Combination Chemotherapy in Treating Women With Stage I Breast

Combination Chemotherapy in Treating Women With Stage I Breast

Combination Chemotherapy in Treating Women With Stage I Breast
Cancer
Status: Completed
Study Phase: Phase 3
Start Date: August 2002 | Completion Date: June 2013
Condition(s): Breast Cancer
Full Title of Study
Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And
Cyclophosphamide, In Women With Stage I Breast Cancer
Overview
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.
Study Details
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study,
Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose:
Treatment
Investigator Details
Lead Sponsor: UNICANCER
Study Chair: Pierre Kerbrat, MD, PhD Centre Eugene Marquis
Trial Location Details
Facility: Clinique Claude Bernard Albi, France
Facility: Centre Paul Papin Angers, France
Facility: Centre Hospitalier d'Annecy Annecy, France
Facility: Centre Hospitalier Victor Dupouy Argenteuil, France
Facility: Centre Hospital General Robert Ballanger Aulnay Sous Bois, France
Facility: Centre Hospitalier d'Auxerre Auxerre, France
Facility: Institut Sainte Catherine Avignon, France
Facility: Centre Hospitalier de la Cote Basque Bayonne, France
Facility: C.H.G. Beauvais Beauvais, France
Facility: Centre Hospitalier General Belfort, France
Facility: Institut Bergonie Bordeaux, France
Facility: Clinique Tivoli Bordeaux, France
Facility: Polyclinique Bordeaux Nord Aquitaine Boucher, France
Facility: Centre Hospitalier Docteur Duchenne Boulogne Sur Mer, France
Facility: Centre Hospitalier de Fleyriat Bourg En Bresse, France
Facility: Centre Hospitalier Jacques-Coeur Bourges, France
Facility: CHU Hopital A. Morvan Brest, France
Facility: Centre Hospitalier General Brive, France
Facility: Polyclinique Du Parc Centre Maurice Tubiana Caen, France
Facility: Centre Regional Francois Baclesse Caen, France
Facility: Centre Hospitalier Regional de Chambery Chambery, France
Facility: Clinique Prive Paul d'Egine Champigny-Sur-Marne, France
Facility: Centre Jean Perrin Clermont-Ferrand, France
Facility: Hopital Louis Pasteur Colmar, France
Facility: Clinique des Cedres Cornebarrieu, France
Facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc Dijon, France
Facility: Centre Hospitalier Draguignan Draguignan, France
Facility: CHU de Grenoble - Hopital de la Tronche Grenoble, France
Facility: Institut Prive de Cancerologie Grenoble, France
Facility: Centre Hospitalier Departemental La Roche Sur Yon, France
Facility: Centre Hospitalier de Lagny Lagny Sur Marne, France
Facility: Hopital Andre Mignot Le Chesnay, France
Facility: Centre Oscar Lambret Lille, France
Facility: Centre Hospitalier Bretagne Sud Lorient, France
Facility: Hopital Hotel Dieu Lyon, France
Facility: Hopital de la Croix Rousse Lyon, France
Facility: Centre Leon Berard Lyon, France
Facility: Hopital Edouard Herriot Lyon, France
Facility: Centre de Radiotherapie et Oncologie Saint-Faron Mareuil Les Meaux, France
Facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes Marseille, France
Facility: Hopital Notre-Dame de Bon Secours Metz, France
Facility: Centre Hospitalier General Andre Boulloche Montbeliard, France
Facility: Intercommunal Hospital Montfermeil, France
Facility: Centre Azureen de Cancerologie Mougins, France
Facility: Centre Hospitalier de Mulhouse Mulhouse, France
Facility: Clinique D'Occitanie Muret, France
Facility: Centre Regional Rene Gauducheau Nantes-Saint-Herblain, France
Facility: Centre Catherine de Sienne Nantes, France
Facility: Clinique Les Genets Narbonne, France
Facility: Clinique Hartmann Neuilly sur Seine, France
Facility: Hopital Saint Antoine Paris, France
Facility: Hopital Tenon Paris, France
Facility: C.H.G. De Pau Pau, France
Facility: Polyclinique Francheville Perigueux, France
Facility: Clinique Saint - Pierre Perpignan, France
Facility: Centre Hospitalier Lyon Sud Pierre Benite, France
Facility: CHU Poitiers Poitiers, France
Facility: Centre Hospitalier de Cornouaille Quimper, France
Facility: Centre Eugene Marquis Rennes, France
Facility: CHG Roanne Roanne, France
Facility: Centre Hospitalier de Rodez Rodez, France
Facility: Clinique Armoricaine De Radiologie Saint Brieuc, France
Facility: Centre Rene Huguenin Saint Cloud, France
Facility: Centre Paul Strauss Strasbourg, France
Facility: Centre Medico-Chirurgical Foch Suresnes, France
Facility: Polyclinique de L'Ormeau Tarbes, France
Facility: Institut Claudius Regaud Toulouse, France
Facility: Clinique Pasteur Toulouse, France
Facility: Clinique Du Parc Toulouse, France
Facility: Clinique du Chateau Toulouse, France
Facility: Hopital J. Ducuing Toulouse, France
Facility: Centre Alexis Vautrin Vandoeuvre-les-Nancy, France
Interventions
Drug: cyclophosphamide
Drug: epirubicin hydrochloride
Drug: fluorouracil
Information Source
ID Number: PACS05 UC-0140-0106
NCT Identifier: NCT00055679
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT00055679
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