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. Identifier: NCT00053911
Recruitment Status : Terminated
First Posted : February 6, 2003
Last Update Posted : December 16, 2014
Information provided by:

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 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: anastrozole Drug: cyclophosphamide Drug: docetaxel Drug: epirubicin hydrochloride Drug: fluorouracil Drug: goserelin acetate Drug: tamoxifen citrate Procedure: adjuvant therapy Phase 3

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2002
Actual Primary Completion Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Evaluation of the disease free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Evaluation of the overall survival [ Time Frame: 5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00053911

Clinique Claude Bernard
Albi, France, 81000
Centre Paul Papin
Angers, France, 49036
Centre Hospitalier d'Annecy
Annecy, France, 74011 Cedex
Institut Sainte Catherine
Avignon, France, 84082
Institut Bergonie
Bordeaux, France, 33076
C.H. Bourg En Bresse
Bourg En Bresse, France, 01012
CHU Hopital A. Morvan
Brest, France, 29609
Centre Hospitalier General
Brive, France, 19101
Centre Regional Francois Baclesse
Caen, France, 14076
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Centre Hospitalier Compiegne
Compiegne, France, 60321
Clinique du Petit Colmouilins
Harfleur, France, 76700
Centre Oscar Lambret
Lille, France, 59020
Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Hopital Notre-Dame de Bon Secours
Metz, France, 57038
C.H. General Andre Boulloche
Montbeliard, France, 25209
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Centre Hospitalier de Mulhouse
Mulhouse, France, 68051
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, France, 44805
Clinique Saint - Pierre
Perpignan, France
Centre Eugene Marquis
Rennes, France, 35042
Clinique Armoricaine De Radiologie
Saint Brieux, France, F-22015
Polyclinique de L'Ormeau
Tarbes, France, 65000
Institut Claudius Regaud
Toulouse, France, 31052
Hopital J. Ducuing
Toulouse, France
Institut Gustave Roussy
Villejuif, France, F-94805
Sponsors and Collaborators
Study Chair: Gilles Romieu, MD Institut du Cancer de Montpellier - Val d'Aurelle Identifier: NCT00053911     History of Changes
Other Study ID Numbers: PACS03
First Posted: February 6, 2003    Key Record Dates
Last Update Posted: December 16, 2014
Last Verified: December 2014

Keywords provided by UNICANCER:
recurrent breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antimetabolites, Antineoplastic
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal