At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 334 enrolled

Drug / intervention

Balugrastim +2 morebiological

Likely dose

Chemotherapy Regimen 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.

Search/NCT00837265

NCT00837265Phase 3Completed

Compare CT.gov

A Randomized 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)

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Feb 5, 2009·Updated Apr 3, 2024

In Brief

A Phase 3 clinical trial evaluating Balugrastim, Pegfilgrastim, and 1 other intervention for Chemotherapy-induced Neutropenia. Completed, enrolled 334 participants.

Detailed Summary

Determination of the effect of balugrastim on the duration and severity of severe neutropenia.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsChemotherapy-induced Neutropenia

Countries--

Collaborators--

Timeline

Phase 3CompletedFinished

200920102011201220132014201520162017201820192020202120222023202420252026

Enrollment StartAug 2008

First PostedFeb 2009

Primary CompletionJun 2009

TodayJul 2026

First PostedFeb 5, 2009

Enrollment StartAug 21, 2008

Primary CompletionJun 26, 2009

TodayJul 2, 2026

Enrollment to primary: 10 monthsPosted 17.4 years ago

Interventions

Balugrastimbiological

Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description.

Pegfilgrastimdrug

Pegfilgrastim will be administered per dose and schedule specified in the arm description.

Chemotherapy Regimendrug

The chemotherapy regimen consisting of doxorubicin 60 mg/square meter (m\^2) and docetaxel 75 mg/m\^2 will be administered sequentially by intravenous (IV) infusion on Day 1 of treatment for up to four 21-day cycles.