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Pegfilgrastim as Support to Advanced Breast Cancer Patients Receiving Chemotherapy

NCT00035594 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 928

Last updated 2013-05-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

pegfilgrastim

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

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2004-02-29
Completion
2004-06-30

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00035594 on ClinicalTrials.gov