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Balugrastim (Neugranin) in Breast Cancer Participants Receiving Doxorubicin/Docetaxel

NCT00837265 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2024-04-03

Study results available
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Summary

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

Conditions

  • Chemotherapy-induced Neutropenia

Interventions

BIOLOGICAL

Balugrastim

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

DRUG

Pegfilgrastim

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

DRUG

Chemotherapy Regimen

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.

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-21
Primary Completion
2009-06-26
Completion
2009-06-26

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00837265 on ClinicalTrials.gov