Combination Chemotherapy in Treating Women With Stage I Breast Cancer - Full Text View

Sponsor:	Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00055679

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: cyclophosphamide Drug: epirubicin hydrochloride Drug: fluorouracil Drug: tamoxifen citrate Procedure: adjuvant therapy Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control
Official Title:	Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And Cyclophosphamide, In Women With Stage I Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cyclophosphamide Fluorouracil Tamoxifen Tamoxifen citrate Epirubicin hydrochloride Epirubicin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Efficacy, in terms of 5-year survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Length of survival with biological factors [ Designated as safety issue: No ]
Biological factors significant for prognosis and prediction of survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

Estimated Enrollment:	1512
Study Start Date:	August 2002

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055679

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Locations

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

Sponsors and Collaborators

Federation Nationale des Centres de Lutte Contre le Cancer

Investigators

Study Chair:

Pierre Kerbrat, MD, PhD

Centre Eugene Marquis

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000270763, FRE-FNCLCC-PACS-05/0106, EU-20239
Study First Received:	March 6, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00055679 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Cyclophosphamide
Selective Estrogen Receptor Modulators
Antibiotics, Antineoplastic
Estrogen Receptor Modulators
Neoplasms by Site
Therapeutic Uses

Alkylating Agents
Breast Diseases
Estrogen Antagonists
Skin Diseases
Antineoplastic Agents, Hormonal
Adjuvants, Immunologic
Breast Neoplasms
Tamoxifen
Epirubicin
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Fluorouracil
Myeloablative Agonists
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on November 25, 2009