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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00035594 |
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 |
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Neutropenia |
Drug: pegfilgrastim |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study |
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 |
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 |
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Placebo: Placebo Comparator
Breast cancer patients receiving docetaxel chemotherapy and placebo.
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Drug: pegfilgrastim
Growth factor (GCSF) administered to promote neutrophil development post-chemotherapy.
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Pegfilgrastim: Experimental
Breast cancer patients receiving docetaxel chemotherapy and pegfilgrastim.
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Drug: pegfilgrastim
Growth factor (GCSF) administered to promote neutrophil development post-chemotherapy.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20010144 |
Study First Received: | May 3, 2002 |
Last Updated: | May 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00035594 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Breast cancer Neutropenia Chemotherapy |
Docetaxel Fever Neutropenia Skin Diseases Hematologic Diseases Agranulocytosis |
Mitogens Breast Neoplasms Leukocyte Disorders Leukopenia Granulocytopenia Breast Diseases |
Neutropenia Neoplasms Neoplasms by Site Skin Diseases Hematologic Diseases |
Agranulocytosis Breast Neoplasms Leukocyte Disorders Leukopenia Breast Diseases |