Trials / Completed
CompletedNCT00035594
Pegfilgrastim as Support to Advanced Breast Cancer Patients Receiving Chemotherapy
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 928 (planned)
- Sponsor
- Amgen · Industry
- Sex
- —
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pegfilgrastim | Growth factor (GCSF) administered to promote neutrophil development post-chemotherapy. |
Timeline
- Start date
- 2002-02-01
- Primary completion
- 2004-02-01
- Completion
- 2004-06-01
- First posted
- 2002-05-06
- Last updated
- 2013-05-09
Source: ClinicalTrials.gov record NCT00035594. Inclusion in this directory is not an endorsement.