A Randomized, Double-Blind, Active Comparator, Non-Inferiority Study of Neugranin or Pegfilgrastim in Subjects With Breast Cancer Receiving Myelosuppressive Chemotherapy
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Chemotherapy-induced Neutropenia
Both
Chemotherapy-induced Neutropenia
Trial Information
A Randomized, Double-Blind, Active Comparator, Non-Inferiority Study of Neugranin or Pegfilgrastim in Subjects With Breast Cancer Receiving Myelosuppressive Chemotherapy
Inclusion Criteria:
- Breast cancer patients scheduled to receive the AT regimen (doxorubicin/ docetaxel)
Exclusion Criteria:
- Subjects may have received no more than 1 prior chemotherapy regimen (including
adjuvant therapy if given within the last 12 months)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Outcome Measure:
Duration of severe neutropenia
Outcome Time Frame:
3 weeks, cycle 1
Safety Issue:
No
Principal Investigator
Andrew Rankin, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Teva Pharmaceutical Industries
Authority:
United States: Food and Drug Administration
Study ID:
NEUGR-003
NCT ID:
NCT01126190
Start Date:
June 2010
Completion Date:
February 2012
Related Keywords:
- Chemotherapy-Induced Neutropenia
- Breast Neoplasms
- Neutropenia
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