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Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel (NEUGR-003)

Primary Purpose

Chemotherapy-induced Neutropenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Neugranin
Pegfilgrastim
Chemotherapy
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chemotherapy-induced Neutropenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Breast cancer patients scheduled to receive the AT regimen (doxorubicin/ docetaxel)

Exclusion Criteria:

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

Sites / Locations

  • Teva Investigational Site 3502
  • Teva Investigational Site 3511
  • Teva Investigational Site 3504
  • Teva Investigational Site 3501
  • Teva Investigational Site 3506
  • Teva Investigational Site 3503
  • Teva Investigational Site 3505
  • Teva Investigational Site 3507
  • Teva Investigational Site 4001
  • Teva Investigational Site 4009
  • Teva Investigational Site 4004
  • Teva Investigational Site 4002
  • Teva Investigational Site 4011
  • Teva Investigational Site 4005
  • Teva Investigational Site 4010
  • Teva Investigational Site 4007
  • Teva Investigational Site 0714
  • Teva Investigational Site 0707
  • Teva Investigational Site 0702
  • Teva Investigational Site 0708
  • Teva Investigational Site 0721
  • Teva Investigational Site 0709
  • Teva Investigational Site 0711
  • Teva Investigational Site 0713
  • Teva Investigational Site 0710
  • Teva Investigational Site 0703
  • Teva Investigational Site 0716
  • Teva Investigational Site 0720
  • Teva Investigational Site 0724
  • Teva Investigational Site 0725
  • Teva Investigational Site 0704
  • Teva Investigational Site 0722
  • Teva Investigational Site 0706
  • Teva Investigational Site 0715
  • Teva Investigational Site 0712
  • Teva Investigational Site 0723
  • Teva Investigational Site 0717
  • Teva Investigational Site 0719
  • Teva Investigational Site 0705
  • Teva Investigational Site 8102
  • Teva Investigational Site 8103
  • Teva Investigational Site 8104
  • Teva Investigational Site 8105
  • Teva Investigational Site 3807
  • Teva Investigational Site 3805
  • Teva Investigational Site 3802
  • Teva Investigational Site 3811
  • Teva Investigational Site 3806
  • Teva Investigational Site 3814
  • Teva Investigational Site 3804
  • Teva Investigational Site 3816
  • Teva Investigational Site 3803
  • Teva Investigational Site 3808
  • Teva Investigational Site 3817
  • Teva Investigational Site 3812
  • Teva Investigational Site 3809
  • Teva Investigational Site 3801
  • Teva Investigational Site 3815
  • Teva Investigational Site 3810

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Double-Blind Phase: Pegfilgrastim

Double-Blind Phase: Neugranin 40 mg

Open-Label Phase: Neugranin 40 mg

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Double-Blind Phase: Duration of Severe Neutropenia in Cycle 1
Severe neutropenia was defined as Grade 4 neutropenia (absolute neutrophil count [ANC] <0.5 x 10^9/liter [L]). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10^9/L within the cycle.
Open-Label Phase: Duration of Severe Neutropenia in Cycle 1
Severe neutropenia was defined as Grade 4 neutropenia (ANC <0.5 x 10^9/L). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10^9/L within the cycle. There was no planned statistical analysis for the open-label phase arm.

Secondary Outcome Measures

Double-Blind Phase: Number of Participants With Febrile Neutropenia
Febrile neutropenia was defined as an imputed or observed ANC <0.5 x 10^9/L and body temperature >38.5 degrees celsius (°C) occurring on the same day and for more than one hour (axillary measurement). Number of participants with febrile neutropenia over all cycles (Cycles 1 to 4) has been reported.
Open-Label Phase: Number of Participants With Febrile Neutropenia
Febrile neutropenia was defined as an imputed or observed ANC <0.5 x 10^9/L and body temperature >38.5 °C occurring on the same day and for more than one hour (axillary measurement). Number of participants with febrile neutropenia over all cycles (Cycles 1 to 4) has been reported.

Full Information

First Posted
May 4, 2010
Last Updated
February 28, 2023
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01126190
Brief Title
Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel
Acronym
NEUGR-003
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 30, 2010 (Actual)
Primary Completion Date
February 29, 2012 (Actual)
Study Completion Date
February 29, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Neutropenia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
381 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Double-Blind Phase: Pegfilgrastim
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Double-Blind Phase: Neugranin 40 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Open-Label Phase: Neugranin 40 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Neugranin
Other Intervention Name(s)
Balugrastim
Intervention Description
Neugranin will be administered per dose and schedule specified in the arm description.
Intervention Type
Biological
Intervention Name(s)
Pegfilgrastim
Other Intervention Name(s)
Neulasta
Intervention Description
Pegfilgrastim will be administered per dose and schedule specified in the arm description.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
Doxorubicin/Docetaxel
Intervention Description
The chemotherapy regimen for this trial consists of doxorubicin 60 mg/m^2 and docetaxel 75 mg/m^2 in combination
Primary Outcome Measure Information:
Title
Double-Blind Phase: Duration of Severe Neutropenia in Cycle 1
Description
Severe neutropenia was defined as Grade 4 neutropenia (absolute neutrophil count [ANC] <0.5 x 10^9/liter [L]). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10^9/L within the cycle.
Time Frame
Cycle 1 (cycle length = 21 days)
Title
Open-Label Phase: Duration of Severe Neutropenia in Cycle 1
Description
Severe neutropenia was defined as Grade 4 neutropenia (ANC <0.5 x 10^9/L). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10^9/L after beginning a chemotherapy cycle until the participant had an ANC ≥0.5 x 10^9/L within the cycle. There was no planned statistical analysis for the open-label phase arm.
Time Frame
Cycle 1 (cycle length = 21 days)
Secondary Outcome Measure Information:
Title
Double-Blind Phase: Number of Participants With Febrile Neutropenia
Description
Febrile neutropenia was defined as an imputed or observed ANC <0.5 x 10^9/L and body temperature >38.5 degrees celsius (°C) occurring on the same day and for more than one hour (axillary measurement). Number of participants with febrile neutropenia over all cycles (Cycles 1 to 4) has been reported.
Time Frame
Cycles 1-4 (each cycle = 21 days)
Title
Open-Label Phase: Number of Participants With Febrile Neutropenia
Description
Febrile neutropenia was defined as an imputed or observed ANC <0.5 x 10^9/L and body temperature >38.5 °C occurring on the same day and for more than one hour (axillary measurement). Number of participants with febrile neutropenia over all cycles (Cycles 1 to 4) has been reported.
Time Frame
Cycles 1-4 (each cycle = 21 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teva Medical Expert, MD
Organizational Affiliation
Teva Branded Pharmaceutical Products R&D, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Teva Investigational Site 3502
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Facility Name
Teva Investigational Site 3511
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
Teva Investigational Site 3504
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Teva Investigational Site 3501
City
Shumen
ZIP/Postal Code
9700
Country
Bulgaria
Facility Name
Teva Investigational Site 3506
City
Sofia District
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Teva Investigational Site 3503
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Facility Name
Teva Investigational Site 3505
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Teva Investigational Site 3507
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Teva Investigational Site 4001
City
Baia Mare, Maramures County
ZIP/Postal Code
430031
Country
Romania
Facility Name
Teva Investigational Site 4009
City
Brasov
ZIP/Postal Code
500366
Country
Romania
Facility Name
Teva Investigational Site 4004
City
Bucharest
ZIP/Postal Code
020962
Country
Romania
Facility Name
Teva Investigational Site 4002
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Teva Investigational Site 4011
City
Cluj-Napoca
ZIP/Postal Code
999999
Country
Romania
Facility Name
Teva Investigational Site 4005
City
Craiova, Dolj County
ZIP/Postal Code
200535
Country
Romania
Facility Name
Teva Investigational Site 4010
City
Lasi County
ZIP/Postal Code
700106
Country
Romania
Facility Name
Teva Investigational Site 4007
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
Facility Name
Teva Investigational Site 0714
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Teva Investigational Site 0707
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Teva Investigational Site 0702
City
Ekaterinburg
ZIP/Postal Code
620036
Country
Russian Federation
Facility Name
Teva Investigational Site 0708
City
Ivanovo
ZIP/Postal Code
153013
Country
Russian Federation
Facility Name
Teva Investigational Site 0721
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Teva Investigational Site 0709
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
Teva Investigational Site 0711
City
Kursk
ZIP/Postal Code
305035
Country
Russian Federation
Facility Name
Teva Investigational Site 0713
City
Leningrad Region
ZIP/Postal Code
188663
Country
Russian Federation
Facility Name
Teva Investigational Site 0710
City
Moscow
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
Teva Investigational Site 0703
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
Teva Investigational Site 0716
City
Nizhny Novgorod
ZIP/Postal Code
603081
Country
Russian Federation
Facility Name
Teva Investigational Site 0720
City
Orel
ZIP/Postal Code
302020
Country
Russian Federation
Facility Name
Teva Investigational Site 0724
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
Teva Investigational Site 0725
City
Rostov-on-Don
ZIP/Postal Code
344037
Country
Russian Federation
Facility Name
Teva Investigational Site 0704
City
Saint Petersburg
ZIP/Postal Code
194017
Country
Russian Federation
Facility Name
Teva Investigational Site 0722
City
Saint Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
Teva Investigational Site 0706
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Teva Investigational Site 0715
City
Saint Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Teva Investigational Site 0712
City
Samara
ZIP/Postal Code
443031
Country
Russian Federation
Facility Name
Teva Investigational Site 0723
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
Teva Investigational Site 0717
City
Tambov
ZIP/Postal Code
392013
Country
Russian Federation
Facility Name
Teva Investigational Site 0719
City
Ufa
ZIP/Postal Code
450007
Country
Russian Federation
Facility Name
Teva Investigational Site 0705
City
Yaroslavl
ZIP/Postal Code
150040
Country
Russian Federation
Facility Name
Teva Investigational Site 8102
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Teva Investigational Site 8103
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Teva Investigational Site 8104
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Teva Investigational Site 8105
City
Nis
ZIP/Postal Code
18 000
Country
Serbia
Facility Name
Teva Investigational Site 3807
City
Chernihiv
ZIP/Postal Code
14029
Country
Ukraine
Facility Name
Teva Investigational Site 3805
City
Chernivtsi
ZIP/Postal Code
58013
Country
Ukraine
Facility Name
Teva Investigational Site 3802
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Teva Investigational Site 3811
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
Teva Investigational Site 3806
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Teva Investigational Site 3814
City
Kharkiv
ZIP/Postal Code
61024
Country
Ukraine
Facility Name
Teva Investigational Site 3804
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Teva Investigational Site 3816
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Teva Investigational Site 3803
City
Khmelnytskyi
ZIP/Postal Code
29009
Country
Ukraine
Facility Name
Teva Investigational Site 3808
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Teva Investigational Site 3817
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Teva Investigational Site 3812
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
Teva Investigational Site 3809
City
Mariupol, Donetsk Region
ZIP/Postal Code
87500
Country
Ukraine
Facility Name
Teva Investigational Site 3801
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Teva Investigational Site 3815
City
Sumy
ZIP/Postal Code
40005
Country
Ukraine
Facility Name
Teva Investigational Site 3810
City
Uzhhorod
ZIP/Postal Code
88014
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
24485296
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.
Results Reference
derived

Learn more about this trial

Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel

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