Combination Chemotherapy in Treating Women With Stage I Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00055679
- Lead Sponsor
- UNICANCER
- 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 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1512
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 6 FEC epirubicin hydrochloride 6 cycles of CYCLOPHOSPHAMIDE + EPIRUBICINE + 5-FLUOROURACILE 4 FEC epirubicin hydrochloride 4 cycles of CYCLOPHOSPHAMIDE + EPIRUBICINE + 5-FLUOROURACILE 6 FEC cyclophosphamide 6 cycles of CYCLOPHOSPHAMIDE + EPIRUBICINE + 5-FLUOROURACILE 6 FEC fluorouracil 6 cycles of CYCLOPHOSPHAMIDE + EPIRUBICINE + 5-FLUOROURACILE 4 FEC cyclophosphamide 4 cycles of CYCLOPHOSPHAMIDE + EPIRUBICINE + 5-FLUOROURACILE 4 FEC fluorouracil 4 cycles of CYCLOPHOSPHAMIDE + EPIRUBICINE + 5-FLUOROURACILE
- Primary Outcome Measures
Name Time Method Efficacy, in terms of 5-year survival 5 years from randomization
- Secondary Outcome Measures
Name Time Method Event free survival 5 years from randomization Toxicity 5 years from randomization Biological factors significant for prognosis and prediction of survival 5 years from randomization
Trial Locations
- Locations (71)
Institut Sainte Catherine
🇫🇷Avignon, France
Polyclinique Bordeaux Nord Aquitaine
🇫🇷Boucher, France
Centre Hospitalier Docteur Duchenne
🇫🇷Boulogne Sur Mer, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
🇫🇷Dijon, France
Centre de Radiotherapie et Oncologie Saint-Faron
🇫🇷Mareuil Les Meaux, France
Hopital Hotel Dieu
🇫🇷Lyon, France
C.H.G. Beauvais
🇫🇷Beauvais, France
Centre Hospitalier General
🇫🇷Brive, France
Centre Hospitalier de Fleyriat
🇫🇷Bourg En Bresse, France
CHU Hopital A. Morvan
🇫🇷Brest, France
Clinique des Cedres
🇫🇷Cornebarrieu, France
Intercommunal Hospital
🇫🇷Montfermeil, France
Centre Hospitalier de Mulhouse
🇫🇷Mulhouse, France
Centre Regional Rene Gauducheau
🇫🇷Nantes-Saint-Herblain, France
Clinique Les Genets
🇫🇷Narbonne, France
Centre Hospitalier Departemental
🇫🇷La Roche Sur Yon, France
Clinique Tivoli
🇫🇷Bordeaux, France
Centre Hospitalier Jacques-Coeur
🇫🇷Bourges, France
Polyclinique Du Parc Centre Maurice Tubiana
🇫🇷Caen, France
Centre Regional Francois Baclesse
🇫🇷Caen, France
Clinique Prive Paul d'Egine
🇫🇷Champigny-Sur-Marne, France
Hopital Louis Pasteur
🇫🇷Colmar, France
Centre Hospitalier Draguignan
🇫🇷Draguignan, France
Centre Leon Berard
🇫🇷Lyon, France
Centre Hospitalier de Lagny
🇫🇷Lagny Sur Marne, France
Clinique Claude Bernard
🇫🇷Albi, France
Institut Bergonie
🇫🇷Bordeaux, France
Centre Hospitalier Regional de Chambery
🇫🇷Chambery, France
CHU de Grenoble - Hopital de la Tronche
🇫🇷Grenoble, France
Hopital Andre Mignot
🇫🇷Le Chesnay, France
Hopital de la Croix Rousse
🇫🇷Lyon, France
Centre Azureen de Cancerologie
🇫🇷Mougins, France
Clinique D'Occitanie
🇫🇷Muret, France
CHU Poitiers
🇫🇷Poitiers, France
CHG Roanne
🇫🇷Roanne, France
Centre Rene Huguenin
🇫🇷Saint Cloud, France
Hopital J. Ducuing
🇫🇷Toulouse, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France
Clinique du Chateau
🇫🇷Toulouse, France
Centre Oscar Lambret
🇫🇷Lille, France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
🇫🇷Marseille, France
Hopital Notre-Dame de Bon Secours
🇫🇷Metz, France
Centre Hospitalier General Andre Boulloche
🇫🇷Montbeliard, France
Hopital Saint Antoine
🇫🇷Paris, France
Clinique Hartmann
🇫🇷Neuilly sur Seine, France
C.H.G. De Pau
🇫🇷Pau, France
Polyclinique Francheville
🇫🇷Perigueux, France
Clinique Saint - Pierre
🇫🇷Perpignan, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
Centre Eugene Marquis
🇫🇷Rennes, France
Clinique Armoricaine De Radiologie
🇫🇷Saint Brieuc, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Centre Medico-Chirurgical Foch
🇫🇷Suresnes, France
Polyclinique de L'Ormeau
🇫🇷Tarbes, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Clinique Du Parc
🇫🇷Toulouse, France
Centre Hospital General Robert Ballanger
🇫🇷Aulnay Sous Bois, France
Centre Paul Papin
🇫🇷Angers, France
Centre Hospitalier d'Annecy
🇫🇷Annecy, France
Centre Hospitalier Victor Dupouy
🇫🇷Argenteuil, France
Centre Hospitalier d'Auxerre
🇫🇷Auxerre, France
Centre Hospitalier de la Cote Basque
🇫🇷Bayonne, France
Institut Prive de Cancerologie
🇫🇷Grenoble, France
Hopital Tenon
🇫🇷Paris, France
Centre Hospitalier Bretagne Sud
🇫🇷Lorient, France
Centre Catherine de Sienne
🇫🇷Nantes, France
Centre Hospitalier de Cornouaille
🇫🇷Quimper, France
Centre Hospitalier de Rodez
🇫🇷Rodez, France
Clinique Pasteur
🇫🇷Toulouse, France
Hopital Edouard Herriot
🇫🇷Lyon, France