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Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer

2013年7月18日 更新者：UNICANCER

Randomized And Multicentric Opened Phase III Study Evaluating The Concomitant Administration Of Docetaxel 75MG/M2 and Epirubicine 75MG/M2 Versus FEC 100 In Non Metastatic With Positive Lymphatic Nodes Breast Cancer Subjects, And The Sequential Addition Of Herceptin In (HER2+++) And (HER2++ And FISH+) Subjects

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of chemotherapy plus radiation therapy with or without trastuzumab is more effective in treating breast cancer.

PURPOSE: Randomized phase III trial to compare two different chemotherapy regimens plus radiation therapy with or without trastuzumab in treating women who have breast cancer that has spread to lymph nodes in the axilla (under the arm).

研究概览

地位

完全的

条件

干预/治疗

详细说明

OBJECTIVES:

  • Compare the efficacy of adjuvant cyclophosphamide, epirubicin, and fluorouracil vs adjuvant docetaxel and epirubicin, in terms of 5-year survival without relapse, in women with nonmetastatic adenocarcinoma of the breast with lymph node invasion.
  • Determine survival of patients treated with these regimens.
  • Compare the tolerability of trastuzumab (Herceptin) in patients treated with these regimens.
  • Determine the efficacy and tolerability of trastuzumab in patients with hormone receptor-positive tumors.
  • Evaluate the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center. Patients are treated in 2 parts.

  • Part I: Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive fluorouracil IV, or epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy 5 days a week for 5 weeks.
    • Arm II: Patients receive epirubicin IV over 10 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy as in arm I.

Patients with HER2/neu-positive tumors then proceed to part II. Patients with HER2/neu-negative tumors receive no further treatment.

Patients with hormone (estrogen or progesterone) receptor-positive tumors also receive oral tamoxifen daily beginning after chemotherapy is completed and continuing for 5 years.

  • Part II: Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes every 3 weeks for 1 year.
    • Arm II: Patients are followed without treatment. Patients not receiving trastuzumab are followed at 4 months, 6 months, every 4 months for 1 year, and then every 6 months for 3 years. Patients receiving trastuzumab are followed at 4 months and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 2,600 patients will be accrued for this study within 3 years.

研究类型

介入性

注册 (实际的)

3010

阶段

  • 第三阶段

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

  • 法国
      • Angers、法国、49036
        • Centre Paul Papin
      • Annecy、法国、74011 Cedex
        • Centre hospitalier d'Annecy
      • Bordeaux、法国、33076
        • Institut Bergonie
      • Bourg En Bresse、法国、01012
        • C.H. Bourg En Bresse
      • Caen、法国、14076
        • Centre Regional Francois Baclesse
      • Clermont-Ferrand、法国、63011
        • Centre Jean Perrin
      • Creteil、法国、94010
        • Hôpital Intercommunal de Créteil
      • Dijon、法国、21079
        • Centre de Lutte Contre le Cancer Georges-Francois Leclerc
      • Grenoble、法国、38100
        • Institut Prive de Cancerologie
      • Harfleur、法国、76700
        • Clinique du Petit Colmouilins
      • Lagny Sur Marne、法国、77405
        • Centre Hospitalier de Lagny
      • Le Chesnay、法国、78157
        • Hôpital André Mignot
      • Le Havre、法国、76600
        • CMC Les Ormeaux
      • Marseille、法国、13273
        • Institut J. Paoli and I. Calmettes
      • Metz、法国、57038
        • Centre Hospitalier Régional Metz Thionville
      • Montbeliard、法国、25209
        • Centre Hospitalier General Andre Boulloche
      • Montpellier、法国、34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
      • Mulhouse、法国、68051
        • Centre Hospitalier de Mulhouse
      • Nantes-Saint Herblain、法国、44805
        • Centre Regional Rene Gauducheau
      • Paris、法国、75674
        • Hopital Avicenne
      • Perpignan、法国
        • Clinique Saint - Pierre
      • Poitiers、法国、86021
        • CHU Poitiers
      • Reims、法国、51056
        • Institut Jean Godinot
      • Rennes、法国、35042
        • Centre Eugene Marquis
      • Sainte Clotilde、法国、97492
        • Clinique sainte Clotilde
      • Strasbourg、法国、67065
        • Centre Paul Strauss
      • Strasbourg、法国、67091
        • Hopitaux Universitaire de Strasbourg
      • Toulouse、法国、31052
        • Institut Claudius Regaud
      • Villejuif、法国、F-94805
        • Institut Gustave Roussy

