Back to resultsCombination Chemotherapy With or Without Darbepoetin Alfa in Treating Women With Stage III Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
darbepoetin alfa
cyclophosphamide
docetaxel
doxorubicin hydrochloride
epirubicin hydrochloride
fluorouracil
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage IIIA breast cancer, stage IIIC breast cancer
Eligibility Criteria
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
Sites / Locations
- Kreiskrankenhaus AurichRecruiting
- Maria-Hilf-KrankenhausRecruiting
- Evangelisches Krankenhaus - Bergisch GladbachRecruiting
- Knappschaft KrankenhausRecruiting
- Praxis fuer Haematologie - OnkologieRecruiting
- Johanniter-Krankenhaus BonnRecruiting
- Onkologische GemeinschaftspraxisRecruiting
- St. Rochus HospitalRecruiting
- Praxis Fuer Haematologie Internistische OnkologieRecruiting
- Medizinische Universitaetsklinik I at the University of CologneRecruiting
- St. Elisabeth-Krankenhaus - KoelnRecruiting
- Klinikum DeggendorfRecruiting
- Universitaetsklinikum DuesseldorfRecruiting
- Onkologische SchwerpunktpraxisRecruiting
- Alfried Krupp KrankenhausRecruiting
- Universitaetsklinikum EssenRecruiting
- II Medizinische Klinik - Klinikum FuerthRecruiting
- Evangelische Kliniken Gelsenkirchen GmbHRecruiting
- Wilhelm-Anton-Hospital gGmbH, GochRecruiting
- Maria-Josef-Hospital Greven GmbHRecruiting
- Allgemeines Krankenhaus HagenRecruiting
- Evangelisches Krankenhaus Hagen-Haspe GmbHRecruiting
- Henriettenstiftung KrankenhausRecruiting
- Praxisgemeinschaft fuer Gynaekologische OnkologieRecruiting
- Universitaetsklinikum des SaarlandesRecruiting
- Klinikum Kaufbeuren OstallgaeuRecruiting
- Katholisches Klinikum Koblenz MarienhofRecruiting
- Frankenwald KlinikRecruiting
- Internistische Onkologische Praxis - KronachRecruiting
- St. Marien Hospital - LuenenRecruiting
- St. Vincenz und Elisabeth HospitalRecruiting
- Klinikum MemmingenRecruiting
- Klinikum MindenRecruiting
- Krankenhaus BethanienRecruiting
- Marienhaus Klinikum St. Elisabeth NeuwiedRecruiting
- Evangelisches Krankenhaus OberhausenRecruiting
- Internistische Gemeinschaftspraxis - OffenbachRecruiting
- Praxis fuer Haematologie und OnkoligieRecruiting
- Klinikum Suedstadt RostockRecruiting
- Marienkrankenhaus Schwerte gem. GmbHRecruiting
- Staedtisches Klinikum SolingenRecruiting
- Praxis Fuer Internistische Haematologie / OnkologieRecruiting
- Katherinen-Hospital gGmbHRecruiting
- Marien-Hospital Wesel gGmbHRecruiting
- Marien-Hospital WittenRecruiting
- Bethesda Krankenhaus Wuppertal gGmbHRecruiting
- Haematologie / Onkologische SchwerpunktpraxisRecruiting
Outcomes
Primary Outcome Measures
Disease-free survival at 6 months to 5 years after treatment
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00309920
First Posted
March 29, 2006
Last Updated
February 6, 2009
Sponsor
Heinrich-Heine University, Duesseldorf
1. Study Identification
Unique Protocol Identification Number
NCT00309920
Brief Title
Combination Chemotherapy With or Without Darbepoetin Alfa in Treating Women With Stage III Breast Cancer
Official Title
Adjuvant Therapy of Breast Cancer: Impact of Erythropoiesis Stimulating Factors on Event Free Survival High Risk Breast Cancer Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2006
Overall Recruitment Status
Unknown status
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Heinrich-Heine University, Duesseldorf
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IIIA breast cancer, stage IIIC breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1234 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
darbepoetin alfa
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
epirubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Primary Outcome Measure Information:
Title
Disease-free survival at 6 months to 5 years after treatment
Secondary Outcome Measure Information:
Title
Overall survival at 6 months to 5 years after treatment
Title
Toxicity by NCI toxicity criteria at every course and periodically thereafter
Title
Anemia and cognitive function by Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) at every course
Title
Local relapses at 6 months to 5 years after treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrike Nitz, PhD
Organizational Affiliation
Heinrich-Heine University, Duesseldorf
Official's Role
Study Chair
Facility Information:
Facility Name
Kreiskrankenhaus Aurich
City
Aurich
ZIP/Postal Code
D-26603
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-41-94-1802
Facility Name
Maria-Hilf-Krankenhaus
City
Bergheim
ZIP/Postal Code
D-50126
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-2271-87-0
Facility Name
Evangelisches Krankenhaus - Bergisch Gladbach
City
Bergisch
ZIP/Postal Code
D-51465
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-2202-122-497
Facility Name
Knappschaft Krankenhaus
City
Bochum-Langendreer
ZIP/Postal Code
D-44892
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-234-299-3300
Facility Name
Praxis fuer Haematologie - Onkologie
City
Bonn-Duisdorf
ZIP/Postal Code
D-53123
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-228-644-546
Facility Name
Johanniter-Krankenhaus Bonn
City
Bonn
ZIP/Postal Code
D-53113
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-228-543-2401
Facility Name
Onkologische Gemeinschaftspraxis
City
Bonn
ZIP/Postal Code
D-53119
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-228-908-1900
Facility Name
St. Rochus Hospital
City
Castrop-Rauxel
ZIP/Postal Code
D-44575
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-2305-294-250
Facility Name
Praxis Fuer Haematologie Internistische Onkologie
City
Cologne
ZIP/Postal Code
D-50677
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-221-931-8220
Facility Name
Medizinische Universitaetsklinik I at the University of Cologne
City
Cologne
ZIP/Postal Code
D-50924
