Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00035594
Status:
COMPLETED
Last Update Posted:
2013-05-09
First Post:
2002-05-03
Brief Title:
Pegfilgrastim as Support to Advanced Breast Cancer Patients Receiving Chemotherapy
Sponsor:
Amgen
Organization:
Amgen
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 bodys 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None