Pegfilgrastim as Support to Advanced Breast Cancer Patients Receiving Chemotherapy
- Registration Number
- NCT00035594
- Lead Sponsor
- Amgen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Not specified
- Target Recruitment
- 928
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo pegfilgrastim Breast cancer patients receiving docetaxel chemotherapy and placebo. Pegfilgrastim pegfilgrastim Breast cancer patients receiving docetaxel chemotherapy and pegfilgrastim.
- Primary Outcome Measures
Name Time Method Proportion of subjects developing febrile neutropenia Through 4 cycles
- Secondary Outcome Measures
Name Time Method Incidence of hospitalization and IV antiinfective use associated with FN; also chemotherapy planned dose on time Through 4 cycles