Combination Chemotherapy With or Without Darbepoetin Alfa in Treating Women With Stage III Breast Cancer
February 6, 2009 updated by: Heinrich-Heine University, Duesseldorf
Adjuvant Therapy of Breast Cancer: Impact of Erythropoiesis Stimulating Factors on Event Free Survival High Risk Breast Cancer Treatment
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Interventional
Enrollment (Anticipated)
1234
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aurich, Germany, D-26603
- Recruiting
- Kreiskrankenhaus Aurich
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Contact:
- Contact Person
- Phone Number: 49-41-94-1802
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Bergheim, Germany, D-50126
- Recruiting
- Maria-Hilf-Krankenhaus
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Contact:
- Contact Person
- Phone Number: 49-2271-87-0
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Bergisch, Germany, D-51465
- Recruiting
- Evangelisches Krankenhaus - Bergisch Gladbach
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Contact:
- Contact Person
- Phone Number: 49-2202-122-497
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Bochum-Langendreer, Germany, D-44892
- Recruiting
- Knappschaft Krankenhaus
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Contact:
- Contact Person
- Phone Number: 49-234-299-3300
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Bonn, Germany, D-53113
- Recruiting
- Johanniter-Krankenhaus Bonn
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Contact:
- Contact Person
- Phone Number: 49-228-543-2401
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Bonn, Germany, D-53119
- Recruiting
- Onkologische Gemeinschaftspraxis
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Contact:
- Contact Person
- Phone Number: 49-228-908-1900
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Bonn-Duisdorf, Germany, D-53123
- Recruiting
- Praxis fuer Haematologie - Onkologie
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Contact:
- Contact Person
- Phone Number: 49-228-644-546
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Castrop-Rauxel, Germany, D-44575
- Recruiting
- St. Rochus Hospital
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Contact:
- Contact Person
- Phone Number: 49-2305-294-250
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Cologne, Germany, D-50677
- Recruiting
- Praxis Fuer Haematologie Internistische Onkologie
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Contact:
- Contact Person
- Phone Number: 49-221-931-8220
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Cologne, Germany, D-50924
- Recruiting
- Medizinische Universitaetsklinik I at the University of Cologne
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Contact:
- Contact Person
- Phone Number: 49-221-478-4940
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Cologne, Germany, D-50935
- Recruiting
- St. Elisabeth-Krankenhaus - Koeln
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Contact:
- Contact Person
- Phone Number: 49-221-4677-0-521
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Deggendorf, Germany, D-94469
- Recruiting
- Klinikum Deggendorf
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Contact:
- Contact Person
- Phone Number: 49-991-380-3172
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Duesseldorf, Germany, D-40225
- Recruiting
- Universitaetsklinikum Duesseldorf
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Contact:
- Contact Person
- Phone Number: 49-211-811-7550
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Duisburg, Germany, D-47055
- Recruiting
- Onkologische Schwerpunktpraxis
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Contact:
- Contact Person
- Phone Number: 49-211-811-7550
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Essen, Germany, D-45117
- Recruiting
- Alfried Krupp Krankenhaus
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Contact:
- Contact Person
- Phone Number: 49-201-434-2548
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Essen, Germany, D-45122
- Recruiting
- Universitaetsklinikum Essen
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Contact:
- Contact Person
- Phone Number: 49-201-723-2578
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Fuerth, Germany, D-90766
- Recruiting
- II Medizinische Klinik - Klinikum Fuerth
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Contact:
- Contact Person
- Phone Number: 49-911-976-1474
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Gelsenkirchen, Germany, D-45879
- Recruiting
- Evangelische Kliniken Gelsenkirchen GmbH
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Contact:
- Contact Person
- Phone Number: 49-209-160-1201
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Goch, Germany, D-47574
- Recruiting
- Wilhelm-Anton-Hospital gGmbH, Goch
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Contact:
- Contact Person
- Phone Number: 49-2823-891-105
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Greven, Germany, D-48268
- Recruiting
- Maria-Josef-Hospital Greven GmbH
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Contact:
- Contact Person
- Phone Number: 49-2571-502-203
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Hagen, Germany, D-58095
- Recruiting
- Allgemeines Krankenhaus Hagen
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Contact:
- Contact Person
- Phone Number: 49-2331-201-2622
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Hagen, Germany, D-58135
- Recruiting
- Evangelisches Krankenhaus Hagen-Haspe GmbH
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Contact:
- Contact Person
- Phone Number: 49-2331-476-3825
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Hannover, Germany, D-30171
- Recruiting
- Henriettenstiftung Krankenhaus
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Contact:
- Contact Person
- Phone Number: 49-511-289-3350
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Hildesheim, Germany, D-31134
- Recruiting
- Praxisgemeinschaft fuer Gynaekologische Onkologie
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Contact:
- Contact Person
- Phone Number: 49-5121-590-20
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Homburg, Germany, D-66424
- Recruiting
- Universitaetsklinikum des Saarlandes
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Contact:
- Contact Person
- Phone Number: 49-6841-162-8101
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Kaufbeuren, Germany, D-87600
- Recruiting
- Klinikum Kaufbeuren Ostallgaeu
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Contact:
- Contact Person
