Neutropenia
Conditions
Keywords
Breast cancer, Neutropenia, Chemotherapy
Brief 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.
Interventions
DRUGpegfilgrastim
Growth factor (GCSF) administered to promote neutrophil development post-chemotherapy.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Healthy volunteers
No
Inclusion criteria
* Advanced breast cancer * 18 years of age or older * Patients who will be receiving Taxotere (docetaxel) chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects developing febrile neutropenia | Through 4 cycles |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of hospitalization and IV antiinfective use associated with FN; also chemotherapy planned dose on time | Through 4 cycles |
Outcome results
None listed