Same Day Dosing of Pegfilgrastim in Breast Cancer Patients Undergoing Chemotherapy (TAC)

Phase 2

Completed

• Conditions: Breast Cancer; Fever; Neutropenia

• Registration Number: NCT00115414
• Lead Sponsor: Amgen

Brief Summary

The purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when administered on the same day versus the next day of chemotherapy, as measured by the duration of grade 4 neutropenia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-06-22
• Study First Submitted QC: 2005-06-22
• Study First Posted: 2005-06-23
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-31
• Last Update Posted: 2008-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Breast cancer, previously untreated

Exclusion Criteria

• Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, antiviral) within 72 hours of chemotherapy - Prior malignancy within the last 5 years, with the exception of surgically cured basal/squamous skin cell carcinoma, ductal carcinoma in situ of the breast and/or carcinoma of the cervix in situ - History of impaired cardiac status (e.g., severe heart disease, cardiomyopathy or congestive heart failure) - Major surgery within 2 weeks prior to randomization - Previous exposure to cytokines within two weeks prior - Concurrent use of other investigational agents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Neutropenia

Secondary Outcome Measures

Name	Time	Method
Neutropenia
Disease Response
Adverse Events