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

February 28, 2023 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

381

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Gabrovo, Bulgaria, 5300
        • Teva Investigational Site 3502
      • Plovdiv, Bulgaria, 4004
        • Teva Investigational Site 3511
      • Ruse, Bulgaria, 7002
        • Teva Investigational Site 3504
      • Shumen, Bulgaria, 9700
        • Teva Investigational Site 3501
      • Sofia District, Bulgaria, 1233
        • Teva Investigational Site 3506
      • Stara Zagora, Bulgaria, 6003
        • Teva Investigational Site 3503
      • Varna, Bulgaria, 9010
        • Teva Investigational Site 3505
      • Veliko Tarnovo, Bulgaria, 5000
        • Teva Investigational Site 3507
  • Romania
      • Baia Mare, Maramures County, Romania, 430031
        • Teva Investigational Site 4001
      • Brasov, Romania, 500366
        • Teva Investigational Site 4009
      • Bucharest, Romania, 020962
        • Teva Investigational Site 4004
      • Cluj Napoca, Romania, 400015
        • Teva Investigational Site 4002
      • Cluj-Napoca, Romania, 999999
        • Teva Investigational Site 4011
      • Craiova, Dolj County, Romania, 200535
        • Teva Investigational Site 4005
      • Lasi County, Romania, 700106
        • Teva Investigational Site 4010
      • Timisoara, Romania, 300239
        • Teva Investigational Site 4007
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • Teva Investigational Site 0714
      • Chelyabinsk, Russian Federation, 454087
        • Teva Investigational Site 0707
      • Ekaterinburg, Russian Federation, 620036
        • Teva Investigational Site 0702
      • Ivanovo, Russian Federation, 153013
        • Teva Investigational Site 0708
      • Kazan, Russian Federation, 420029
        • Teva Investigational Site 0721
      • Krasnodar, Russian Federation, 350040
        • Teva Investigational Site 0709
      • Kursk, Russian Federation, 305035
        • Teva Investigational Site 0711
      • Leningrad Region, Russian Federation, 188663
        • Teva Investigational Site 0713
      • Moscow, Russian Federation, 121359
        • Teva Investigational Site 0710
      • Moscow, Russian Federation, 129128
        • Teva Investigational Site 0703
      • Nizhny Novgorod, Russian Federation, 603081
        • Teva Investigational Site 0716
      • Orel, Russian Federation, 302020
        • Teva Investigational Site 0720
      • Pyatigorsk, Russian Federation, 357502
        • Teva Investigational Site 0724
      • Rostov-on-Don, Russian Federation, 344037
        • Teva Investigational Site 0725
      • Saint Petersburg, Russian Federation, 194017
        • Teva Investigational Site 0704
      • Saint Petersburg, Russian Federation, 195067
        • Teva Investigational Site 0722
      • Saint Petersburg, Russian Federation, 197758
        • Teva Investigational Site 0706
      • Saint Petersburg, Russian Federation, 198255
        • Teva Investigational Site 0715
      • Samara, Russian Federation, 443031
        • Teva Investigational Site 0712
      • Sochi, Russian Federation, 354057
        • Teva Investigational Site 0723
      • Tambov, Russian Federation, 392013
        • Teva Investigational Site 0717
      • Ufa, Russian Federation, 450007
        • Teva Investigational Site 0719
      • Yaroslavl, Russian Federation, 150040
        • Teva Investigational Site 0705
  • Serbia
      • Belgrade, Serbia, 11000
        • Teva Investigational Site 8102
      • Belgrade, Serbia, 11000
        • Teva Investigational Site 8103
      • Kragujevac, Serbia, 34000
        • Teva Investigational Site 8104
      • Nis, Serbia, 18 000
        • Teva Investigational Site 8105
  • Ukraine
      • Chernihiv, Ukraine, 14029
        • Teva Investigational Site 3807
      • Chernivtsi, Ukraine, 58013
        • Teva Investigational Site 3805
      • Dnipropetrovsk, Ukraine, 49102
        • Teva Investigational Site 3802
      • Donetsk, Ukraine, 83092
        • Teva Investigational Site 3811
      • Ivano-Frankivsk, Ukraine, 76018
        • Teva Investigational Site 3806
      • Kharkiv, Ukraine, 61024
        • Teva Investigational Site 3814
      • Kharkiv, Ukraine, 61070
        • Teva Investigational Site 3804
      • Kharkiv, Ukraine, 61070
        • Teva Investigational Site 3816
      • Khmelnytskyi, Ukraine, 29009
        • Teva Investigational Site 3803
      • Kyiv, Ukraine, 03115
        • Teva Investigational Site 3808
      • Kyiv, Ukraine, 03115
        • Teva Investigational Site 3817
      • Lviv, Ukraine, 79031
        • Teva Investigational Site 3812
      • Mariupol, Donetsk Region, Ukraine, 87500
        • Teva Investigational Site 3809
      • Odesa, Ukraine, 65025
        • Teva Investigational Site 3801
      • Sumy, Ukraine, 40005
        • Teva Investigational Site 3815
      • Uzhhorod, Ukraine, 88014
        • Teva Investigational Site 3810

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Biological: Pegfilgrastim
Pegfilgrastim will be administered per dose and schedule specified in the arm description.
Other Names:
  • Neulasta
Drug: Chemotherapy
The chemotherapy regimen for this trial consists of doxorubicin 60 mg/m^2 and docetaxel 75 mg/m^2 in combination
Other Names:
  • Doxorubicin/Docetaxel
Experimental: 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.
Drug: Chemotherapy
The chemotherapy regimen for this trial consists of doxorubicin 60 mg/m^2 and docetaxel 75 mg/m^2 in combination
Other Names:
  • Doxorubicin/Docetaxel
Biological: Neugranin
Neugranin will be administered per dose and schedule specified in the arm description.
Other Names:
  • Balugrastim
Experimental: 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.
Drug: Chemotherapy
The chemotherapy regimen for this trial consists of doxorubicin 60 mg/m^2 and docetaxel 75 mg/m^2 in combination
Other Names:
  • Doxorubicin/Docetaxel
Biological: Neugranin
Neugranin will be administered per dose and schedule specified in the arm description.
Other Names:
  • Balugrastim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Double-Blind Phase: Duration of Severe Neutropenia in Cycle 1
Time Frame: Cycle 1 (cycle length = 21 days)
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.
Cycle 1 (cycle length = 21 days)
Open-Label Phase: Duration of Severe Neutropenia in Cycle 1
Time Frame: Cycle 1 (cycle length = 21 days)
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.
Cycle 1 (cycle length = 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Double-Blind Phase: Number of Participants With Febrile Neutropenia
Time Frame: Cycles 1-4 (each cycle = 21 days)
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.
Cycles 1-4 (each cycle = 21 days)
Open-Label Phase: Number of Participants With Febrile Neutropenia
Time Frame: Cycles 1-4 (each cycle = 21 days)
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.
Cycles 1-4 (each cycle = 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2010

Primary Completion (Actual)

February 29, 2012

Study Completion (Actual)

February 29, 2012

Study Registration Dates

First Submitted

May 4, 2010

First Submitted That Met QC Criteria

May 17, 2010

First Posted (Estimate)

May 19, 2010

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEUGR-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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