Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel
NCT ID: NCT01126190
Last Updated: 2023-03-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
381 participants
INTERVENTIONAL
2010-06-30
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Double-Blind Phase: Pegfilgrastim
Participants will receive pegfilgrastim 6 milligrams (mg), administered by subcutaneous (SC) injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consists of doxorubicin 60 mg/square meter (m\^2) and docetaxel 75 mg/m\^2 administered sequentially by intravenous (IV) infusion on Day 1 of treatment for up to four 21-day cycles.
Pegfilgrastim
Pegfilgrastim will be administered per dose and schedule specified in the arm description.
Chemotherapy
The chemotherapy regimen for this trial consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 in combination
Double-Blind Phase: Neugranin 40 mg
Participants will receive neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
Neugranin
Neugranin will be administered per dose and schedule specified in the arm description.
Chemotherapy
The chemotherapy regimen for this trial consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 in combination
Open-Label Phase: Neugranin 40 mg
Participants will receive neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
Neugranin
Neugranin will be administered per dose and schedule specified in the arm description.
Chemotherapy
The chemotherapy regimen for this trial consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 in combination
Interventions
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Neugranin
Neugranin will be administered per dose and schedule specified in the arm description.
Pegfilgrastim
Pegfilgrastim will be administered per dose and schedule specified in the arm description.
Chemotherapy
The chemotherapy regimen for this trial consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 in combination
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Medical Expert, MD
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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Teva Investigational Site 3502
Gabrovo, , Bulgaria
Teva Investigational Site 3511
Plovdiv, , Bulgaria
Teva Investigational Site 3504
Rousse, , Bulgaria
Teva Investigational Site 3501
Shumen, , Bulgaria
Teva Investigational Site 3506
Sofia District, , Bulgaria
Teva Investigational Site 3503
Stara Zagora, , Bulgaria
Teva Investigational Site 3505
Varna, , Bulgaria
Teva Investigational Site 3507
Veliko Tarnovo, , Bulgaria
Teva Investigational Site 4001
Baia Mare, Maramures County, , Romania
Teva Investigational Site 4009
Brasov, , Romania
Teva Investigational Site 4004
Bucharest, , Romania
Teva Investigational Site 4002
Cluj-Napoca, , Romania
Teva Investigational Site 4011
Cluj-Napoca, , Romania
Teva Investigational Site 4005
Craiova, Dolj County, , Romania
Teva Investigational Site 4010
Lasi County, , Romania
Teva Investigational Site 4007
Timișoara, , Romania
Teva Investigational Site 0714
Arkhangelsk, , Russia
Teva Investigational Site 0707
Chelyabinsk, , Russia
Teva Investigational Site 0708
Ivanovo, , Russia
Teva Investigational Site 0721
Kazan', , Russia
Teva Investigational Site 0709
Krasnodar, , Russia
Teva Investigational Site 0711
Kursk, , Russia
Teva Investigational Site 0713
Leningrad Region, , Russia
Teva Investigational Site 0710
Moscow, , Russia
Teva Investigational Site 0703
Moscow, , Russia
Teva Investigational Site 0716
Nizhny Novgorod, , Russia
Teva Investigational Site 0720
Oryol, , Russia
Teva Investigational Site 0724
Pyatigorsk, , Russia
Teva Investigational Site 0725
Rostov-on-Don, , Russia
Teva Investigational Site 0704
Saint Petersburg, , Russia
Teva Investigational Site 0722
Saint Petersburg, , Russia
Teva Investigational Site 0706
Saint Petersburg, , Russia
Teva Investigational Site 0715
Saint Petersburg, , Russia
Teva Investigational Site 0712
Samara, , Russia
Teva Investigational Site 0723
Sochi, , Russia
Teva Investigational Site 0717
Tambov, , Russia
Teva Investigational Site 0719
Ufa, , Russia
Teva Investigational Site 0705
Yaroslavl, , Russia
Teva Investigational Site 0702
Yekaterinburg, , Russia
Teva Investigational Site 8102
Belgrade, , Serbia
Teva Investigational Site 8103
Belgrade, , Serbia
Teva Investigational Site 8104
Kragujevac, , Serbia
Teva Investigational Site 8105
Niš, , Serbia
Teva Investigational Site 3807
Chernihiv, , Ukraine
Teva Investigational Site 3805
Chernivtsi, , Ukraine
Teva Investigational Site 3802
Dnipropetrovsk, , Ukraine
Teva Investigational Site 3811
Donetsk, , Ukraine
Teva Investigational Site 3806
Ivano-Frankivsk, , Ukraine
Teva Investigational Site 3814
Kharkiv, , Ukraine
Teva Investigational Site 3804
Kharkiv, , Ukraine
Teva Investigational Site 3816
Kharkiv, , Ukraine
Teva Investigational Site 3803
Khmelnytskyi, , Ukraine
Teva Investigational Site 3808
Kyiv, , Ukraine
Teva Investigational Site 3817
Kyiv, , Ukraine
Teva Investigational Site 3812
Lviv, , Ukraine
Teva Investigational Site 3809
Mariupol, Donetsk Region, , Ukraine
Teva Investigational Site 3801
Odesa, , Ukraine
Teva Investigational Site 3815
Sumy, , Ukraine
Teva Investigational Site 3810
Uzhhorod, , Ukraine
Countries
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References
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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.
Other Identifiers
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NEUGR-003
Identifier Type: -
Identifier Source: org_study_id
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