NCT00117910

Brief Summary

This open-label, multicenter study explored primary and secondary prophylaxis treatment with a single, fixed-dose, subcutaneous (SC) injection of pegfilgrastim in elderly subjects with high-risk breast cancer receiving myelosuppressive chemotherapy. The primary objective was to provide preliminary information on the incidence of protocol defined neutropenic events in chemotherapy cycle 1.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2002

Shorter than P25 for phase_3 breast-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 11, 2005

Completed
Last Updated

May 16, 2008

Status Verified

May 1, 2008

First QC Date

June 30, 2005

Last Update Submit

May 15, 2008

Conditions

Breast Cancer

Keywords

Aged, Granulocyte Colony-Stimulating FactorCombined Modality Therapy, Neutropeniapegfilgrastim, Neulasta®FEC-100, Antineoplastic AgentsBreast Cancer, Female

Outcome Measures

Primary Outcomes (1)

  • Provide preliminary information on the incidence of protocol defined neutropenic events in chemotherapy cycle 1.

Secondary Outcomes (6)

  • Provide preliminary information on primary and secondary prophylaxis treatment with pegfilgrastim with respect to:

  • Incidence of protocol defined neutropenic events over all cycles

  • Incidence of dose reductions and dose delays of planned chemotherapy due to

  • hematological toxicity

  • Relative dose intensity

  • +1 more secondary outcomes

Interventions

pegfilgrastimDRUG

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Romieu G, Clemens M, Mahlberg R, Fargeot P, Constenla M, Schutte M, Easton V, Skacel T, Bacon P, Brugger W. Pegfilgrastim supports delivery of FEC-100 chemotherapy in elderly patients with high risk breast cancer: a randomized phase 2 trial. Crit Rev Oncol Hematol. 2007 Oct;64(1):64-72. doi: 10.1016/j.critrevonc.2006.12.007. Epub 2007 Feb 20.

    PMID: 17317205RESULT

  • Brugger W, Bacon P, Lawrinson S, Romieu G. Neutrophil recovery in elderly breast cancer patients receiving adjuvant anthracycline-containing chemotherapy with pegfilgrastim support. Crit Rev Oncol Hematol. 2009 Dec;72(3):265-9. doi: 10.1016/j.critrevonc.2009.05.002. Epub 2009 Oct 23.

    PMID: 19596586DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsNeutropenia

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 11, 2005

Study Start

October 1, 2002

Study Completion

May 1, 2004

Last Updated

May 16, 2008

Record last verified: 2008-05