Pegfilgrastim as Support to Advanced Breast Cancer Patients Receiving Chemotherapy
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neutropenia |
Drug: pegfilgrastim |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | 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 |
- Proportion of subjects developing febrile neutropenia [ Time Frame: Through 4 cycles ] [ Designated as safety issue: No ]
- Incidence of hospitalization and IV antiinfective use associated with FN; also chemotherapy planned dose on time [ Time Frame: Through 4 cycles ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 928 |
| Study Start Date: | February 2002 |
| Study Completion Date: | June 2004 |
| Primary Completion Date: | February 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Breast cancer patients receiving docetaxel chemotherapy and placebo.
|
Drug: pegfilgrastim
Growth factor (GCSF) administered to promote neutrophil development post-chemotherapy.
Other Name: pegfilgrastim
|
|
Experimental: Pegfilgrastim
Breast cancer patients receiving docetaxel chemotherapy and pegfilgrastim.
|
Drug: pegfilgrastim
Growth factor (GCSF) administered to promote neutrophil development post-chemotherapy.
Other Name: pegfilgrastim
|
Eligibility| Accepts Healthy Volunteers: | No |
- Advanced breast cancer
- 18 years of age or older
- Patients who will be receiving Taxotere (docetaxel) chemotherapy
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00035594 History of Changes |
| Other Study ID Numbers: | 20010144 |
| Study First Received: | May 3, 2002 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amgen:
|
Breast cancer Neutropenia Chemotherapy |
Additional relevant MeSH terms:
|
Breast Neoplasms Neutropenia Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013