Combination Chemotherapy Compared With Observation After Surgery in Treating Women With Relapsed Nonmetastatic Breast Cancer
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, and giving them after surgery, may kill any remaining tumor cells following surgery. It is not yet known whether combination chemotherapy is more effective than observation in treating relapsed nonmetastatic breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with that of observation in treating women who have undergone surgery for relapsed nonmetastatic breast cancer.
Drug: epirubicin hydrochloride
Drug: goserelin acetate
Drug: tamoxifen citrate
Procedure: adjuvant therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Randomized And Multicentric Phase III Study Evaluating The Benefit By Using A Chemotherapy With FEC 100 And Docetaxel In Non Metastatic Breast Cancer Which Has Relapsed After A Conservative Surgery|
- Evaluation of the disease free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Evaluation of the overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2002|
|Primary Completion Date:||April 2004 (Final data collection date for primary outcome measure)|
- Compare the efficacy of adjuvant cyclophosphamide, epirubicin, and fluorouracil vs observation, in terms of disease-free 5-year survival, in women who have undergone resection for relapsed nonmetastatic breast cancer after initial conservative surgery.
- Compare the overall survival of women treated with these regimens.
- Determine the tolerance of these women to the chemotherapy regimen.
- Correlate prognostic factors of survival with efficacy of the chemotherapy regimen in these women.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to menopausal status and participating center. Patients are randomized to 1 of 2 treatment arms. Study begins within 42 days after resection of recurrent disease.
- Arm I: Patients receive fluorouracil IV over 1 hour, epirubicin IV over 1 hour, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients are examined on days 1 and 63.
Patients who are hormone receptor positive also receive one of the following hormonal therapy regimens, depending on menopausal status:
- Oral tamoxifen daily for 5 years
- Oral tamoxifen daily for 5 years and oral luteinizing hormone-releasing hormone (LHRH) agonist therapy (e.g., goserelin) for 3 years
- Oral LHRH agonist therapy (e.g., goserelin) for 3 years
- Oral antiaromatase therapy (e.g., anastrozole) for 5 years Patients also undergo radiotherapy and may also undergo second complete resection.
Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 370 patients (185 per treatment arm) will be accrued for this study within 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053911
|Clinique Claude Bernard|
|Albi, France, 81000|
|Centre Paul Papin|
|Angers, France, 49036|
|Centre Hospitalier d'Annecy|
|Annecy, France, 74011 Cedex|
|Institut Sainte Catherine|
|Avignon, France, 84082|
|Bordeaux, France, 33076|
|C.H. Bourg En Bresse|
|Bourg En Bresse, France, 01012|
|CHU Hopital A. Morvan|
|Brest, France, 29609|
|Centre Hospitalier General|
|Brive, France, 19101|
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Centre Hospitalier Compiegne|
|Compiegne, France, 60321|
|Clinique du Petit Colmouilins|
|Harfleur, France, 76700|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Institut J. Paoli and I. Calmettes|
|Marseille, France, 13273|
|Hopital Notre-Dame de Bon Secours|
|Metz, France, 57038|
|C.H. General Andre Boulloche|
|Montbeliard, France, 25209|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Centre Hospitalier de Mulhouse|
|Mulhouse, France, 68051|
|Centre Regional Rene Gauducheau|
|Nantes-Saint Herblain, France, 44805|
|Clinique Saint - Pierre|
|Centre Eugene Marquis|
|Rennes, France, 35042|
|Clinique Armoricaine De Radiologie|
|Saint Brieux, France, F-22015|
|Polyclinique de L'Ormeau|
|Tarbes, France, 65000|
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Hopital J. Ducuing|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Study Chair:||Gilles Romieu, MD||Institut du Cancer de Montpellier - Val d'Aurelle|