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-221-478-4940
Facility Name
St. Elisabeth-Krankenhaus - Koeln
City
Cologne
ZIP/Postal Code
D-50935
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-221-4677-0-521
Facility Name
Klinikum Deggendorf
City
Deggendorf
ZIP/Postal Code
D-94469
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-991-380-3172
Facility Name
Universitaetsklinikum Duesseldorf
City
Duesseldorf
ZIP/Postal Code
D-40225
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-211-811-7550
Facility Name
Onkologische Schwerpunktpraxis
City
Duisburg
ZIP/Postal Code
D-47055
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-211-811-7550
Facility Name
Alfried Krupp Krankenhaus
City
Essen
ZIP/Postal Code
D-45117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-201-434-2548
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
D-45122
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-201-723-2578
Facility Name
II Medizinische Klinik - Klinikum Fuerth
City
Fuerth
ZIP/Postal Code
D-90766
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-911-976-1474
Facility Name
Evangelische Kliniken Gelsenkirchen GmbH
City
Gelsenkirchen
ZIP/Postal Code
D-45879
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-209-160-1201
Facility Name
Wilhelm-Anton-Hospital gGmbH, Goch
City
Goch
ZIP/Postal Code
D-47574
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-2823-891-105
Facility Name
Maria-Josef-Hospital Greven GmbH
City
Greven
ZIP/Postal Code
D-48268
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-2571-502-203
Facility Name
Allgemeines Krankenhaus Hagen
City
Hagen
ZIP/Postal Code
D-58095
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-2331-201-2622
Facility Name
Evangelisches Krankenhaus Hagen-Haspe GmbH
City
Hagen
ZIP/Postal Code
D-58135
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-2331-476-3825
Facility Name
Henriettenstiftung Krankenhaus
City
Hannover
ZIP/Postal Code
D-30171
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-511-289-3350
Facility Name
Praxisgemeinschaft fuer Gynaekologische Onkologie
City
Hildesheim
ZIP/Postal Code
D-31134
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-5121-590-20
Facility Name
Universitaetsklinikum des Saarlandes
City
Homburg
ZIP/Postal Code
D-66424
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-6841-162-8101
Facility Name
Klinikum Kaufbeuren Ostallgaeu
City
Kaufbeuren
ZIP/Postal Code
D-87600
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-8341-421-001
Facility Name
Katholisches Klinikum Koblenz Marienhof
City
Koblenz
ZIP/Postal Code
D-56073
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-261-496-3101
Facility Name
Frankenwald Klinik
City
Kronach
ZIP/Postal Code
D-96317
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-9261-5977-10
Facility Name
Internistische Onkologische Praxis - Kronach
City
Kronach
ZIP/Postal Code
D-96317
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-9261-624-8161
Facility Name
St. Marien Hospital - Luenen
City
Luenen
ZIP/Postal Code
D-44534
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-2306-772-701
Facility Name
St. Vincenz und Elisabeth Hospital
City
Mainz
ZIP/Postal Code
D-55131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-6131-575-1400
Facility Name
Klinikum Memmingen
City
Memmingen
ZIP/Postal Code
D-87700
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-8331-702-257
Facility Name
Klinikum Minden
City
Minden
ZIP/Postal Code
D-32423
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-571-801-4101
Facility Name
Krankenhaus Bethanien
City
Moers
ZIP/Postal Code
D-47441
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-2841-200-2600
Facility Name
Marienhaus Klinikum St. Elisabeth Neuwied
City
Neuwied
ZIP/Postal Code
D-56564
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-2631-821-213
Facility Name
Evangelisches Krankenhaus Oberhausen
City
Oberhausen
ZIP/Postal Code
D-46004
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-208-881-00
Facility Name
Internistische Gemeinschaftspraxis - Offenbach
City
Offenbach
ZIP/Postal Code
D-63065
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-69-812-626
Facility Name
Praxis fuer Haematologie und Onkoligie
City
Rheine
ZIP/Postal Code
D-48431
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-5971-914-142
Facility Name
Klinikum Suedstadt Rostock
City
Rostock
ZIP/Postal Code
D-18059
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-381-4401-4590
Facility Name
Marienkrankenhaus Schwerte gem. GmbH
City
Schwerte
ZIP/Postal Code
D-58239
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-2304-109-234
Facility Name
Staedtisches Klinikum Solingen
City
Solingen
ZIP/Postal Code
D-42653
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-212-547-2371
Facility Name
Praxis Fuer Internistische Haematologie / Onkologie
City
Troisdorf
ZIP/Postal Code
D-53840
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-2241-975-422
Facility Name
Katherinen-Hospital gGmbH
City
Unna
ZIP/Postal Code
D-59423
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-2303-100-2842
Facility Name
Marien-Hospital Wesel gGmbH
City
Wesel
ZIP/Postal Code
D-46483
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-281-104-1160
Facility Name
Marien-Hospital Witten
City
Witten
ZIP/Postal Code
D-58452
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-2302-173-1328
Facility Name
Bethesda Krankenhaus Wuppertal gGmbH
City
Wuppertal
ZIP/Postal Code
D-42109
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-202-290-2152
Facility Name
Haematologie / Onkologische Schwerpunktpraxis
City
Wuppertal
ZIP/Postal Code
D-42275
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
49-202-254-1150
12. IPD Sharing Statement
Learn more about this trial
Combination Chemotherapy With or Without Darbepoetin Alfa in Treating Women With Stage III Breast Cancer
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