receiving these regimens.
- Compare the cardiotoxicity and disease-free survival of patients receiving concurrent trastuzumab and chemotherapy vs sequential administration.
- Correlate HER-2 polymorphism with disease-free survival/cardiotoxicity in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the breast
- •Nonmetastatic disease
- •Positive or negative axillary nodes
- •Tumor size ≥ 10 mm
- •Resectable disease
- •Must have received ≥ 4 courses of chemotherapy for this disease
- •A 12-month adjuvant treatment with trastuzumab (Herceptin®) has been initiated
- •Informed consent form must be signed between the third and sixth months of trastuzumab therapy
- •Overexpression of HER-2 in the invasive component of the primary tumor as indicated by 1 of the following:
- •3+ by immunohistochemistry (IHC)
- •2+ by IHC and confirmation by fluorescent in situ hybridization (FISH) or chromogenic in situ hybridization (CISH)
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status not specified
- •LVEF considered favorable for continuing trastuzumab treatment as measured by echocardiography or MUGA at 2-4 months after beginning adjuvant trastuzumab
- •No serious cardiac illness or medical condition precluding trastuzumab treatment, including any of the following:
- •History of documented congestive heart failure
- •High-risk uncontrolled arrhythmias
- •Angina pectoris requiring antianginal medication
- •Severe dyspnea at rest or oxygen-dependent
- •No known hypersensitivity to trastuzumab, murine proteins, or any of the excipients
- •Not pregnant or nursing
- •No social, geographical, or psychological condition that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Other prior anti-HER-2 therapy allowed
- •No prior trastuzumab other than initiation of trastuzumab adjuvant therapy
排除标准
- 未提供
结局指标
主要结局
Time to recurrence
次要结局
- Distant metastasis-free survival
- Cardiotoxicity as measured by LVEF
- Overall survival
研究者
研究点 (161)
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