At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 381 enrolled
Drug / intervention
Neugranin +2 morebiological
Likely dose
Chemotherapy 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Active Comparator, Non-Inferiority Study of Subcutaneously Administered Neugranin (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) or Pegfilgrastim in Subjects With Breast Cancer Receiving Myelosuppressive Chemotherapy (Doxorubicin/Docetaxel), Followed by a Single-Arm, Open-Label Phase of Subcutaneously Administered Neugranin
Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted May 19, 2010·Updated Mar 28, 2023
In Brief
A Phase 3 clinical trial evaluating Neugranin, Pegfilgrastim, and 1 other intervention for Chemotherapy-induced Neutropenia. Completed, enrolled 381 participants across 59 sites in 5 countries.
Detailed Summary
Determination of the effect of neugranin on the duration and severity of severe neutropenia in participants receiving doxorubicin in combination with docetaxel.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChemotherapy-induced Neutropenia
CountriesBulgaria, Romania, Russia, Serbia, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2010
Enrollment StartJun 2010
Primary CompletionFeb 2012
TodayJul 2026
First PostedMay 19, 2010
Enrollment StartJun 30, 2010
Primary CompletionFeb 29, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.1 years ago
Interventions
Neugraninbiological
Neugranin will be administered per dose and schedule specified in the arm description.
Pegfilgrastimbiological
Pegfilgrastim will be administered per dose and schedule specified in the arm description.
Chemotherapydrug
The chemotherapy regimen for this trial consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 in combination