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

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ClinicalTrials.gov Identifier: NCT00054587
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : July 19, 2013
Sponsor:
Information provided by (Responsible Party):
UNICANCER

Tracking Information
First Submitted Date  ICMJE February 5, 2003
First Posted Date  ICMJE February 6, 2003
Last Update Posted Date July 19, 2013
Study Start Date  ICMJE June 2001
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2013)
Progression Free Survival [ Time Frame: 5 years from randomization ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00054587 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2013)
  • Herceptin safety [ Time Frame: 5 years from randomization ]
  • Overall survival [ Time Frame: 5 years from randomization ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
Official Title  ICMJE 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
Brief Summary

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).

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Biological: 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)
    Other Name: Herceptin
  • Drug: Cyclophosphamide
    500 mg/m², D1 and every 3 weeks
  • Drug: docetaxel
    on day D1 of each cycle : dose: 75 mg/m², route: i.v. injection over 1 hour, every 3 weeks
  • Drug: Epirubicin
    100 mg/m², D1 and every 3 weeks
    Other Name: epirubicin hydrochloride
  • Drug: Fluorouracil
    500 mg/m², D1 and every 3 weeks
Study Arms  ICMJE
  • Active Comparator: 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.
    Interventions:
    • Biological: Trastuzumab
    • Drug: Cyclophosphamide
    • Drug: Epirubicin
    • Drug: Fluorouracil
  • Experimental: 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
    Interventions:
    • Biological: Trastuzumab
    • Drug: docetaxel
    • Drug: Epirubicin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2013)
3010
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00054587
Other Study ID Numbers  ICMJE UC-0140/0005 - PACS 04
FRE-FNCLCC-PACS-04/0005
EU-20236
PACS04 ( Other Identifier: UNICANCER )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UNICANCER
Study Sponsor  ICMJE UNICANCER
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Marc Spielmann, MD Gustave Roussy, Cancer Campus, Grand Paris
PRS Account UNICANCER
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP