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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Women With Stage I Breast Cancer  Combination Chemotherapy in Treating Women With Stage I Breast Cancer
Combination Chemotherapy in Treating Women With Stage I Breast Cancer
For Condition: stage 1 breast cancer
Status: Recruiting
Sponsor(s): Federation Nationale des Centres de Lutte Contre le Cancer ,
Synopsis: 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 chemotherapyregimen is more effective in treating early breast cancer. PURPOSE: Randomizedphase III trial to determine the effectiveness of different regimens of combination chemotherapy in treating women who have stage I breast cancer.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PierreKerbrat, Study Chair, Centre Eugene Marquis
Intercommunal Hospital *Recruiting*
Montfermeil, , 93370
France
Recruiting Mostefa Bennamoun 33-1-4850-1808
Centre Eugene Marquis *Recruiting*
Rennes, , 35042
France
Recruiting Pierre Kerbrat 33-299-253-280
Centre Leon Berard *Recruiting*
Lyon, , 69373
France
Recruiting Pierre Biron 33-78-782-641
Centre Hospitalier Jacques-Coeur *Recruiting*
Bourges, , 18016
France
Recruiting Christine Berger 33-02-4848-4848
Centre Hospitalier Draguignan *Recruiting*
Draguignan, , 83300
France
Recruiting Bruno Valenza 33-04-9460-5000
Centre Hospitalier Le Havre *Recruiting*
Le Havre, , 76083
France
Recruiting Sylvie Murawa-Durand 33-02-3273-3130
Institut J. Paoli and I. Calmettes *Recruiting*
Marseille, , 13273
France
Recruiting Patrice Viens 33-4-91-223-537
Centre Hospital General Robert Ballanger *Recruiting*
Aulnay-sous-Bois, , 93602
France
Recruiting Claude Boiron 33-1-4936-7123
Clinique Du Parc *Recruiting*
Toulouse, , 31078
France
Recruiting Mathilde Martinez 33-5-61-36-69-38
Centre Regional Francois Baclesse *Recruiting*
Caen, , 14076
France
Recruiting Thierry Delozier 33-23-145-5015
Clinique du Chateau *Recruiting*
Toulouse, , 31080
France
Recruiting Martial Boisseau 33-05-6133-2228
Polyclinique de L'Ormeau *Recruiting*
Tarbes, , 65000
France
Recruiting Bernard Couderc 33-056-293-5929
C.H. General Andre Boulloche *Recruiting*
Montbeliard, , 25209
France
Recruiting A. Monnier 33-38-131-3515
Centre Hospitalier Docteur Duchenne *Recruiting*
Boulogne-sur-Mer, , 62200
France
Recruiting Zoher Merad-Boudia 33-3-21-99-3333
Hopital Tenon *Recruiting*
Paris, , 75970
France
Recruiting Jean-Pierre Lotz 33-01-5609-3476
Institut Claudius Regaud *Recruiting*
Toulouse, , 31052
France
Recruiting Henri Roche 33-56-14-24-129
Centre Hospitalier de Mulhouse *Recruiting*
Mulhouse, , 68051
France
Recruiting Anne-Marie Elgard 33-3-8964-6464
Polyclinique Du Parc Centre Maurice Tubiana *Recruiting*
Caen, , 14052
France
Recruiting Patrick Allain 33-23-182-8282
Institut Sainte Catherine *Recruiting*
Avignon, , 84082
France
Recruiting Daniel Serin 33-490-276-263
Centre Hospitalier de la Cote Basque *Recruiting*
Bayonne, , 64100
France
Recruiting Stephane Remy 33-05-5944-3535
CMC Les Ormeaux *Recruiting*
Le Havre, , 76600
France
Recruiting Gilles Piot 33-2-3274-3362
Hopital Notre-Dame de Bon Secours *Recruiting*
Metz, , 57038
France
Recruiting Sabine Walter 33-387-553-554
Centre Rene Huguenin *Recruiting*
