NCT00115414

Brief Summary

The purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when administered on the same day versus the next day of chemotherapy, as measured by the duration of grade 4 neutropenia.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2005

Completed
Last Updated

August 1, 2008

Status Verified

July 1, 2008

First QC Date

June 22, 2005

Last Update Submit

July 31, 2008

Conditions

Breast CancerFeverNeutropenia

Keywords

Neulasta®ChemotherapyTACAmgen

Outcome Measures

Primary Outcomes (1)

  • Neutropenia

Secondary Outcomes (3)

  • Neutropenia

  • Disease Response

  • Adverse Events

Interventions

pegfilgrastimDRUG
docetaxelDRUG
doxorubicinDRUG
cyclophosphamideDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Breast NeoplasmsFeverNeutropenia

Interventions

pegfilgrastimDocetaxelDoxorubicinCyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus Compounds

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 22, 2005

First Posted

June 23, 2005

Last Updated

August 1, 2008

Record last verified: 2008-07