Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel

Phase 3 Completed 381 enrolled Teva Branded Pharmaceutical Products R&D, Inc.

RandomizedParallel-groupTriple-blindSupportive care

Summary

Determination of the effect of neugranin on the duration and severity of severe neutropenia in participants receiving doxorubicin in combination with docetaxel.

Timeline

Start: 2010-06-30
Primary completion: 2012-02-29
Completion: 2012-02-29

Publications

Volovat C, Gladkov OA, Bondarenko IM, Barash S, Buchner A, Bias P, Adar L, Avisar N. Efficacy and safety of balugrastim compared with pegfilgrastim in patients with breast cancer receiving chemotherapy. Clin Breast Cancer. 2014 Apr;14(2):101-8. doi: 10.1016/j.clbc.2013.10.001. Epub 2013 Oct 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Balugrastim	Protein / enzyme biologic	40 mg	Subcutaneous
Comparator	Pegfilgrastim	Protein / enzyme biologic	6 mg	Subcutaneous
Background	Docetaxel	Small molecule	75 mg/m2	Intravenous
Background	Doxorubicin	Other / unclassified	60 mg/m2	Intravenous

Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel

Summary

Timeline

Publications

Drugs

Indications