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

NCT00309920 | Unknown

• 5 other identifiers: CDR0000458037WGSG-ARA-PLUSAVENTIS-WGSG-ARA-PLUSSANOFI-WGSF-ARA-PLUSEU-205108
• Study Type: interventional
• Target: 1,234
• Locations: 1 country
• Sites: 47

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.

Conditions

Breast Cancer

Keywords

stage IIIA breast cancer; stage IIIC breast cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival at 6 months to 5 years after treatment

Secondary Outcomes (4)

• 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

Interventions

darbepoetin alfa BIOLOGICAL

cyclophosphamide DRUG

docetaxel DRUG

doxorubicin hydrochloride DRUG

epirubicin hydrochloride DRUG

fluorouracil DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (47)

Kreiskrankenhaus Aurich

Aurich, D-26603, Germany

RECRUITING

Maria-Hilf-Krankenhaus

Bergheim, D-50126, Germany

RECRUITING

Evangelisches Krankenhaus - Bergisch Gladbach

Bergisch, D-51465, Germany

RECRUITING

Johanniter-Krankenhaus Bonn

Bonn, D-53113, Germany

RECRUITING

Onkologische Gemeinschaftspraxis

Bonn, D-53119, Germany

RECRUITING

Praxis fuer Haematologie - Onkologie

Bonn-Duisdorf, D-53123, Germany

RECRUITING

St. Rochus Hospital

Castrop-Rauxel, D-44575, Germany

RECRUITING

Praxis Fuer Haematologie Internistische Onkologie

Cologne, D-50677, Germany

RECRUITING

Medizinische Universitaetsklinik I at the University of Cologne

Cologne, D-50924, Germany

RECRUITING

St. Elisabeth-Krankenhaus - Koeln

Cologne, D-50935, Germany

RECRUITING

Klinikum Deggendorf

Deggendorf, D-94469, Germany

RECRUITING

Onkologische Schwerpunktpraxis

Duisburg, D-47055, Germany

RECRUITING

Universitaetsklinikum Duesseldorf

Düsseldorf, D-40225, Germany

RECRUITING

Alfried Krupp Krankenhaus

Essen, D-45117, Germany

RECRUITING

Universitaetsklinikum Essen

Essen, D-45122, Germany

RECRUITING

II Medizinische Klinik - Klinikum Fuerth

Fürth, D-90766, Germany

RECRUITING

Evangelische Kliniken Gelsenkirchen GmbH

Gelsenkirchen, D-45879, Germany

RECRUITING

Wilhelm-Anton-Hospital gGmbH, Goch

Goch, D-47574, Germany

RECRUITING

Maria-Josef-Hospital Greven GmbH

Greven, D-48268, Germany

RECRUITING

Allgemeines Krankenhaus Hagen

Hagen, D-58095, Germany

RECRUITING

Evangelisches Krankenhaus Hagen-Haspe GmbH

Hagen, D-58135, Germany

RECRUITING

Henriettenstiftung Krankenhaus

Hanover, D-30171, Germany

RECRUITING

Praxisgemeinschaft fuer Gynaekologische Onkologie

Hildesheim, D-31134, Germany

RECRUITING

Universitaetsklinikum des Saarlandes

Homburg, D-66424, Germany

RECRUITING

Klinikum Kaufbeuren Ostallgaeu

Kaufbeuren, D-87600, Germany

RECRUITING

Katholisches Klinikum Koblenz Marienhof

Koblenz, D-56073, Germany

RECRUITING

Frankenwald Klinik

Kronach, D-96317, Germany

RECRUITING

Internistische Onkologische Praxis - Kronach

Kronach, D-96317, Germany

RECRUITING

Knappschaft Krankenhaus

Langendreer, D-44892, Germany

RECRUITING

St. Marien Hospital - Luenen

Lünen, D-44534, Germany

RECRUITING

St. Vincenz und Elisabeth Hospital

Mainz, D-55131, Germany

RECRUITING

Klinikum Memmingen

Memmingen, D-87700, Germany

RECRUITING

Klinikum Minden

Minden, D-32423, Germany

RECRUITING

Krankenhaus Bethanien

Moers, D-47441, Germany

RECRUITING

Marienhaus Klinikum St. Elisabeth Neuwied

Neuwied, D-56564, Germany

RECRUITING

Evangelisches Krankenhaus Oberhausen

Oberhausen, D-46004, Germany

RECRUITING

Internistische Gemeinschaftspraxis - Offenbach

Offenbach, D-63065, Germany

RECRUITING

Praxis fuer Haematologie und Onkoligie

Rheine, D-48431, Germany

RECRUITING

Klinikum Suedstadt Rostock

Rostock, D-18059, Germany

RECRUITING

Marienkrankenhaus Schwerte gem. GmbH

Schwerte, D-58239, Germany

RECRUITING

Staedtisches Klinikum Solingen

Solingen, D-42653, Germany

RECRUITING

Praxis Fuer Internistische Haematologie / Onkologie

Troisdorf, D-53840, Germany

RECRUITING

Katherinen-Hospital gGmbH

Unna, D-59423, Germany

RECRUITING

Marien-Hospital Wesel gGmbH

Wesel, D-46483, Germany

RECRUITING

Marien-Hospital Witten

Witten, D-58452, Germany

RECRUITING

Bethesda Krankenhaus Wuppertal gGmbH

Wuppertal, D-42109, Germany

RECRUITING

Haematologie / Onkologische Schwerpunktpraxis

Wuppertal, D-42275, Germany

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Darbepoetin alfa; Cyclophosphamide; Docetaxel; Doxorubicin; Epirubicin; Fluorouracil

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ulrike Nitz, PhD

  Heinrich-Heine University, Duesseldorf

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 29, 2006
• First Posted: April 3, 2006
• Study Start: January 1, 2004
• Last Updated: February 9, 2009

Record last verified: 2006-04

Locations

DE (47)