- Phone Number: 49-8341-421-001
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Koblenz, Germany, D-56073
- Recruiting
- Katholisches Klinikum Koblenz Marienhof
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Contact:
- Contact Person
- Phone Number: 49-261-496-3101
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Kronach, Germany, D-96317
- Recruiting
- Frankenwald Klinik
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Contact:
- Contact Person
- Phone Number: 49-9261-5977-10
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Kronach, Germany, D-96317
- Recruiting
- Internistische Onkologische Praxis - Kronach
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Contact:
- Contact Person
- Phone Number: 49-9261-624-8161
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Luenen, Germany, D-44534
- Recruiting
- St. Marien Hospital - Luenen
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Contact:
- Contact Person
- Phone Number: 49-2306-772-701
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Mainz, Germany, D-55131
- Recruiting
- St. Vincenz und Elisabeth Hospital
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Contact:
- Contact Person
- Phone Number: 49-6131-575-1400
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Memmingen, Germany, D-87700
- Recruiting
- Klinikum Memmingen
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Contact:
- Contact Person
- Phone Number: 49-8331-702-257
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Minden, Germany, D-32423
- Recruiting
- Klinikum Minden
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Contact:
- Contact Person
- Phone Number: 49-571-801-4101
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Moers, Germany, D-47441
- Recruiting
- Krankenhaus Bethanien
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Contact:
- Contact Person
- Phone Number: 49-2841-200-2600
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Neuwied, Germany, D-56564
- Recruiting
- Marienhaus Klinikum St. Elisabeth Neuwied
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Contact:
- Contact Person
- Phone Number: 49-2631-821-213
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Oberhausen, Germany, D-46004
- Recruiting
- Evangelisches Krankenhaus Oberhausen
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Contact:
- Contact Person
- Phone Number: 49-208-881-00
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Offenbach, Germany, D-63065
- Recruiting
- Internistische Gemeinschaftspraxis - Offenbach
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Contact:
- Contact Person
- Phone Number: 49-69-812-626
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Rheine, Germany, D-48431
- Recruiting
- Praxis fuer Haematologie und Onkoligie
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Contact:
- Contact Person
- Phone Number: 49-5971-914-142
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Rostock, Germany, D-18059
- Recruiting
- Klinikum Suedstadt Rostock
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Contact:
- Contact Person
- Phone Number: 49-381-4401-4590
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Schwerte, Germany, D-58239
- Recruiting
- Marienkrankenhaus Schwerte gem. GmbH
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Contact:
- Contact Person
- Phone Number: 49-2304-109-234
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Solingen, Germany, D-42653
- Recruiting
- Staedtisches Klinikum Solingen
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Contact:
- Contact Person
- Phone Number: 49-212-547-2371
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Troisdorf, Germany, D-53840
- Recruiting
- Praxis Fuer Internistische Haematologie / Onkologie
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Contact:
- Contact Person
- Phone Number: 49-2241-975-422
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Unna, Germany, D-59423
- Recruiting
- Katherinen-Hospital gGmbH
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Contact:
- Contact Person
- Phone Number: 49-2303-100-2842
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Wesel, Germany, D-46483
- Recruiting
- Marien-Hospital Wesel gGmbH
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Contact:
- Contact Person
- Phone Number: 49-281-104-1160
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Witten, Germany, D-58452
- Recruiting
- Marien-Hospital Witten
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Contact:
- Contact Person
- Phone Number: 49-2302-173-1328
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Wuppertal, Germany, D-42109
- Recruiting
- Bethesda Krankenhaus Wuppertal gGmbH
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Contact:
- Contact Person
- Phone Number: 49-202-290-2152
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Wuppertal, Germany, D-42275
- Recruiting
- Haematologie / Onkologische Schwerpunktpraxis
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Contact:
- Contact Person
- Phone Number: 49-202-254-1150
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
DISEASE CHARACTERISTICS:
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Disease-free survival at 6 months to 5 years after treatment
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Secondary Outcome Measures
Outcome Measure |
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Overall survival at 6 months to 5 years after treatment
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Toxicity by NCI toxicity criteria at every course and periodically thereafter
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Anemia and cognitive function by Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) at every course
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Local relapses at 6 months to 5 years after treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Ulrike Nitz, PhD, Heinrich-Heine University, Duesseldorf
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Study Registration Dates
First Submitted
March 29, 2006
First Submitted That Met QC Criteria
March 29, 2006
First Posted (Estimate)
April 3, 2006
Study Record Updates
Last Update Posted (Estimate)
February 9, 2009
Last Update Submitted That Met QC Criteria
February 6, 2009
Last Verified
April 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Hematinics
- Docetaxel
- Cyclophosphamide
- Fluorouracil
- Epirubicin
- Doxorubicin
- Liposomal doxorubicin
- Darbepoetin alfa
Other Study ID Numbers
- CDR0000458037
- WGSG-ARA-PLUS
- AVENTIS-WGSG-ARA-PLUS
- SANOFI-WGSF-ARA-PLUS
- EU-205108
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.