Breast Cancer, Fever, Neutropenia
Conditions
Keywords
Neulasta®, Chemotherapy, TAC, 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.
Interventions
DRUGpegfilgrastim
DRUGdocetaxel
DRUGdoxorubicin
DRUGcyclophosphamide
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neutropenia | — |
Secondary
| Measure | Time frame |
|---|---|
| Neutropenia | — |
| Disease Response | — |
| Adverse Events | — |
Outcome results
None listed