drugset / Trial / NCT00035594

Pegfilgrastim as Support to Advanced Breast Cancer Patients Receiving Chemotherapy

NCT00035594

Phase 3 Completed 928 enrolled Amgen
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2002-02
Primary completion
2004-02
Completion
2004-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous

Indications