Combination Chemotherapy With or Without Darbepoetin Alfa in Treating Women With Stage III Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00309920
First received: March 29, 2006
Last updated: February 6, 2009
Last verified: April 2006
  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
Biological: darbepoetin alfa
Drug: cyclophosphamide
Drug: docetaxel
Drug: doxorubicin hydrochloride
Drug: epirubicin hydrochloride
Drug: fluorouracil

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adjuvant Therapy of Breast Cancer: Impact of Erythropoiesis Stimulating Factors on Event Free Survival High Risk Breast Cancer Treatment

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Kreiskrankenhaus Aurich Recruiting
Aurich, Germany, D-26603
Contact: Contact Person    49-41-94-1802      
Maria-Hilf-Krankenhaus Recruiting
Bergheim, Germany, D-50126
Contact: Contact Person    49-2271-87-0      
Evangelisches Krankenhaus - Bergisch Gladbach Recruiting
Bergisch, Germany, D-51465
Contact: Contact Person    49-2202-122-497      
Knappschaft Krankenhaus Recruiting
Bochum-Langendreer, Germany, D-44892
Contact: Contact Person    49-234-299-3300      
Johanniter-Krankenhaus Bonn Recruiting
Bonn, Germany, D-53113
Contact: Contact Person    49-228-543-2401      
Onkologische Gemeinschaftspraxis Recruiting
Bonn, Germany, D-53119
Contact: Contact Person    49-228-908-1900      
Praxis fuer Haematologie - Onkologie Recruiting
Bonn-Duisdorf, Germany, D-53123
Contact: Contact Person    49-228-644-546      
St. Rochus Hospital Recruiting
Castrop-Rauxel, Germany, D-44575
Contact: Contact Person    49-2305-294-250      
Medizinische Universitaetsklinik I at the University of Cologne Recruiting
Cologne, Germany, D-50924
Contact: Contact Person    49-221-478-4940      
Praxis Fuer Haematologie Internistische Onkologie Recruiting
Cologne, Germany, D-50677
Contact: Contact Person    49-221-931-8220      
St. Elisabeth-Krankenhaus - Koeln Recruiting
Cologne, Germany, D-50935
Contact: Contact Person    49-221-4677-0-521      
Klinikum Deggendorf Recruiting
Deggendorf, Germany, D-94469
Contact: Contact Person    49-991-380-3172      
Universitaetsklinikum Duesseldorf Recruiting
Duesseldorf, Germany, D-40225
Contact: Contact Person    49-211-811-7550      
Onkologische Schwerpunktpraxis Recruiting
Duisburg, Germany, D-47055
Contact: Contact Person    49-211-811-7550      
Universitaetsklinikum Essen Recruiting
Essen, Germany, D-45122
Contact: Contact Person    49-201-723-2578      
Alfried Krupp Krankenhaus Recruiting
Essen, Germany, D-45117
Contact: Contact Person    49-201-434-2548      
II Medizinische Klinik - Klinikum Fuerth Recruiting
Fuerth, Germany, D-90766
Contact: Contact Person    49-911-976-1474      
Evangelische Kliniken Gelsenkirchen GmbH Recruiting
Gelsenkirchen, Germany, D-45879
Contact: Contact Person    49-209-160-1201      
Wilhelm-Anton-Hospital gGmbH, Goch Recruiting
Goch, Germany, D-47574
Contact: Contact Person    49-2823-891-105      
Maria-Josef-Hospital Greven GmbH Recruiting
Greven, Germany, D-48268
Contact: Contact Person    49-2571-502-203      
Evangelisches Krankenhaus Hagen-Haspe GmbH Recruiting
Hagen, Germany, D-58135
Contact: Contact Person    49-2331-476-3825      
Allgemeines Krankenhaus Hagen Recruiting
Hagen, Germany, D-58095
Contact: Contact Person    49-2331-201-2622      
Henriettenstiftung Krankenhaus Recruiting
Hannover, Germany, D-30171
Contact: Contact Person    49-511-289-3350      
Praxisgemeinschaft fuer Gynaekologische Onkologie Recruiting
Hildesheim, Germany, D-31134
Contact: Contact Person    49-5121-590-20      
Universitaetsklinikum des Saarlandes Recruiting
Homburg, Germany, D-66424
Contact: Contact Person    49-6841-162-8101      
Klinikum Kaufbeuren Ostallgaeu Recruiting
Kaufbeuren, Germany, D-87600
Contact: Contact Person    49-8341-421-001      
Katholisches Klinikum Koblenz Marienhof Recruiting
Koblenz, Germany, D-56073
Contact: Contact Person    49-261-496-3101      
Frankenwald Klinik Recruiting
Kronach, Germany, D-96317
Contact: Contact Person    49-9261-5977-10      
Internistische Onkologische Praxis - Kronach Recruiting
Kronach, Germany, D-96317
Contact: Contact Person    49-9261-624-8161      
St. Marien Hospital - Luenen Recruiting
Luenen, Germany, D-44534
Contact: Contact Person    49-2306-772-701      
St. Vincenz und Elisabeth Hospital Recruiting
Mainz, Germany, D-55131
Contact: Contact Person    49-6131-575-1400      
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      
Krankenhaus Bethanien Recruiting
Moers, Germany, D-47441
Contact: Contact Person    49-2841-200-2600      
Marienhaus Klinikum St. Elisabeth Neuwied Recruiting
Neuwied, Germany, D-56564
Contact: Contact Person    49-2631-821-213      
Evangelisches Krankenhaus Oberhausen Recruiting
Oberhausen, Germany, D-46004
Contact: Contact Person    49-208-881-00      
Internistische Gemeinschaftspraxis - Offenbach Recruiting
Offenbach, Germany, D-63065
Contact: Contact Person    49-69-812-626      
Praxis fuer Haematologie und Onkoligie Recruiting
Rheine, Germany, D-48431
Contact: Contact Person    49-5971-914-142      
Klinikum Suedstadt Rostock Recruiting
Rostock, Germany, D-18059
Contact: Contact Person    49-381-4401-4590      
Marienkrankenhaus Schwerte gem. GmbH Recruiting
Schwerte, Germany, D-58239
Contact: Contact Person    49-2304-109-234      
Staedtisches Klinikum Solingen Recruiting
Solingen, Germany, D-42653
Contact: Contact Person    49-212-547-2371      
Praxis Fuer Internistische Haematologie / Onkologie Recruiting
Troisdorf, Germany, D-53840
Contact: Contact Person    49-2241-975-422      
Katherinen-Hospital gGmbH Recruiting
Unna, Germany, D-59423
Contact: Contact Person    49-2303-100-2842      
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      
Bethesda Krankenhaus Wuppertal gGmbH Recruiting
Wuppertal, Germany, D-42109
Contact: Contact Person    49-202-290-2152      
Haematologie / Onkologische Schwerpunktpraxis Recruiting
Wuppertal, Germany, D-42275
Contact: Contact Person    49-202-254-1150      
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
Study Chair: Ulrike Nitz, PhD Heinrich-Heine University, Duesseldorf
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00309920     History of Changes
Other 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: February 6, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IIIA breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Docetaxel
Doxorubicin
Epirubicin
Darbepoetin alfa
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Hematinics
Hematologic Agents

ClinicalTrials.gov processed this record on July 24, 2014