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Same Day Dosing of Pegfilgrastim in Breast Cancer Patients Undergoing Chemotherapy (TAC)

This study has been completed.
Information provided by:
Amgen Identifier:
First received: June 22, 2005
Last updated: July 31, 2008
Last verified: July 2008
The purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when administered on the same day versus the next day of chemotherapy, as measured by the duration of grade 4 neutropenia.

Condition Intervention Phase
Breast Cancer Fever Neutropenia Drug: pegfilgrastim Drug: docetaxel Drug: doxorubicin Drug: cyclophosphamide Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Phase 2 Study Evaluating the Safety of Same Day Versus Next Day Administration of Pegfilgrastim With Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) in Women With Breast Cancer

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Neutropenia

Secondary Outcome Measures:
  • Neutropenia
  • Disease Response
  • Adverse Events


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Inclusion Criteria: - Breast cancer, previously untreated Exclusion Criteria: - Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, antiviral) within 72 hours of chemotherapy - Prior malignancy within the last 5 years, with the exception of surgically cured basal/squamous skin cell carcinoma, ductal carcinoma in situ of the breast and/or carcinoma of the cervix in situ - History of impaired cardiac status (e.g., severe heart disease, cardiomyopathy or congestive heart failure) - Major surgery within 2 weeks prior to randomization - Previous exposure to cytokines within two weeks prior - Concurrent use of other investigational agents
  Contacts and Locations
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Please refer to this study by its identifier: NCT00115414

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00115414     History of Changes
Other Study ID Numbers: 20020778
Study First Received: June 22, 2005
Last Updated: July 31, 2008

Keywords provided by Amgen:

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Leukocyte Disorders
Hematologic Diseases
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on August 18, 2017