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 至 64年 (成人)

接受健康志愿者

不

有资格学习的性别

女性

描述

DISEASE CHARACTERISTICS:

  • Histologically confirmed nonmetastatic, unilateral adenocarcinoma of the breast

    • Axillary lymph node invasion (N1, N2, or N3)
    • No cutaneous invasion
    • No T4a or greater disease
  • No clinically or radiologically suspected metastases
  • No clinically or radiologically suspected contralateral lesion
  • No deeply adherent or inflammatory disease
  • Complete surgical resection performed, including removal of at least 5 lymph nodes, and with no residual tumor, within the past 42 days
  • No prior breast cancer

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 to 64

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • WHO 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • ALT and AST no greater than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN
  • Bilirubin no greater than ULN
  • Hepatitis B and hepatitis C negative
  • No hepatic dysfunction

Renal

  • Creatinine less than 1.3 mg/dL OR
  • Creatinine clearance greater than 60 mL/min

Cardiovascular

  • ECHO normal
  • LVEF at least 50%

Pulmonary

  • FEV normal
  • No dyspnea at rest
  • No supplemental oxygen dependence

Other

  • Not pregnant
  • Fertile patients must use effective contraception
  • HIV negative
  • No active infection
  • No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • No contraindication to anthracycline therapy
  • No chronic medical or psychological condition
  • No geographic or social reason that would preclude study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 4 weeks since prior chemotherapy
  • No other concurrent chemotherapy
  • No contraindication to anthracycline therapy

Endocrine therapy

  • No prior hormonal therapy

Radiotherapy

  • No prior radiotherapy

Surgery

  • See Disease Characteristics

Other

  • At least 4 weeks since prior experimental therapy

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
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：6 FEC
Patients receive fluorouracil IV, or epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy 5 days a week for 5 weeks.
生物：Trastuzumab
8 mg/kg at month M6, followed by a maintenance dose of 6 mg/kg every 3 weeks for a 1 year (i.e. 18 injections in total)
其他名称：
  • 赫赛汀
药品：Cyclophosphamide
500 mg/m², D1 and every 3 weeks
药品：Epirubicin
100 mg/m², D1 and every 3 weeks
其他名称：
  • 盐酸表柔比星
药品：Fluorouracil
500 mg/m², D1 and every 3 weeks
实验性的：6 DE
Patients receive epirubicin IV over 10 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy as in arm I
生物：Trastuzumab
8 mg/kg at month M6, followed by a maintenance dose of 6 mg/kg every 3 weeks for a 1 year (i.e. 18 injections in total)
其他名称：
  • 赫赛汀
药品：Epirubicin
100 mg/m², D1 and every 3 weeks
其他名称：
  • 盐酸表柔比星
药品：docetaxel
on day D1 of each cycle : dose: 75 mg/m², route: i.v. injection over 1 hour, every 3 weeks

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Progression Free Survival
大体时间：5 years from randomization
5 years from randomization

次要结果测量

结果测量
大体时间
Herceptin safety
大体时间：5 years from randomization
5 years from randomization
Overall survival
大体时间：5 years from randomization
5 years from randomization

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。

赞助

UNICANCER

调查人员

  • 学习椅：Marc Spielmann, MD、Gustave Roussy, Cancer Campus, Grand Paris

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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

2001年6月1日

初级完成 (实际的)

2009年6月1日

研究完成 (实际的)

2009年12月1日

研究注册日期

首次提交

2003年2月5日

首先提交符合 QC 标准的

2003年2月5日

首次发布 (估计)

2003年2月6日

研究记录更新

最后更新发布 (估计)

2013年7月19日

上次提交的符合 QC 标准的更新

2013年7月18日

最后验证

2013年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • UC-0140/0005 - PACS 04
  • FRE-FNCLCC-PACS-04/0005
  • EU-20236
  • PACS04 (其他标识符：UNICANCER)

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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