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Pegfilgrastim as Support to Advanced Breast Cancer Patients Receiving Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00035594
First received: May 3, 2002
Last updated: May 7, 2013
Last verified: May 2013

May 3, 2002
May 7, 2013
February 2002
February 2004   (final data collection date for primary outcome measure)
Proportion of subjects developing febrile neutropenia [ Time Frame: Through 4 cycles ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00035594 on ClinicalTrials.gov Archive Site
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 ]
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Pegfilgrastim as Support to Advanced Breast Cancer Patients Receiving Chemotherapy
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Neutropenia
Drug: pegfilgrastim
Growth factor (GCSF) administered to promote neutrophil development post-chemotherapy.
Other Name: pegfilgrastim
  • Placebo Comparator: Placebo
    Breast cancer patients receiving docetaxel chemotherapy and placebo.
    Intervention: Drug: pegfilgrastim
  • Experimental: Pegfilgrastim
    Breast cancer patients receiving docetaxel chemotherapy and pegfilgrastim.
    Intervention: Drug: pegfilgrastim
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
928
June 2004
February 2004   (final data collection date for primary outcome measure)
  • Advanced breast cancer
  • 18 years of age or older
  • Patients who will be receiving Taxotere (docetaxel) chemotherapy
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00035594
20010144
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP