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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Fever, Neutropenia

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Neutropenia

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20020778

NCT ID:

NCT00115414

Start Date:

Completion Date:

Related Keywords:

  • Breast Cancer
  • Fever
  • Neutropenia
  • Neulasta┬«
  • Chemotherapy
  • TAC
  • Amgen
  • Breast Neoplasms
  • Neutropenia

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