Pegfilgrastim as Support to Advanced Breast Cancer Patients Receiving Chemotherapy

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.

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Key information

Conditions

Neutropenia Agranulocytosis Breast Diseases Breast Neoplasms Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pegfilgrastim

Drug

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

Primary outcomes

Proportion of subjects developing febrile neutropenia

Time frame: Through 4 cycles

Secondary outcomes

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

Time frame: Through 4 cycles

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start: 2002
Primary completion: 2004
Study completion: 2004
First posted: May 6, 2002
Registry last updated: May 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed