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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: | NCT00054587 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of chemotherapy plus radiation therapy with or without trastuzumab is more effective in treating breast cancer.
PURPOSE: Randomized phase III trial to compare two different chemotherapy regimens plus radiation therapy with or without trastuzumab in treating women who have breast cancer that has spread to lymph nodes in the axilla (under the arm).
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Biological: trastuzumab Drug: cyclophosphamide Drug: docetaxel Drug: epirubicin hydrochloride Drug: fluorouracil Procedure: adjuvant therapy Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | Randomized And Multicentric Opened Phase III Study Evaluating The Concomitant Administration Of Docetaxel 75MG/M2 and Epirubicine 75MG/M2 Versus FEC 100 In Non Metastatic With Positive Lymphatic Nodes Breast Cancer Subjects, And The Sequential Addition Of Herceptin In (HER2+++) And (HER2++ And FISH+) Subjects |
Study Start Date: | June 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center. Patients are treated in 2 parts.
Part I: Patients are randomized to 1 of 2 treatment arms.
Patients with HER2/neu-positive tumors then proceed to part II. Patients with HER2/neu-negative tumors receive no further treatment.
Patients with hormone (estrogen or progesterone) receptor-positive tumors also receive oral tamoxifen daily beginning after chemotherapy is completed and continuing for 5 years.
Part II: Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 2,600 patients will be accrued for this study within 3 years.
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed nonmetastatic, unilateral adenocarcinoma of the breast
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
France | |
C.H. Bourg En Bresse | |
Bourg En Bresse, France, 01012 | |
Centre de Lutte Contre le Cancer Georges-Francois Leclerc | |
Dijon, France, 21079 | |
Centre Eugene Marquis | |
Rennes, France, 35042 | |
Centre Hospitalier d'Annecy | |
Annecy, France, 74011 Cedex | |
Centre Hospitalier de Lagny | |
Lagny Sur Marne, France, 77405 | |
Centre Hospitalier de Mulhouse | |
Mulhouse, France, 68051 | |
Centre Hospitalier General Andre Boulloche | |
Montbeliard, France, 25209 | |
Centre Hospitalier Regional Metz Thionville | |
Metz, France, 57038 | |
Centre Jean Perrin | |
Clermont-Ferrand, France, 63011 | |
Centre Paul Papin | |
Angers, France, 49036 | |
Centre Paul Strauss | |
Strasbourg, France, 67065 | |
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 | |
Institut Prive de Cancerologie | |
Grenoble, France, 38100 | |
Clinique du Petit Colmouilins | |
Harfleur, France, 76700 | |
Clinique Saint - Pierre | |
Perpignan, France | |
Clinique Sainte Clotilde | |
Sainte Clotilde, France, 97492 | |
CMC Les Ormeaux | |
Le Havre, France, 76600 | |
Hopital Andre Mignot | |
Le Chesnay, France, 78157 | |
Hopital Avicenne | |
Paris, France, 75674 | |
Hopital Intercommunal De Creteil | |
Creteil, France, 94010 | |
Hopitaux Universitaire de Strasbourg | |
Strasbourg, France, 67091 | |
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 Jean Godinot | |
Reims, France, 51056 | |
CHU Poitiers | |
Poitiers, France, 86021 |
Study Chair: | Marc Spielmann, MD | Institut Gustave Roussy |
Study ID Numbers: | CDR0000269909, FRE-FNCLCC-PACS-04/0005, EU-20236 |
Study First Received: | February 5, 2003 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00054587 History of Changes |
Health Authority: | United States: Federal Government |
stage II breast cancer stage IIIA breast cancer |
Antimetabolites Skin Diseases Immunologic Factors Adjuvants, Immunologic Breast Neoplasms Cyclophosphamide Epirubicin Immunosuppressive Agents |
Docetaxel Anti-Bacterial Agents Fluorouracil Trastuzumab Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Cyclophosphamide Antibiotics, Antineoplastic Epirubicin Immunosuppressive Agents |
Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Fluorouracil Myeloablative Agonists Trastuzumab Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |