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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00035594     History of Changes
Other Study ID Numbers: 20010144
Study First Received: May 3, 2002
Last Updated: May 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Breast cancer
Neutropenia
Chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neutropenia
Agranulocytosis
Breast Diseases
Hematologic Diseases
Leukocyte Disorders
Leukopenia
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014