Combination Chemotherapy With or Without Darbepoetin Alfa in Treating Women With Stage III Breast Cancer - Full Text View

Sponsored by:	Heinrich-Heine University, Duesseldorf
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00309920

Purpose

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

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Docetaxel Fluorouracil Epirubicin hydrochloride Epirubicin Darbepoetin alfa

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease-free survival at 6 months to 5 years after treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival at 6 months to 5 years after treatment [ Designated as safety issue: No ]
Toxicity by NCI toxicity criteria at every course and periodically thereafter [ Designated as safety issue: Yes ]
Anemia and cognitive function by Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) at every course [ Designated as safety issue: No ]
Local relapses at 6 months to 5 years after treatment [ Designated as safety issue: No ]

Estimated Enrollment:	1234
Study Start Date:	January 2004

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309920

Locations

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

Sponsors and Collaborators

Heinrich-Heine University, Duesseldorf

Investigators

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