Combination Chemotherapy With or Without Darbepoetin Alfa in Treating Women With Stage III Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00309920
- Lead Sponsor
- Heinrich-Heine University, Duesseldorf
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 1234
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival at 6 months to 5 years after treatment
- Secondary Outcome Measures
Name Time Method Overall survival at 6 months to 5 years after treatment Toxicity by NCI toxicity criteria at every course and periodically thereafter Anemia and cognitive function by Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) at every course Local relapses at 6 months to 5 years after treatment
Trial Locations
- Locations (47)
Knappschaft Krankenhaus
🇩🇪Bochum-Langendreer, Germany
Praxis Fuer Haematologie Internistische Onkologie
🇩🇪Cologne, Germany
St. Elisabeth-Krankenhaus - Koeln
🇩🇪Cologne, Germany
Universitaetsklinikum Duesseldorf
🇩🇪Duesseldorf, Germany
St. Marien Hospital - Luenen
🇩🇪Luenen, Germany
Evangelisches Krankenhaus Oberhausen
🇩🇪Oberhausen, Germany
Universitaetsklinikum des Saarlandes
🇩🇪Homburg, Germany
Haematologie / Onkologische Schwerpunktpraxis
🇩🇪Wuppertal, Germany
Praxis fuer Haematologie und Onkoligie
🇩🇪Rheine, Germany
Internistische Onkologische Praxis - Kronach
🇩🇪Kronach, Germany
Klinikum Suedstadt Rostock
🇩🇪Rostock, Germany
Staedtisches Klinikum Solingen
🇩🇪Solingen, Germany
Katherinen-Hospital gGmbH
🇩🇪Unna, Germany
Marien-Hospital Wesel gGmbH
🇩🇪Wesel, Germany
Internistische Gemeinschaftspraxis - Offenbach
🇩🇪Offenbach, Germany
Marien-Hospital Witten
🇩🇪Witten, Germany
Bethesda Krankenhaus Wuppertal gGmbH
🇩🇪Wuppertal, Germany
Kreiskrankenhaus Aurich
🇩🇪Aurich, Germany
Praxis fuer Haematologie - Onkologie
🇩🇪Bonn-Duisdorf, Germany
Evangelisches Krankenhaus - Bergisch Gladbach
🇩🇪Bergisch, Germany
Johanniter-Krankenhaus Bonn
🇩🇪Bonn, Germany
Medizinische Universitaetsklinik I at the University of Cologne
🇩🇪Cologne, Germany
Onkologische Schwerpunktpraxis
🇩🇪Duisburg, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Allgemeines Krankenhaus Hagen
🇩🇪Hagen, Germany
Evangelisches Krankenhaus Hagen-Haspe GmbH
🇩🇪Hagen, Germany
Henriettenstiftung Krankenhaus
🇩🇪Hannover, Germany
II Medizinische Klinik - Klinikum Fuerth
🇩🇪Fuerth, Germany
Praxisgemeinschaft fuer Gynaekologische Onkologie
🇩🇪Hildesheim, Germany
Klinikum Minden
🇩🇪Minden, Germany
Krankenhaus Bethanien
🇩🇪Moers, Germany
Onkologische Gemeinschaftspraxis
🇩🇪Bonn, Germany
St. Rochus Hospital
🇩🇪Castrop-Rauxel, Germany
Wilhelm-Anton-Hospital gGmbH, Goch
🇩🇪Goch, Germany
Marienkrankenhaus Schwerte gem. GmbH
🇩🇪Schwerte, Germany
Evangelische Kliniken Gelsenkirchen GmbH
🇩🇪Gelsenkirchen, Germany
Maria-Josef-Hospital Greven GmbH
🇩🇪Greven, Germany
Frankenwald Klinik
🇩🇪Kronach, Germany
Maria-Hilf-Krankenhaus
🇩🇪Bergheim, Germany
Klinikum Deggendorf
🇩🇪Deggendorf, Germany
St. Vincenz und Elisabeth Hospital
🇩🇪Mainz, Germany
Klinikum Memmingen
🇩🇪Memmingen, Germany
Alfried Krupp Krankenhaus
🇩🇪Essen, Germany
Klinikum Kaufbeuren Ostallgaeu
🇩🇪Kaufbeuren, Germany
Katholisches Klinikum Koblenz Marienhof
🇩🇪Koblenz, Germany
Marienhaus Klinikum St. Elisabeth Neuwied
🇩🇪Neuwied, Germany
Praxis Fuer Internistische Haematologie / Onkologie
🇩🇪Troisdorf, Germany