Combination Chemotherapy With or Without Darbepoetin Alfa in Treating Women With Stage III Breast Cancer
NCT ID: NCT00309920
Last Updated: 2009-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1234 participants
INTERVENTIONAL
2004-01-31
Brief Summary
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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.
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Detailed Description
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Primary
* Compare the disease-free survival rate in women with stage III breast cancer treated with adjuvant chemotherapy with vs without darbepoetin alfa.
Secondary
* Compare local recurrence and overall survival in patients receiving these regimens.
* Compare toxicity of these regimens in these patients.
* Compare quality of life and fatigue frequency in patients treated with these regimens.
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:
* Regimen CEF: Patients receive cyclophosphamide IV, epirubicin hydrochloride IV, and fluorouracil IV on day 1.
* Regimen TAC: Patients receive docetaxel IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1.
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:
* Regimen CEF: Patients receive regimen CEF as in arm I. Patients receive darbepoetin alfa if hemoglobin falls to ≤ 13.0 g/dL. Darbepoetin alfa is discontinued when hemoglobin rises to \> 14.0 g/dL.
* Regimen TAC: Patients receive TAC as in arm I and darbepoetin alfa as in arm II, regimen CEF.
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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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darbepoetin alfa
cyclophosphamide
docetaxel
doxorubicin hydrochloride
epirubicin hydrochloride
fluorouracil
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed breast cancer
* Stage III disease (pT1, N2-3, M0)
* No metastatic disease by thoracic x-ray, full-body bone scan, and liver sonography
* No inflammatory disease or Paget's disease
* Disease completely resected (R0) and ≥ 10 axillary lymph nodes removed
* Underwent surgery approximately 42 days ago
* At least 9 positive lymph nodes
* No prior sequential mastectomy
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Female
* Menopausal status not specified
* ECOG performance status 0-1
* WBC ≥ 3,500/mm\^3
* Creatinine ≤ 1.4 mg/dL
* Platelet count ≥ 100,000/mm\^3
* Bilirubin ≤ 2.0 mg/dL
* No pre-existing symptomatic peripheral neuropathy
* Not pregnant or nursing
* No hypersensitivity to darbepoetin alfa, epoetin alfa, or any of their components
* No other malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No participation in another clinical study
* No prior therapies that would preclude study participation
18 Years
65 Years
FEMALE
No
Sponsors
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Heinrich-Heine University, Duesseldorf
OTHER
Principal Investigators
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Ulrike Nitz, PhD
Role: STUDY_CHAIR
Heinrich-Heine University, Duesseldorf
Locations
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Kreiskrankenhaus Aurich
Aurich, , Germany
Maria-Hilf-Krankenhaus
Bergheim, , Germany
Evangelisches Krankenhaus - Bergisch Gladbach
Bergisch, , Germany
Johanniter-Krankenhaus Bonn
Bonn, , Germany
Onkologische Gemeinschaftspraxis
Bonn, , Germany
Praxis fuer Haematologie - Onkologie
Bonn-Duisdorf, , Germany
St. Rochus Hospital
Castrop-Rauxel, , Germany
Praxis Fuer Haematologie Internistische Onkologie
Cologne, , Germany
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, , Germany
St. Elisabeth-Krankenhaus - Koeln
Cologne, , Germany
Klinikum Deggendorf
Deggendorf, , Germany
Onkologische Schwerpunktpraxis
Duisburg, , Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, , Germany
Alfried Krupp Krankenhaus
Essen, , Germany
Universitaetsklinikum Essen
Essen, , Germany
II Medizinische Klinik - Klinikum Fuerth
Fürth, , Germany
Evangelische Kliniken Gelsenkirchen GmbH
Gelsenkirchen, , Germany
Wilhelm-Anton-Hospital gGmbH, Goch
Goch, , Germany
Maria-Josef-Hospital Greven GmbH
Greven, , Germany
Allgemeines Krankenhaus Hagen
Hagen, , Germany
Evangelisches Krankenhaus Hagen-Haspe GmbH
Hagen, , Germany
Henriettenstiftung Krankenhaus
Hanover, , Germany
Praxisgemeinschaft fuer Gynaekologische Onkologie
Hildesheim, , Germany
Universitaetsklinikum des Saarlandes
Homburg, , Germany
Klinikum Kaufbeuren Ostallgaeu
Kaufbeuren, , Germany
Katholisches Klinikum Koblenz Marienhof
Koblenz, , Germany
Frankenwald Klinik
Kronach, , Germany
Internistische Onkologische Praxis - Kronach
Kronach, , Germany
Knappschaft Krankenhaus
Langendreer, , Germany
St. Marien Hospital - Luenen
Lünen, , Germany
St. Vincenz und Elisabeth Hospital
Mainz, , Germany
Klinikum Memmingen
Memmingen, , Germany
Klinikum Minden
Minden, , Germany
Krankenhaus Bethanien
Moers, , Germany
Marienhaus Klinikum St. Elisabeth Neuwied
Neuwied, , Germany
Evangelisches Krankenhaus Oberhausen
Oberhausen, , Germany
Internistische Gemeinschaftspraxis - Offenbach
Offenbach, , Germany
Praxis fuer Haematologie und Onkoligie
Rheine, , Germany
Klinikum Suedstadt Rostock
Rostock, , Germany
Marienkrankenhaus Schwerte gem. GmbH
Schwerte, , Germany
Staedtisches Klinikum Solingen
Solingen, , Germany
Praxis Fuer Internistische Haematologie / Onkologie
Troisdorf, , Germany
Katherinen-Hospital gGmbH
Unna, , Germany
Marien-Hospital Wesel gGmbH
Wesel, , Germany
Marien-Hospital Witten
Witten, , Germany
Bethesda Krankenhaus Wuppertal gGmbH
Wuppertal, , Germany
Haematologie / Onkologische Schwerpunktpraxis
Wuppertal, , Germany
Countries
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Facility Contacts
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Other Identifiers
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WGSG-ARA-PLUS
Identifier Type: -
Identifier Source: secondary_id
AVENTIS-WGSG-ARA-PLUS
Identifier Type: -
Identifier Source: secondary_id
SANOFI-WGSF-ARA-PLUS
Identifier Type: -
Identifier Source: secondary_id
EU-205108
Identifier Type: -
Identifier Source: secondary_id
CDR0000458037
Identifier Type: -
Identifier Source: org_study_id
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