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Sponsored by: |
Federation Nationale des Centres de Lutte Contre le Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00053911 |
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.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: anastrozole Drug: cyclophosphamide Drug: docetaxel Drug: epirubicin hydrochloride Drug: fluorouracil Drug: goserelin Drug: tamoxifen citrate Procedure: adjuvant therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
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 |
Study Start Date: | November 2002 |
OBJECTIVES:
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.
Patients who are hormone receptor positive also receive one of the following hormonal therapy regimens, depending on menopausal status:
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the breast
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
No contraindications to anthracyclines such as any of the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
France | |
C.H. Bourg En Bresse | |
Bourg En Bresse, France, 01012 | |
C.H. General Andre Boulloche | |
Montbeliard, France, 25209 | |
Centre Eugene Marquis | |
Rennes, France, 35042 | |
Centre Hospitalier Compiegne | |
Compiegne, France, 60321 | |
Centre Hospitalier d'Annecy | |
Annecy, France, 74011 Cedex | |
Centre Hospitalier de Mulhouse | |
Mulhouse, France, 68051 | |
Centre Hospitalier General | |
Brive, France, 19101 | |
Centre Jean Perrin | |
Clermont-Ferrand, France, 63011 | |
Centre Oscar Lambret | |
Lille, France, 59020 | |
Centre Paul Papin | |
Angers, France, 49036 | |
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | |
Montpellier, France, 34298 | |
Centre Regional Francois Baclesse | |
Caen, France, 14076 | |
Centre Regional Rene Gauducheau | |
Nantes-Saint Herblain, France, 44805 | |
Polyclinique de L'Ormeau | |
Tarbes, France, 65000 | |
Clinique Armoricaine De Radiologie | |
Saint Brieux, France, F-22015 | |
Clinique Claude Bernard | |
ALBI, France, 81000 | |
Clinique du Petit Colmouilins | |
Harfleur, France, 76700 | |
Clinique Saint - Pierre | |
Perpignan, France | |
Hopital J. Ducuing | |
Toulouse, France | |
Hopital Notre-Dame de Bon Secours | |
Metz, France, 57038 | |
Institut Bergonie | |
Bordeaux, France, 33076 | |
Institut Claudius Regaud | |
Toulouse, France, 31052 | |
Institut Gustave Roussy | |
Villejuif, France, F-94805 | |
Institut J. Paoli and I. Calmettes | |
Marseille, France, 13273 | |
Institut Sainte Catherine | |
Avignon, France, 84082 | |
CHU Hopital A. Morvan | |
Brest, France, 29609 |
Study Chair: | Gilles Romieu, MD | Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle |
Study ID Numbers: | CDR0000269549, FRE-FNCLCC-PACS-03/003, EU-20237 |
Study First Received: | February 5, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00053911 |
Health Authority: | United States: Federal Government |
recurrent breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Docetaxel Anastrozole Skin Diseases Fluorouracil Citric Acid Goserelin |
Breast Neoplasms Cyclophosphamide Tamoxifen Epirubicin Breast Diseases Recurrence |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Antibiotics, Antineoplastic Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Neoplasms by Site |
Therapeutic Uses Aromatase Inhibitors Alkylating Agents Estrogen Antagonists Antineoplastic Agents, Hormonal Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents |