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
Phase 3
N/A
N/A
N/A
N/A
Not Enrolling
Both
Neutropenia
Both
Neutropenia
Trial Information
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
Inclusion Criteria
- Advanced breast cancer
- 18 years of age or older
- Patients who will be receiving Taxotere (docetaxel) chemotherapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Outcome Measure:
Proportion of subjects developing febrile neutropenia
Outcome Time Frame:
Through 4 cycles
Safety Issue:
No
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
United States: Food and Drug Administration
Study ID:
20010144
NCT ID:
NCT00035594
Start Date:
February 2002
Completion Date:
June 2004
Related Keywords:
- Neutropenia
- Breast cancer
- Neutropenia
- Chemotherapy
- Breast Neoplasms
- Neutropenia
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