Saint Cloud, , 92211
France
Recruiting E.G.C. Brain 33-147-111-515
Centre Hospitalier Bretagne Sud *Recruiting*
Lorient, , 56322
France
Recruiting Marie-Josephe Foucher-Goudier 33-02-9764-9193
C.H.G. De Pau *Recruiting*
Pau, , 64046 Universite Cedex
France
Recruiting Maxime Malet 33-5-59-72-67-96
Hopital Louis Pasteur *Recruiting*
Colmar, , 68024
France
Recruiting Bruno Audhuy 33-389-124-102
Centre Antoine Lacassagne *Recruiting*
Nice, , 06189
France
Recruiting Moise Namer 33-93-492-031-351
Hopital Hotel Dieu *Recruiting*
Lyon, , 69288
France
Recruiting Francois Golfier 33-4-7241-3249
Hopital Andre Mignot *Recruiting*
Le Chesnay, , 78157
France
Recruiting Didier Mayeur 33-1-3963-8909
Centre Hospitalier de Rodez *Recruiting*
Rodez, , 12027
France
Recruiting Alain Maare 33-05-6575-1760
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc *Recruiting*
Dijon, , 21079
France
Recruiting Francoise Mayer 33-03-8073-7528
Institut Prive de Cancerologie *Recruiting*
Grenoble, , 38100
France
Recruiting D. Assouline 33-76-33-55-50
Centre Paul Papin *Recruiting*
Angers, , 49036
France
Recruiting Alain Lortholary 33-2-4135-2700
Centre Hospitalier d'Annecy *Recruiting*
Annecy, , 74011 Cedex
France
Recruiting Jean Datchary 33-04-50-88-33-50
Centre Hospitalier de Fleyriat *Recruiting*
Bourg-en-Bresse, , 01012
France
Recruiting Hubert Orfeuvre 33-04-7445-43-38
Polyclinique Bordeaux Nord Aquitaine *Recruiting*
Boucher, , 33300
France
Recruiting Nadine Dohollou 33-5-56-43-73-54
Centre Regional Rene Gauducheau *Recruiting*
Nantes-Saint-Herblain, , 44805
France
Recruiting Mario Campone 33-02-4067-9977
Hopital Saint Antoine *Recruiting*
Paris, , 75012
France
Recruiting Christophe Tournigand 33-1-4928-2329
Centre de Radiotherapie et Oncologie Saint-Faron *Recruiting*
Mareuil-les-Meaux, , 77100
France
Recruiting Jacques Mandet 33-16-43-34-848
CHU Poitiers *Recruiting*
Poitiers, , 86021
France
Recruiting Hugues Bourgeois 33-05-4944-4538
Polyclinique de Francheville *Recruiting*
Perigueux, , 24004
France
Recruiting Charles-Briac Levache 33-5-53-06-41-40
Clinique D'Occitanie *Recruiting*
Muret, , 31600
France
Recruiting Marion Montastruc 33-5-61-51-88-92
Centre Hospitalier General *Recruiting*
Belfort, , 90000
France
Recruiting Gerard Poulin 33-384-574-049
CHU Rangueil *Recruiting*
Toulouse, , 31403
France
Recruiting Henri Roche 33-05-6132-2533
Centre Hospitalier de Cornouaille *Recruiting*
Quimper, , 29107
France
Recruiting Dominique Besson 33-02-9852-6060
Clinique Les Genets *Recruiting*
Narbonne, , 11100
France
Recruiting Andre Mathieu 33-4-68-65-10-52
Clinique Pasteur *Recruiting*
Toulouse, , 31076
France
Recruiting Nicolas Albin 33-05-6221-3131
Centre Hospitalier Departemental *Recruiting*
La Roche-sur-Yon, , 85025
France
Recruiting Franck Priou 33-02-5144-6161
Centre Paul Strauss *Recruiting*
Strasbourg, , 67065
France
Recruiting Thierry Petit 33-3-88-25-24-56
Centre Hospitalier Lyon Sud *Recruiting*
Pierre-Benite, , 69495
France
Recruiting Giles Freyer 33-04-7886-3324
CHU Hopital A. Morvan *Recruiting*
Brest, , 29609
France
Recruiting Jean-Paul Labat 0298 22 3395
Clinique Claude Bernard *Recruiting*
Albi, , 81000
France
Recruiting Phillipe Houyau 33-05-6377-7750
Clinique Tivoli *Recruiting*
