Combination Chemotherapy in Treating Women With Stage I Breast Cancer

June 17, 2013 updated by: UNICANCER

Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And Cyclophosphamide, In Women With Stage I Breast Cancer

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 may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating early breast cancer.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the efficacy of 4 vs 6 courses of adjuvant fluorouracil, epirubicin, and cyclophosphamide, in terms of 5-year survival, in women with stage I breast cancer.
  • Compare the toxicity of these regimens in these patients.
  • Determine the correlation of length of survival with biological factors in patients treated with these regimens.
  • Determine biological factors significant for prognosis and prediction of survival of patients treated with these regimens.
  • Determine the overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive the same regimen as in arm I for up to 4 courses. After completion of chemotherapy, patients undergo radiotherapy 5 days a week for 6 weeks. Patients who are estrogen or progesterone receptor positive also receive oral tamoxifen daily for 5 years, beginning after completion of chemotherapy.

Patients are followed every 6 months for 5 years.

PROJECTED ACCRUAL: A total of 1,512 patients (756 per treatment arm) will be accrued for this study within 3 years.

Study Type

Interventional

Enrollment (Actual)

1512

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Albi, France, 81000
        • Clinique Claude Bernard
      • Angers, France, 49036
        • Centre Paul Papin
      • Annecy, France, 74011 Cedex
        • Centre Hospitalier d'Annecy
      • Argenteuil, France, 95107
        • Centre Hospitalier Victor Dupouy
      • Aulnay Sous Bois, France, 93602
        • Centre Hospital General Robert Ballanger
      • Auxerre, France, 89011
        • Centre Hospitalier d'Auxerre
      • Avignon, France, 84082
        • Institut Sainte Catherine
      • Bayonne, France, 64100
        • Centre Hospitalier de la Côte Basque
      • Beauvais, France, 60021
        • C.H.G. Beauvais
      • Belfort, France, 90000
        • Centre Hospitalier General
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Bordeaux, France, F-33000
        • Clinique Tivoli
      • Boucher, France, 33300
        • Polyclinique Bordeaux Nord Aquitaine
      • Boulogne Sur Mer, France, 62200
        • Centre Hospitalier Docteur Duchenne
      • Bourg En Bresse, France, 01012
        • Centre Hospitalier de Fleyriat
      • Bourges, France, 18016
        • Centre Hospitalier Jacques-Coeur
      • Brest, France, 29609
        • CHU Hopital A. Morvan
      • Brive, France, 19101
        • Centre Hospitalier General
      • Caen, France, 14076
        • Centre Regional Francois Baclesse
      • Caen, France, 14052
        • Polyclinique Du Parc Centre Maurice Tubiana
      • Chambery, France, 73011
        • Centre Hospitalier Regional de Chambery
      • Champigny-Sur-Marne, France, 94500
        • Clinique Prive Paul d'Egine
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Colmar, France, 68024
        • Hôpital Louis Pasteur
      • Cornebarrieu, France, 31700
        • Clinique des Cèdres
      • Dijon, France, 21079
        • Centre de Lutte Contre le Cancer Georges-Francois Leclerc
      • Draguignan, France, 83300
        • Centre Hospitalier Draguignan
      • Grenoble, France, 38043
        • CHU de Grenoble - Hopital de la Tronche
      • Grenoble, France, 38100
        • Institut Prive de Cancerologie
      • La Roche Sur Yon, France, 85025
        • Centre Hospitalier departemental
      • Lagny Sur Marne, France, 77405
        • Centre Hospitalier de Lagny
      • Le Chesnay, France, 78157
        • Hôpital André Mignot
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lorient, France, 56322
        • Centre Hospitalier Bretagne Sud
      • Lyon, France, 69373
        • Centre Leon Berard
      • Lyon, France, 69317
        • Hôpital de La Croix Rousse
      • Lyon, France, 69437
        • Hôpital Edouard Herriot
      • Lyon, France, 69288
        • Hôpital Hotel Dieu
      • Mareuil Les Meaux, France, 77100
        • Centre de Radiotherapie et Oncologie Saint-Faron
      • Marseille, France, 13273
        • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
      • Metz, France, 57038
        • Hopital Notre-Dame de Bon Secours
      • Montbeliard, France, 25209
        • Centre Hospitalier General Andre Boulloche
      • Montfermeil, France, 93370
        • Intercommunal Hospital
      • Mougins, France, 06250
        • Centre Azuréen de Cancérologie
      • Mulhouse, France, 68051
        • Centre Hospitalier de Mulhouse
      • Muret, France, 31600
        • Clinique D'Occitanie
      • Nantes, France, 02
        • Centre Catherine de Sienne
      • Nantes-Saint-Herblain, France, 44805
        • Centre Regional Rene Gauducheau
      • Narbonne, France, 11100
        • Clinique Les Genets
      • Neuilly sur Seine, France, 92200
        • Clinique Hartmann
      • Paris, France, 75970
        • Hôpital Tenon
      • Paris, France, 75571
        • Hopital Saint Antoine
      • Pau, France, 64046 Universite Cedex
        • C.H.G. De Pau
      • Perigueux, France, 24004
        • Polyclinique Francheville
      • Perpignan, France
        • Clinique Saint - Pierre
      • Pierre Benite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Poitiers, France, 86021
        • CHU Poitiers
      • Quimper, France, 29107
        • Centre Hospitalier de Cornouaille
      • Rennes, France, 35042
        • Centre Eugène Marquis
      • Roanne, France, F-42300
        • CHG Roanne
      • Rodez, France, 12027
        • Centre Hospitalier de Rodez
      • Saint Brieuc, France, F-22015
        • Clinique Armoricaine de Radiologie
      • Saint Cloud, France, 92211
        • Centre René Huguenin
      • Strasbourg, France, 67065
        • Centre Paul Strauss
      • Suresnes, France, 92151
        • Centre Médico-Chirurgical Foch
      • Tarbes, France, 65000
        • Polyclinique de l'Ormeau
      • Toulouse, France, 31052
        • Institut Claudius Regaud
      • Toulouse, France, 31076
        • Clinique Pasteur
      • Toulouse, France, 31078
        • Clinique du Parc
      • Toulouse, France, 31080
        • Clinique du Chateau
      • Toulouse, France
        • Hopital J. Ducuing
      • Vandoeuvre-les-Nancy, France, 54511
        • Centre Alexis Vautrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed nonmetastatic, unilateral adenocarcinoma of the breast

