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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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   (Adult)
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
Aurich, Germany, D-26603
Maria-Hilf-Krankenhaus
Bergheim, Germany, D-50126
Evangelisches Krankenhaus - Bergisch Gladbach
Bergisch, Germany, D-51465
Knappschaft Krankenhaus
Bochum-Langendreer, Germany, D-44892
Praxis fuer Haematologie - Onkologie
Bonn-Duisdorf, Germany, D-53123
Johanniter-Krankenhaus Bonn
Bonn, Germany, D-53113
Onkologische Gemeinschaftspraxis
Bonn, Germany, D-53119
St. Rochus Hospital
Castrop-Rauxel, Germany, D-44575
Praxis Fuer Haematologie Internistische Onkologie
Cologne, Germany, D-50677
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, Germany, D-50924
St. Elisabeth-Krankenhaus - Koeln
Cologne, Germany, D-50935
Klinikum Deggendorf
Deggendorf, Germany, D-94469
Universitaetsklinikum Duesseldorf
Duesseldorf, Germany, D-40225
Onkologische Schwerpunktpraxis
Duisburg, Germany, D-47055
Alfried Krupp Krankenhaus
Essen, Germany, D-45117
Universitaetsklinikum Essen
Essen, Germany, D-45122
II Medizinische Klinik - Klinikum Fuerth
Fuerth, Germany, D-90766
Evangelische Kliniken Gelsenkirchen GmbH
Gelsenkirchen, Germany, D-45879
Wilhelm-Anton-Hospital gGmbH, Goch
Goch, Germany, D-47574
Maria-Josef-Hospital Greven GmbH
Greven, Germany, D-48268
Allgemeines Krankenhaus Hagen
Hagen, Germany, D-58095
Evangelisches Krankenhaus Hagen-Haspe GmbH
Hagen, Germany, D-58135
Henriettenstiftung Krankenhaus
Hannover, Germany, D-30171
Praxisgemeinschaft fuer Gynaekologische Onkologie
Hildesheim, Germany, D-31134
Universitaetsklinikum des Saarlandes
Homburg, Germany, D-66424
Klinikum Kaufbeuren Ostallgaeu
Kaufbeuren, Germany, D-87600
Katholisches Klinikum Koblenz Marienhof
Koblenz, Germany, D-56073
Frankenwald Klinik
Kronach, Germany, D-96317
Internistische Onkologische Praxis - Kronach
Kronach, Germany, D-96317
St. Marien Hospital - Luenen
Luenen, Germany, D-44534
St. Vincenz und Elisabeth Hospital
Mainz, Germany, D-55131
Klinikum Memmingen
Memmingen, Germany, D-87700
Klinikum Minden
Minden, Germany, D-32423
Krankenhaus Bethanien
Moers, Germany, D-47441
Marienhaus Klinikum St. Elisabeth Neuwied
Neuwied, Germany, D-56564
Evangelisches Krankenhaus Oberhausen
Oberhausen, Germany, D-46004
Internistische Gemeinschaftspraxis - Offenbach
Offenbach, Germany, D-63065
Praxis fuer Haematologie und Onkoligie
Rheine, Germany, D-48431
Klinikum Suedstadt Rostock
Rostock, Germany, D-18059
Marienkrankenhaus Schwerte gem. GmbH
Schwerte, Germany, D-58239
Staedtisches Klinikum Solingen
Solingen, Germany, D-42653
Praxis Fuer Internistische Haematologie / Onkologie
Troisdorf, Germany, D-53840
Katherinen-Hospital gGmbH
Unna, Germany, D-59423
Marien-Hospital Wesel gGmbH
Wesel, Germany, D-46483
Marien-Hospital Witten
Witten, Germany, D-58452
Bethesda Krankenhaus Wuppertal gGmbH
Wuppertal, Germany, D-42109
Haematologie / Onkologische Schwerpunktpraxis
Wuppertal, Germany, D-42275
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
Study Chair: Ulrike Nitz, PhD Heinrich-Heine University, Duesseldorf
  More Information

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
Liposomal doxorubicin
Doxorubicin
Epirubicin
Darbepoetin alfa
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antimetabolites
Antimetabolites, Antineoplastic
Hematinics

ClinicalTrials.gov processed this record on December 09, 2016