NCT00035594

Brief Summary

Physicians are conducting a clinical trial for patients with advanced breast cancer. Breast cancer can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced. Neutrophils are a type of white blood cells that fight infection and are produced in the bone marrow. If the neutrophil count becomes low due to chemotherapy, a potentially serious condition called neutropenia occurs. Neutropenia is serious because it can affect the body's ability to protect against many types of infections. Pegfilgrastim is an investigational drug being evaluated for its potential ability to increase the number of neutrophils. The purpose of this study is to determine the safety and effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in patients with advanced breast cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
928

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2002

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2002

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

May 9, 2013

Status Verified

May 1, 2013

Enrollment Period

2 years

First QC Date

May 3, 2002

Last Update Submit

May 7, 2013

Conditions

Neutropenia

Keywords

Breast cancerNeutropeniaChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects developing febrile neutropenia

    Through 4 cycles

Secondary Outcomes (1)

  • Incidence of hospitalization and IV antiinfective use associated with FN; also chemotherapy planned dose on time

    Through 4 cycles

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Breast cancer patients receiving docetaxel chemotherapy and placebo.

Drug: pegfilgrastim

Pegfilgrastim

EXPERIMENTAL

Breast cancer patients receiving docetaxel chemotherapy and pegfilgrastim.

Drug: pegfilgrastim

Interventions

pegfilgrastimDRUG

Growth factor (GCSF) administered to promote neutrophil development post-chemotherapy.

PegfilgrastimPlacebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* Advanced breast cancer * 18 years of age or older * Patients who will be receiving Taxotere (docetaxel) chemotherapy

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

Sponsors & Collaborators

Related Publications (2)

  • Vogel CL, Wojtukiewicz MZ, Carroll RR, Tjulandin SA, Barajas-Figueroa LJ, Wiens BL, Neumann TA, Schwartzberg LS. First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer: a multicenter, double-blind, placebo-controlled phase III study. J Clin Oncol. 2005 Feb 20;23(6):1178-84. doi: 10.1200/JCO.2005.09.102.

    PMID: 15718314RESULT

  • Lyman GH, Reiner M, Morrow PK, Crawford J. The effect of filgrastim or pegfilgrastim on survival outcomes of patients with cancer receiving myelosuppressive chemotherapy. Ann Oncol. 2015 Jul;26(7):1452-8. doi: 10.1093/annonc/mdv174. Epub 2015 Apr 7.

    PMID: 25851633DERIVED

Related Links

MeSH Terms

Conditions

NeutropeniaBreast Neoplasms

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2002

First Posted

May 6, 2002

Study Start

February 1, 2002

Primary Completion

February 1, 2004

Study Completion

June 1, 2004

Last Updated

May 9, 2013

Record last verified: 2013-05