Pegfilgrastim as Support to Advanced Breast Cancer Patients Receiving Chemotherapy

Neutropenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035594
• Other study ID #: 20010144
• Status: Completed
• Phase: Phase 3
• First received: May 3, 2002
• Last updated: May 7, 2013
• Start date: February 2002
• Est. completion date: June 2004

Study information

• Verified date: May 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 928
• Est. completion date: June 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

• Advanced breast cancer

• 18 years of age or older

• Patients who will be receiving Taxotere (docetaxel) chemotherapy

Study Design

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Neutropenia

Intervention

Drug:
• pegfilgrastim
Growth factor (GCSF) administered to promote neutrophil development post-chemotherapy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

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, plac — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects developing febrile neutropenia		Through 4 cycles	No
Secondary	Incidence of hospitalization and IV antiinfective use associated with FN; also chemotherapy planned dose on time		Through 4 cycles	No

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling