Clinical trial NCT01126190: Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chemotherapy-induced Neutropenia
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-19
Enrollment: 381
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: Inclusion Criteria:

* Breast cancer participants scheduled to receive the AT regimen (doxorubicin/ docetaxel)

Exclusion Criteria:

* Participants may have received no more than 1 prior chemotherapy regimen (including adjuvant therapy if given within the last 12 months)

Primary outcomes:
measure: Double-Blind Phase: Duration of Severe Neutropenia in Cycle 1
timeFrame: Cycle 1 (cycle length = 21 days)
measure: Open-Label Phase: Duration of Severe Neutropenia in Cycle 1
timeFrame: Cycle 1 (cycle length = 21 days)
Secondary outcomes:
measure: Double-Blind Phase: Number of Participants With Febrile Neutropenia
timeFrame: Cycles 1-4 (each cycle = 21 days)
measure: Open-Label Phase: Number of Participants With Febrile Neutropenia
timeFrame: Cycles 1-4 (each cycle = 21 days)
Other outcomes:
Locations:
city: Gabrovo
country: Bulgaria
facility: Teva Investigational Site 3502
city: Plovdiv
country: Bulgaria
facility: Teva Investigational Site 3511
city: Ruse
country: Bulgaria
facility: Teva Investigational Site 3504
city: Shumen
country: Bulgaria
facility: Teva Investigational Site 3501
city: Sofia District
country: Bulgaria
facility: Teva Investigational Site 3506
city: Stara Zagora
country: Bulgaria
facility: Teva Investigational Site 3503
city: Varna
country: Bulgaria
facility: Teva Investigational Site 3505
city: Veliko Tarnovo
country: Bulgaria
facility: Teva Investigational Site 3507
city: Baia Mare, Maramures County
country: Romania
facility: Teva Investigational Site 4001
city: Brasov
country: Romania
facility: Teva Investigational Site 4009
city: Bucharest
country: Romania
facility: Teva Investigational Site 4004
city: Cluj Napoca
country: Romania
facility: Teva Investigational Site 4002
city: Cluj-Napoca
country: Romania
facility: Teva Investigational Site 4011
city: Craiova, Dolj County
country: Romania
facility: Teva Investigational Site 4005
city: Lasi County
country: Romania
facility: Teva Investigational Site 4010
city: Timisoara
country: Romania
facility: Teva Investigational Site 4007
city: Arkhangelsk
country: Russian Federation
facility: Teva Investigational Site 0714
city: Chelyabinsk
country: Russian Federation
facility: Teva Investigational Site 0707
city: Ekaterinburg
country: Russian Federation
facility: Teva Investigational Site 0702
city: Ivanovo
country: Russian Federation
facility: Teva Investigational Site 0708
city: Kazan
country: Russian Federation
facility: Teva Investigational Site 0721
city: Krasnodar
country: Russian Federation
facility: Teva Investigational Site 0709
city: Kursk
country: Russian Federation
facility: Teva Investigational Site 0711
city: Leningrad Region
country: Russian Federation
facility: Teva Investigational Site 0713
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 0710
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 0703
city: Nizhny Novgorod
country: Russian Federation
facility: Teva Investigational Site 0716
city: Orel
country: Russian Federation
facility: Teva Investigational Site 0720
city: Pyatigorsk
country: Russian Federation
facility: Teva Investigational Site 0724
city: Rostov-on-Don
country: Russian Federation
facility: Teva Investigational Site 0725
city: Saint Petersburg
country: Russian Federation
facility: Teva Investigational Site 0704
city: Saint Petersburg
country: Russian Federation
facility: Teva Investigational Site 0722
city: Saint Petersburg
country: Russian Federation
facility: Teva Investigational Site 0706
city: Saint Petersburg
country: Russian Federation
facility: Teva Investigational Site 0715
city: Samara
country: Russian Federation
facility: Teva Investigational Site 0712
city: Sochi
country: Russian Federation
facility: Teva Investigational Site 0723
city: Tambov
country: Russian Federation
facility: Teva Investigational Site 0717
city: Ufa
country: Russian Federation
facility: Teva Investigational Site 0719
city: Yaroslavl
country: Russian Federation
facility: Teva Investigational Site 0705
city: Belgrade
country: Serbia
facility: Teva Investigational Site 8102
city: Belgrade
country: Serbia
facility: Teva Investigational Site 8103
city: Kragujevac
country: Serbia
facility: Teva Investigational Site 8104
city: Nis
country: Serbia
facility: Teva Investigational Site 8105
city: Chernihiv
country: Ukraine
facility: Teva Investigational Site 3807
city: Chernivtsi
country: Ukraine
facility: Teva Investigational Site 3805
city: Dnipropetrovsk
country: Ukraine
facility: Teva Investigational Site 3802
city: Donetsk
country: Ukraine
facility: Teva Investigational Site 3811
city: Ivano-Frankivsk
country: Ukraine
facility: Teva Investigational Site 3806
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 3814
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 3804
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 3816
city: Khmelnytskyi
country: Ukraine
facility: Teva Investigational Site 3803
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 3808
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 3817
city: Lviv
country: Ukraine
facility: Teva Investigational Site 3812
city: Mariupol, Donetsk Region
country: Ukraine
facility: Teva Investigational Site 3809
city: Odesa
country: Ukraine
facility: Teva Investigational Site 3801
city: Sumy
country: Ukraine
facility: Teva Investigational Site 3815
city: Uzhhorod
country: Ukraine
facility: Teva Investigational Site 3810
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References:
citation: 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.