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Sponsored by: |
Heinrich-Heine University, Duesseldorf |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00309920 |
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Colony-stimulating factors, such as darbepoetin alfa, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with darbepoetin alfa after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy and darbepoetin alfa are more effective than combination chemotherapy alone in treating stage III breast cancer.
PURPOSE: This randomized clinical trial is studying how well giving combination chemotherapy together with darbepoetin alfa works compared to combination chemotherapy alone in treating women with stage III breast cancer.
Condition | Intervention |
---|---|
Breast Cancer |
Drug: cyclophosphamide Drug: darbepoetin alfa Drug: docetaxel Drug: doxorubicin hydrochloride Drug: epirubicin hydrochloride Drug: fluorouracil |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | Adjuvant Therapy of Breast Cancer: Impact of Erythropoiesis Stimulating Factors on Event Free Survival High Risk Breast Cancer Treatment |
Estimated Enrollment: | 1234 |
Study Start Date: | January 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according the chemotherapy regimen (CEF vs TAC). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive 1 of the following regimens:
Treatment repeats every 3 weeks for 6 courses in the absence of disease progression and unacceptable toxicity.
Arm II: Patients receive 1 of the following regimens:
Quality of life is assessed at baseline, before each chemotherapy course, at the completion of study therapy, and at 6 and 12 months.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 1,234 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Disease completely resected (R0) and ≥ 10 axillary lymph nodes removed
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Germany | |
Alfried Krupp Krankenhaus | Recruiting |
Essen, Germany, D-45117 | |
Contact: Contact Person 49-201-434-2548 | |
Allgemeines Krankenhaus Hagen | Recruiting |
Hagen, Germany, D-58095 | |
Contact: Contact Person 49-2331-201-2622 | |
Bethesda Krankenhaus Wuppertal gGmbH | Recruiting |
Wuppertal, Germany, D-42109 | |
Contact: Contact Person 49-202-290-2152 | |
Evangelische Kliniken Gelsenkirchen GmbH | Recruiting |
Gelsenkirchen, Germany, D-45879 | |
Contact: Contact Person 49-209-160-1201 | |
Evangelisches Krankenhaus - Bergisch Gladbach | Recruiting |
Bergisch, Germany, D-51465 | |
Contact: Contact Person 49-2202-122-497 | |
Evangelisches Krankenhaus Hagen-Haspe GmbH | Recruiting |
Hagen, Germany, D-58135 | |
Contact: Contact Person 49-2331-476-3825 | |
Evangelisches Krankenhaus Oberhausen | Recruiting |
Oberhausen, Germany, D-46004 | |
Contact: Contact Person 49-208-881-00 | |
Frankenwald Klinik | Recruiting |
Kronach, Germany, D-96317 | |
Contact: Contact Person 49-9261-5977-10 | |
Frauenklinik - Universitaetsklinikum Rostock am Klinikum Sudstadt | Recruiting |
Rostock, Germany, D-18059 | |
Contact: Contact Person 49-381-4401-4590 | |
Haematologie / Onkologische Schwerpunktpraxis | Recruiting |
Wuppertal, Germany, D-42275 | |
Contact: Contact Person 49-202-254-1150 | |
Henriettenstiftung Krankenhaus | Recruiting |
Hannover, Germany, D-30171 | |
Contact: Contact Person 49-511-289-3350 | |
II Medizinische Klinik - Klinikum Fuerth | Recruiting |
Fuerth, Germany, D-90766 | |
Contact: Contact Person 49-911-976-1474 | |
Internistische Gemeinschaftspraxis - Offenbach | Recruiting |
Offenbach, Germany, D-63065 | |
Contact: Contact Person 49-69-812-626 | |
Internistische Onkologische Praxis - Kronach | Recruiting |
Kronach, Germany, D-96317 | |
Contact: Contact Person 49-9261-624-8161 | |
Johanniter-Krankenhaus Bonn | Recruiting |
Bonn, Germany, D-53113 | |
Contact: Contact Person 49-228-543-2401 | |
Katherinen-Hospital gGmbH | Recruiting |
Unna, Germany, D-59423 | |
Contact: Contact Person 49-2303-100-2842 | |
Katholisches Klinikum Koblenz Marienhof | Recruiting |
Koblenz, Germany, D-56073 | |
Contact: Contact Person 49-261-496-3101 | |
Klinikum Deggendorf | Recruiting |
Deggendorf, Germany, D-94469 | |
Contact: Contact Person 49-991-380-3172 | |