Bordeaux, , F-33030
France
Recruiting Dominique Jaubert 33-556-116-087
Clinique Armoricaine De Radiologie *Recruiting*
Saint Brieux, , F-22015
France
Recruiting Anne-Claire Hardy-Bessard 33-2-96-75-22-16
Centre Hospitalier de Lagny *Recruiting*
Lagny Sur Marne, , 77405
France
Recruiting Annie Bellaiche 33-01-6430-7048
Clinique Hartmann *Recruiting*
Neuilly-sur-Seine, , 92200
France
Recruiting Jean-Michel Vannetzel 33-01-4759-0000
Clinique Saint - Pierre *Recruiting*
Perpignan, ,
France
Recruiting Daniel Castera 33-09-6839-0742
Centre Hospitalier Victor Dupouy *Recruiting*
Argenteuil, , 95107
France
Recruiting Sophie Barthier 33-01-3423-2089
Hopital J. Ducuing *Recruiting*
Toulouse, ,
France
Recruiting Stephane Aczel 0561 77 3439
C.H.G. Beauvais *Recruiting*
Beauvais, , 60021
France
Recruiting J.L. Dutel 33-344-112-309
Institut Bergonie *Recruiting*
Bordeaux, , 33076
France
Recruiting Louis Mauriac 33-56-333-258
CHU de Grenoble - Hopital de la Tronche *Recruiting*
Grenoble, , 38043
France
Recruiting Mireille Mousseau 33-76-765-451
Centre Jean Perrin *Recruiting*
Clermont-Ferrand, , 63011
France
Recruiting Herve Cure 33-04-73-278-139
Clinique Prive Paul d'Egine *Recruiting*
Champigny-sur-Marne, , 94500
France
Recruiting Jean-Victor Chantelard 33-01-4270-6001
Centre Hospitalier d'Auxerre *Recruiting*
Auxerre, , 89011
France
Recruiting Isabelle Cauvin 33-03-8648-4848
Centre Hospitalier Regional de Chambery *Recruiting*
Chambery, , 73011
France
Recruiting Cecile Agostini 33-4-79-96-61-81
Institut Curie - Section Medicale *Recruiting*
Paris, , 75248
France
Recruiting Pierre Pouillart 33-1-44-32-46-80
Centre Alexis Vautrin *Recruiting*
Vandoeuvre-les-Nancy, , 54511
France
Recruiting Maria Rios 33-03-8359-8461
Clinique des Cedres *Recruiting*
Cornebarrieu, , 31700
France
Recruiting Veronique Fabre 33-5-62-13-32-03
Centre Oscar Lambret *Recruiting*
Lille, , 59020
France
Recruiting Veronique Servent 33-03-2029-5262
CHG Roanne *Recruiting*
Roanne, , F-42300
France
Recruiting M.C. Gouttebel 33-4-77-44-33-96
Hopital de la Croix Rousse *Recruiting*
Lyon, , 69317
France
Recruiting Pierre de Saint-Hilaire 33-04-7207-1639
Centre Hospitalier General *Recruiting*
Brive, , 19101
France
Recruiting Bernard Leduc 0555-92-60-00
Additional Information:
Study ID Numbers: CDR0000270763; EU-20239,FRE-FNCLCC-PACS-05/0106
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055679
Other Stage 1 Breast Cancer Studies:
1. Clodronate With or Without Chemotherapy and/or Tamoxifen in Treating Women With Stage I or Stage II Breast Cancer
2. Epirubicin Combined With Docetaxel Before Surgery in Treating Women With Early Breast Cancer
3. Correlation of Menstrual Cycle Phase at Time of Primary Surgery With 5-Year Disease-Free Survival in Women With Stage I or Stage II Breast Cancer
4. Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer
5. Hormone Replacement Therapy and the Risk of Breast Cancer Recurrence in Women With Previous Early Stage Breast Cancer
Related Studies:
Other stage 1 breast cancer Clinical Trials
Other Clinical Trials
Other Paris Clinical Trials
Combination Chemotherapy in Treating Women With Stage I Breast Cancer
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