Pegfilgrastim as Support to Advanced Breast Cancer Patients Receiving Chemotherapy
NCT ID: NCT00035594
Last Updated: 2013-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
928 participants
INTERVENTIONAL
2002-02-28
2004-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Placebo
Breast cancer patients receiving docetaxel chemotherapy and placebo.
pegfilgrastim
Growth factor (GCSF) administered to promote neutrophil development post-chemotherapy.
Pegfilgrastim
Breast cancer patients receiving docetaxel chemotherapy and pegfilgrastim.
pegfilgrastim
Growth factor (GCSF) administered to promote neutrophil development post-chemotherapy.
Interventions
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pegfilgrastim
Growth factor (GCSF) administered to promote neutrophil development post-chemotherapy.
Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older
* Patients who will be receiving Taxotere (docetaxel) chemotherapy
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
References
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Vogel CL, Wojtukiewicz MZ, Carroll RR, Tjulandin SA, Barajas-Figueroa LJ, Wiens BL, Neumann TA, Schwartzberg LS. First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer: a multicenter, double-blind, placebo-controlled phase III study. J Clin Oncol. 2005 Feb 20;23(6):1178-84. doi: 10.1200/JCO.2005.09.102.
Lyman GH, Reiner M, Morrow PK, Crawford J. The effect of filgrastim or pegfilgrastim on survival outcomes of patients with cancer receiving myelosuppressive chemotherapy. Ann Oncol. 2015 Jul;26(7):1452-8. doi: 10.1093/annonc/mdv174. Epub 2015 Apr 7.
Related Links
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AmgenTrials clinical trials website
Notice regarding posted summaries of trial results
To access clinical trial results information click on this link
FDA-approved Drug Labeling
Other Identifiers
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20010144
Identifier Type: -
Identifier Source: org_study_id
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