We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Combination Chemotherapy Compared With Observation After Surgery in Treating Women With Relapsed Nonmetastatic 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.
ClinicalTrials.gov Identifier: NCT00053911
Recruitment Status : Terminated
First Posted : February 6, 2003
Last Update Posted : December 16, 2014
Information provided by:

February 5, 2003
February 6, 2003
December 16, 2014
November 2002
April 2004   (Final data collection date for primary outcome measure)
Evaluation of the disease free survival [ Time Frame: 5 years ]
Not Provided
Complete list of historical versions of study NCT00053911 on ClinicalTrials.gov Archive Site
Evaluation of the overall survival [ Time Frame: 5 years ]
Not Provided
Not Provided
Not Provided
Combination Chemotherapy Compared With Observation After Surgery in Treating Women With Relapsed Nonmetastatic Breast Cancer
Randomized And Multicentric Phase III Study Evaluating The Benefit By Using A Chemotherapy With FEC 100 And Docetaxel In Non Metastatic Breast Cancer Which Has Relapsed After A Conservative Surgery

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 remaining tumor cells following surgery. It is not yet known whether combination chemotherapy is more effective than observation in treating relapsed nonmetastatic breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with that of observation in treating women who have undergone surgery for relapsed nonmetastatic breast cancer.


  • Compare the efficacy of adjuvant cyclophosphamide, epirubicin, and fluorouracil vs observation, in terms of disease-free 5-year survival, in women who have undergone resection for relapsed nonmetastatic breast cancer after initial conservative surgery.
  • Compare the overall survival of women treated with these regimens.
  • Determine the tolerance of these women to the chemotherapy regimen.
  • Correlate prognostic factors of survival with efficacy of the chemotherapy regimen in these women.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to menopausal status and participating center. Patients are randomized to 1 of 2 treatment arms. Study begins within 42 days after resection of recurrent disease.

  • Arm I: Patients receive fluorouracil IV over 1 hour, epirubicin IV over 1 hour, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients are examined on days 1 and 63.

Patients who are hormone receptor positive also receive one of the following hormonal therapy regimens, depending on menopausal status:

  • Oral tamoxifen daily for 5 years
  • Oral tamoxifen daily for 5 years and oral luteinizing hormone-releasing hormone (LHRH) agonist therapy (e.g., goserelin) for 3 years
  • Oral LHRH agonist therapy (e.g., goserelin) for 3 years
  • Oral antiaromatase therapy (e.g., anastrozole) for 5 years Patients also undergo radiotherapy and may also undergo second complete resection.

Patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 370 patients (185 per treatment arm) will be accrued for this study within 3 years.

Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Breast Cancer
  • Drug: anastrozole
  • Drug: cyclophosphamide
  • Drug: docetaxel
  • Drug: epirubicin hydrochloride
  • Drug: fluorouracil
  • Drug: goserelin acetate
  • Drug: tamoxifen citrate
  • Procedure: adjuvant therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Not Provided
Not Provided
April 2004   (Final data collection date for primary outcome measure)


  • Histologically confirmed adenocarcinoma of the breast

    • No contralateral breast cancer
  • Local tumor recurrence more than 6 months after conservative surgery
  • Complete or conservative resection of the recurrent tumor NOTE: Initial complete surgical resection not allowed
  • No local inflammatory disease or disease that is not amenable to complete surgical resection
  • No positive axillary lymph nodes
  • No distant metastases, including subclavicular lymph nodes
  • Hormone receptor status:

    • Hormone receptor status known



  • 18 to 65


  • Female

Menopausal status

  • Menopausal status known

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


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


  • Bilirubin no greater than upper limit of normal (ULN)
  • Transaminases no greater than 1.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN
  • No chronic hepatitis B
  • No active hepatitis C


  • Not specified


  • Cardiac function normal by echocardiogram or isotopes


  • No contraindications to anthracyclines such as any of the following:

    • Prior doxorubicin over 300 mg/m^2
    • Prior epirubicin over 600 mg/m^2
    • Prior mitoxantrone over 90 mg/m^2
  • No other invasive malignancy
  • No chronic somatic or psychiatric condition that would preclude study participation
  • No familial, social, geographic, or psychological reason that would preclude study participation
  • Not pregnant
  • Fertile patients must use effective contraception
  • HIV negative
  • CA 153 no greater than 2 times ULN


Biologic therapy

  • Not specified


  • See Patient Characteristics-Other
  • No prior neoadjuvant chemotherapy

Endocrine therapy

  • No prior neoadjuvant hormonal therapy


  • No prior neoadjuvant radiotherapy


  • See Disease Characteristics
  • At least 41 days since prior surgery
Sexes Eligible for Study: Female
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Study Chair: Gilles Romieu, MD Institut du Cancer de Montpellier - Val d'Aurelle
December 2014

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