    • Stage I
    • No clinically or radiologically suspicious metastases
    • No positive sentinel lymph nodes by immunohistochemistry for tumors less than 2 cm

    • No clinically proven positive axillary lymph nodes

      • Tumor cells found on immunohistochemistry only allowed
    • No clinically or radiologically contralateral suspicious lesions
  • No deeply adherent disease
  • No cutaneous invasion
  • No inflammatory disease

  • Complete surgical resection within the past 42 days

    • At least 8 lymph nodes removed
  • Tumor at least 1 cm with no residual disease

  • Presenting with at least 1 of the following factors of a poor prognosis:

    • Tumor greater than 2 cm
    • Hormone receptor negative tumor
    • Grade II or III
    • 35 years old or under

  • Hormone receptor status:

    • Positive or negative

PATIENT CHARACTERISTICS:

Age

  • 18 to 65

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

  • Bilirubin no greater than 1.25 times upper limit of normal (ULN)
  • AST and ALT no greater than 1.25 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN
  • No chronic hepatitis B
  • No active hepatitis C

Renal

  • Creatinine no greater than 1.25 times ULN

Pulmonary

  • FEV normal

Other

  • Not pregnant or nursing
  • HIV negative
  • No prior breast cancer or other malignancy
  • No familial, social, or geographical reason that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • No prior anticancer hormone therapy

Radiotherapy

  • No prior radiotherapy

Surgery

  • See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 6 FEC
6 cycles of CYCLOPHOSPHAMIDE + EPIRUBICINE + 5-FLUOROURACILE
Drug: cyclophosphamide
Drug: fluorouracil
Drug: epirubicin hydrochloride
Experimental: 4 FEC
4 cycles of CYCLOPHOSPHAMIDE + EPIRUBICINE + 5-FLUOROURACILE
Drug: cyclophosphamide
Drug: fluorouracil
Drug: epirubicin hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy, in terms of 5-year survival
Time Frame: 5 years from randomization
5 years from randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Event free survival
Time Frame: 5 years from randomization
5 years from randomization
Toxicity
Time Frame: 5 years from randomization
5 years from randomization
Biological factors significant for prognosis and prediction of survival
Time Frame: 5 years from randomization
5 years from randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Investigators

  • Study Chair: Pierre Kerbrat, MD, PhD, Centre Eugène Marquis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 6, 2003

First Submitted That Met QC Criteria

March 6, 2003

First Posted (Estimate)

March 7, 2003

Study Record Updates

Last Update Posted (Estimate)

June 18, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PACS05 UC-0140-0106
  • FRE-FNCLCC-PACS-05/0106
  • EU-20239

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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