Klinikum Kaufbeuren Ostallgaeu | Recruiting |
Kaufbeuren, Germany, D-87600 | |
Contact: Contact Person 49-8341-421-001 | |
Klinikum Memmingen | Recruiting |
Memmingen, Germany, D-87700 | |
Contact: Contact Person 49-8331-702-257 | |
Klinikum Minden | Recruiting |
Minden, Germany, D-32423 | |
Contact: Contact Person 49-571-801-4101 | |
Knappschaft Krankenhaus | Recruiting |
Bochum-Langendreer, Germany, D-44892 | |
Contact: Contact Person 49-234-299-3300 | |
Krankenhaus Bethanien | Recruiting |
Moers, Germany, D-47441 | |
Contact: Contact Person 49-2841-200-2600 | |
Wilhelm-Anton-Hospital gGmbH, Goch | Recruiting |
Goch, Germany, D-47574 | |
Contact: Contact Person 49-2823-891-105 | |
Maria-Hilf-Krankenhaus | Recruiting |
Bergheim, Germany, D-50126 | |
Contact: Contact Person 49-2271-87-0 | |
Maria-Josef-Hospital Greven GmbH | Recruiting |
Greven, Germany, D-48268 | |
Contact: Contact Person 49-2571-502-203 | |
Marienhaus Klinikum St. Elisabeth Neuwied | Recruiting |
Neuwied, Germany, D-56564 | |
Contact: Contact Person 49-2631-821-213 | |
Marien-Hospital Wesel gGmbH | Recruiting |
Wesel, Germany, D-46483 | |
Contact: Contact Person 49-281-104-1160 | |
Marien-Hospital Witten | Recruiting |
Witten, Germany, D-58452 | |
Contact: Contact Person 49-2302-173-1328 | |
Marienkrankenhaus Schwerte gem. GmbH | Recruiting |
Schwerte, Germany, D-58239 | |
Contact: Contact Person 49-2304-109-234 | |
Medizinische Universitaetsklinik I at the University of Cologne | Recruiting |
Cologne, Germany, D-50924 | |
Contact: Contact Person 49-221-478-4940 | |
Onkologische Gemeinschaftspraxis | Recruiting |
Bonn, Germany, D-53119 | |
Contact: Contact Person 49-228-908-1900 | |
Onkologische Schwerpunktpraxis | Recruiting |
Duisburg, Germany, D-47055 | |
Contact: Contact Person 49-211-811-7550 | |
Praxis fuer Haematologie - Onkologie | Recruiting |
Bonn-Duisdorf, Germany, D-53123 | |
Contact: Contact Person 49-228-644-546 | |
Praxis Fuer Haematologie Internistische Onkologie | Recruiting |
Cologne, Germany, D-50677 | |
Contact: Contact Person 49-221-931-8220 | |
Praxis fuer Haematologie und Onkoligie | Recruiting |
Rheine, Germany, D-48431 | |
Contact: Contact Person 49-5971-914-142 | |
Praxis Fuer Internistische Haematologie / Onkologie | Recruiting |
Troisdorf, Germany, D-53840 | |
Contact: Contact Person 49-2241-975-422 | |
Praxisgemeinschaft fuer Gynaekologische Onkologie | Recruiting |
Hildesheim, Germany, D-31134 | |
Contact: Contact Person 49-5121-590-20 | |
St. Elisabeth-Krankenhaus - Koeln | Recruiting |
Cologne, Germany, D-50935 | |
Contact: Contact Person 49-221-4677-0-521 | |
St. Marien Hospital - Luenen | Recruiting |
Luenen, Germany, D-44534 | |
Contact: Contact Person 49-2306-772-701 | |
St. Rochus Hospital | Recruiting |
Castrop-Rauxel, Germany, D-44575 | |
Contact: Contact Person 49-2305-294-250 | |
St. Vincenz und Elisabeth Hospital | Recruiting |
Mainz, Germany, D-55131 | |
Contact: Contact Person 49-6131-575-1400 | |
Staedtisches Klinikum Solingen | Recruiting |
Solingen, Germany, D-42653 | |
Contact: Contact Person 49-212-547-2371 | |
Universitaetsklinikum des Saarlandes | Recruiting |
Homburg, Germany, D-66424 | |
Contact: Contact Person 49-6841-162-8101 | |
Universitaetsklinikum Duesseldorf | Recruiting |
Duesseldorf, Germany, D-40225 | |
Contact: Contact Person 49-211-811-7550 | |
Universitaetsklinikum Essen | Recruiting |
Essen, Germany, D-45122 | |
Contact: Contact Person 49-201-723-2578 | |
Kreiskrankenhaus Aurich | Recruiting |
Aurich, Germany, D-26603 | |
Contact: Contact Person 49-41-94-1802 |
Study Chair: | Ulrike Nitz, PhD | Heinrich-Heine University, Duesseldorf |
Study ID Numbers: | CDR0000458037, WGSG-ARA-PLUS, AVENTIS-WGSG-ARA-PLUS, SANOFI-WGSF-ARA-PLUS, EU-205108 |
Study First Received: | March 29, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00309920 |
Health Authority: | Unspecified |
stage IIIA breast cancer stage IIIC breast cancer |
Docetaxel Skin Diseases Fluorouracil Darbepoetin alfa Breast Neoplasms |
Cyclophosphamide Epirubicin Doxorubicin Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Hematinics Antineoplastic Agents Hematologic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |