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Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast Cancer

2012年8月10日 更新者:Ingrid Mayer, MD、Vanderbilt-Ingram Cancer Center

A Multi-Institutional Phase II Pilot Trial With Weekly Docetaxel and Herceptin as First or Second Line Therapy for HER2/Neu Overexpressing Metastatic Breast Cancer

RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of trastuzumab plus docetaxel in treating women who have recurrent or metastatic breast cancer.

研究概览

详细说明

OBJECTIVES: I. Determine the objective response rate of women with HER2-neu overexpressing recurrent or metastatic breast cancer treated with trastuzumab (Herceptin) in combination with docetaxel. II. Determine the toxicity of this treatment regimen in these patients. III. Determine the duration of response to this treatment regimen in these patients. IV. Determine the time to progression in these patients after receiving this treatment regimen. V. Compare HER2-neu overexpression as determined by fluorescent in situ hybridization (FISH) versus immunohistochemistry, and correlate these findings with response to this treatment regimen in these patients. VI. Correlate HER2-neu activation by immunohistochemistry and the extracellular domain of HER2-neu by ELISA with response to this treatment regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 30 minutes weekly for 6 weeks plus trastuzumab (Herceptin) IV over 30-90 minutes weekly for 8 weeks. Treatment continues every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 3 months, every 3 months for 9 months, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 18-34 patients will be accrued for this study.

研究类型

介入性

注册 (实际的)

46

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Alabama
      • Mobile、Alabama、美国、36608
        • Providence Hospital
    • Illinois
      • Chicago、Illinois、美国、60611-3013
        • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
      • Evanston、Illinois、美国、60201
        • Evanston Hospital
    • Kentucky
      • Owensboro、Kentucky、美国、42303
        • Owensboro Medical Health System
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19111
        • Fox Chase Cancer Center
    • Tennessee
      • Chattanooga、Tennessee、美国、37403
        • Erlanger Health Systems
      • Chattanooga、Tennessee、美国、37404
        • Memorial Health Care System
      • Franklin、Tennessee、美国、37067
        • Williamson Medical Center
      • Jackson、Tennessee、美国、38301
        • Jackson-Madison County Hospital
      • Knoxville、Tennessee、美国、37916
        • Methodist/Thompson Oncology Research
      • Knoxville、Tennessee、美国、37920
        • Tennessee Cancer Specialists
      • Memphis、Tennessee、美国、38104
        • Boston Baskin Cancer Group
      • Nashville、Tennessee、美国、37232-6838
        • Vanderbilt-Ingram Cancer Center
      • Nashville、Tennessee、美国、37205
        • St. Thomas Health Services
      • Oak Ridge、Tennessee、美国、37831
        • Methodist Medical Center of Oak Ridge

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

女性

描述

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or metastatic breast cancer HER2-neu overexpressing tumor (2+ or 3+) Measurable or evaluable disease If bone disease only, must have lytic lesions No carcinomatous meningitis or untreated or uncontrolled brain parenchymal disease Prior brain parenchymal disease allowed if controlled by appropriate therapy given at least 8 weeks prior to study, and patient is asymptomatic from CNS disease Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal Alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN) SGOT and SGPT no greater than 1.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No congestive heart failure Ejection fraction greater than 45% by MUGA No myocardial infarction within the past 6 months No ischemic heart disease requiring medication No uncontrolled hypertension Other: No peripheral neuropathy grade 2 or more No other prior malignancy within the past 5 years except curatively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or contralateral breast cancer No active unresolved infection No history of hypersensitivity reaction to products containing Polysorbate 80 No poorly controlled diabetes mellitus Not pregnant Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic response modifiers Chemotherapy: Prior adjuvant chemotherapy allowed No more than 1 prior chemotherapy regimen for metastatic disease No prior taxane (docetaxel or paclitaxel) Prior doxorubicin allowed if total dose less than 250 mg/m2 No other concurrent chemotherapy Endocrine therapy: Prior hormonal therapy allowed No concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy No prior cumulative radiotherapy to more than 25% of bone marrow No concurrent radiotherapy Surgery: Not specified Other: At least 7 days since prior antibiotics No other concurrent investigational drugs No other concurrent antineoplastic therapy No concurrent parenteral antibiotics

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

1998年9月1日

初级完成 (实际的)

2003年7月1日

研究完成 (实际的)

2003年7月1日

研究注册日期

首次提交

2000年8月3日

首先提交符合 QC 标准的

2003年12月23日

首次发布 (估计)

2003年12月24日

研究记录更新

最后更新发布 (估计)

2012年8月14日

上次提交的符合 QC 标准的更新

2012年8月10日

最后验证

2012年8月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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