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Combination Chemotherapy in Treating Women With Resected Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00033683
Recruitment Status : Unknown
Verified June 2005 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : February 9, 2009
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE April 9, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date February 9, 2009
Study Start Date  ICMJE February 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
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 in Treating Women With Resected Breast Cancer
Official Title  ICMJE A Randomised Trial Of Standard Anthracycline-Based Chemotherapy With Fluorouracil, Epirubicin And Cyclophosphamide (FEC) Or Epirubicin And CMF (Epi-CMF) Versus FEC Followed By Sequential Docetaxel As Adjuvant Treatment For Women With Early Breast Cancer
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any tumor cells remaining after surgery. It is not yet known which combination chemotherapy regimen is more effective in treating resected stage I or stage II breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating women who have resected stage I or stage II breast cancer.

Detailed Description


  • Compare the disease-free and overall survival of women with completely resected stage I or II breast cancer adjuvantly treated with fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin followed by cyclophosphamide, methotrexate, and fluorouracil (EPI-CMF) versus FEC followed by sequential docetaxel.
  • Compare the acute toxicity of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, estrogen receptor status (positive vs negative), and nodal status. Within 8 weeks after definitive surgery, patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients are assigned to 1 of 2 standard adjuvant chemotherapy regimens.

    • Regimen A: Patients receive fluorouracil, epirubicin, and cyclophosphamide (FEC) IV on day 1. Treatment repeats every 3 weeks for 8 courses.
    • Regimen B: Patients receive epirubicin IV on day 1. Treatment repeats every 3 weeks for 4 courses. Patients then receive cyclophosphamide orally on days 1-14 or IV on days 1 and 8 and methotrexate IV and fluorouracil IV on days 1 and 8 (CMF). Treatment with CMF repeats every 4 weeks for 4 courses.
  • Arm II: Patients receive 4 courses of adjuvant chemotherapy with FEC as in arm I, regimen A. Patients then receive sequential docetaxel IV over 1 hour once every 3 weeks for 4 courses.

Beginning within 4 weeks after completion of adjuvant chemotherapy, patients who are not concurrently enrolled in the Standardization of Breast Radiotherapy (START) trial receive localized radiotherapy once daily, 5 days a week, for 3-5 weeks, according to local practice.

Beginning within 4 weeks after completion of adjuvant chemotherapy, patients who are estrogen receptor and/or progesterone receptor positive receive oral tamoxifen once daily for at least 5 years.

Quality of life is assessed at baseline, before course 5, at 3-4 weeks after course 8, and then at 9, 12, 18, and 24 months after initiation of adjuvant chemotherapy.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 3,340 patients (1,670 per treatment arm) will be accrued for this study within 2 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: CMF regimen
  • Drug: cyclophosphamide
  • Drug: docetaxel
  • Drug: epirubicin hydrochloride
  • Drug: fluorouracil
  • Drug: methotrexate
  • Drug: tamoxifen citrate
  • Procedure: adjuvant therapy
  • Radiation: radiation therapy
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE


  • Histologically confirmed completely resected, invasive breast cancer for which adjuvant chemotherapy is indicated
  • No clinical or radiological evidence of locoregional or metastatic disease
  • No locally advanced tumors at diagnosis, indicated by any of the following:

    • Fixed tumors
    • Peau d'orange skin changes
    • Skin ulceration
    • Inflammatory changes (T4 or T3b, N2 disease)
  • No male breast cancer
  • No prior invasive breast cancer or bilateral breast cancer
  • Prior ductal carcinoma in situ or lobular carcinoma in situ is allowed
  • Must begin study chemotherapy within 8 weeks after definitive surgery
  • Hormone receptor status:

    • Estrogen receptor and progesterone receptor status known



  • Over 18


  • Female

Menopausal status:

  • Not specified

Performance status:

  • WHO 0-1

Life expectancy:

  • At least 2 years


  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL


  • Bilirubin normal
  • AST no greater than 1.5 times normal
  • Alkaline phosphatase no greater than 1.5 times normal


  • Creatinine no greater than 1.5 times normal


  • No myocardial infarction within the past 6 months
  • No congestive heart failure


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other invasive malignancy within the past 10 years except surgically cured nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No other serious medical illness that would limit life expectancy
  • No psychiatric condition that would preclude informed consent
  • No active uncontrolled bacterial, viral, or fungal infection


Biologic therapy:

  • No prior biologic therapy


  • See Disease Characteristics
  • No prior cytotoxic chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy (e.g., tamoxifen) during study chemotherapy
  • No concurrent hormone replacement therapy


  • No prior radiotherapy


  • See Disease Characteristics


  • At least 4 weeks since any prior unlicensed drugs
  • No other concurrent experimental drugs
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   United Kingdom
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00033683
Other Study ID Numbers  ICMJE CDR0000069311
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Institute of Cancer Research, United Kingdom
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jane Banerji Institute of Cancer Research, United Kingdom
PRS Account National Cancer Institute (NCI)
Verification Date June 2005

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