Pegfilgrastim as Support to Advanced Breast Cancer Patients Receiving Chemotherapy - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00035594

Purpose

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.

Condition	Intervention	Phase
Neutropenia	Drug: pegfilgrastim	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Fever

Drug Information available for: Docetaxel Granulocyte colony-stimulating factor Pegfilgrastim

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study
Official Title:	A Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Evaluating the Prophylactic Use of Pegfilgrastim on the Incidence of Febrile Neutropenia in Subjects With Advanced Breast Cancer Treated With Single Agent Docetaxel

Further study details as provided by Amgen:

Primary Outcome Measures:

Proportion of subjects developing febrile neutropenia [ Time Frame: Through 4 cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of hospitalization and IV antiinfective use associated with FN; also chemotherapy planned dose on time [ Time Frame: Through 4 cycles ] [ Designated as safety issue: No ]

Estimated Enrollment:	928
Study Start Date:	February 2002
Study Completion Date:	June 2004
Primary Completion Date:	February 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator Breast cancer patients receiving docetaxel chemotherapy and placebo.	Drug: pegfilgrastim Growth factor (GCSF) administered to promote neutrophil development post-chemotherapy.
Pegfilgrastim: Experimental Breast cancer patients receiving docetaxel chemotherapy and pegfilgrastim.	Drug: pegfilgrastim Growth factor (GCSF) administered to promote neutrophil development post-chemotherapy.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Advanced breast cancer
18 years of age or older
Patients who will be receiving Taxotere (docetaxel) chemotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035594

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20010144
Study First Received:	May 3, 2002
Last Updated:	March 6, 2008
ClinicalTrials.gov Identifier:	NCT00035594
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

Breast cancer
Neutropenia
Chemotherapy

Study placed in the following topic categories:

Docetaxel
Fever
Neutropenia
Skin Diseases
Hematologic Diseases
Agranulocytosis

Breast Neoplasms
Leukocyte Disorders
Leukopenia
Granulocytopenia
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009