Spots Global Cancer Trial Database for Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer
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Trial Identification
Brief Title: Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer
Official Title: Phase II Randomized Study of Two Different Schedules of Docetaxel or Paclitaxel for Metastatic Breast Cancer
Study ID: NCT00006120
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of docetaxel or paclitaxel in treating women who have unresectable locally advanced or metastatic breast cancer.
Detailed Description: OBJECTIVES: * Compare the response rate, progression free survival, and overall survival in women with unresectable locally advanced or metastatic breast cancer treated with two different schedules of docetaxel or paclitaxel. * Compare the toxicities and pharmacoeconomics of these four regimens in these patients. * Compare the quality of life of patients treated with these four regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, age, ECOG performance status, hormone receptor status (positive vs negative), metastasis to liver (yes vs no), and presence of disease progression following anthracyclines (yes vs no). Patients are randomized to one of four treatment arms. * Arm I: Patients receive docetaxel IV over 1 hour on day 1. * Arm II: Patients receive paclitaxel IV over 3 hours on day 1. * Arm III: Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36. * Arm IV: Patients receive paclitaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Courses repeat every 3 weeks (arms I and II) or every 8 weeks (arms III and IV) in the absence of disease progression or unacceptable toxicity. Quality of life is assessed prior to treatment and then every 8 weeks. PROJECTED ACCRUAL: A total of 165 patients will be accrued for this study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Centre Hospitalier d'Antibes, Antibes, , France
Centre Hospitalier Victor Dupouy, Argenteuil, , France
Institut Sainte Catherine, Avignon, , France
Clinique Floreal, Bagnolet, , France
Centre D'Oncologie Du Pays-Basque, Bayonne, , France
C.H.G. Beauvais, Beauvais, , France
Hopital Fontenoy, Chartres, , France
Centre Jean Perrin, Clermont-Ferrand, , France
Hopital Louis Mourier, Colombes, , France
Centre Hospitalier Laennec, Creil, , France
Hopital Intercommunal De Creteil, Creteil, , France
Hopital Drevon, Dijon, , France
Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie, Gien, , France
Centre Jean Bernard, Le Mans, , France
Hopital Desgenettes - Service de Medecine Interne, Lyon, , France
Centre de Radiotherapie et Oncologie Saint-Faron, Mareuil Les Meaux, , France
Hopital Saint Joseph, Marseille, , France
Hopital Notre-Dame de Bon Secours, Metz, , France
CH Meulan, Meulan, , France
Intercommunal Hospital, Montfermeil, , France
Centre Hospitalier de Mulhouse, Mulhouse, , France
Clinique Hartmann, Neuilly sur Seine, , France
American Hospital of Paris, Neuilly Sur Seine, , France
Clinique Geoffroy St. Hillaire, Paris, , France
Hotel Dieu de Paris, Paris, , France
Hopital Saint Antoine, Paris, , France
Hopital Tenon, Paris, , France
Clinique Ste - Marie, Pontoise, , France
Polyclinique De Courlancy, Reims, , France
Centre du Rouget, Sarcelles, , France
C.H. Senlis, Senlis, , France
Clinique de l'Orangerie, Strasbourg, , France
Clinique Pasteur, Toulouse, , France
Clinique Fleming, Tours, , France
Hopital de la Ville D'Esch-sur-Alzette, Esch-sur-Alzette, , Luxembourg
Contact Details
Name: Joseph Gligorov, MD
Affiliation: Hopital Tenon
Role: STUDY_CHAIR
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