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Balugrastim (Neugranin) in Breast Cancer Participants Receiving Doxorubicin/Docetaxel (NEUGR-002)

Primary Purpose

Chemotherapy-induced Neutropenia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Balugrastim
Pegfilgrastim
Chemotherapy Regimen
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 focused on measuring Breast Cancer Supportive Care 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

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Pilot Phase: Balugrastim Low Dose

    Pilot Phase: Balugrastim Medium Dose

    Pilot Phase: Balugrastim High Dose

    Pilot Phase: Pegfilgrastim

    Main Phase: Balugrastim Medium Dose

    Main Phase: Balugrastim High Dose

    Main Phase: Pegfilgrastim

    Arm Description

    Participants will receive balugrastim low dose 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).

    Participants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).

    Participants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).

    Participants will receive pegfilgrastim 6 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).

    Participants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).

    Participants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).

    Participants will receive pegfilgrastim 6 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).

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Number of Participants With Febrile Neutropenia
    Febrile neutropenia was defined as an imputed or observed ANC <0.5 x 10^9/L and oral temperature ≥38.2 degrees celsius (°C) occurring on the same day. Number of participants with febrile neutropenia over all cycles (Cycles 1 to 4) has been reported.
    Duration of Severe Neutropenia in Cycles 2, 3, and 4
    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.
    Time to Absolute Neutrophil Count (ANC) Recovery in Cycles 1, 2, 3, and 4
    Time to ANC recovery was defined as the time from the nadir ANC to an ANC ≥1.5 x 10^9/L and was calculated for participants with ANC <1.5 x 10^9/L after the beginning of a chemotherapy cycle. Time to ANC recovery was calculated by cycle as the number of days from the nadir (the lowest ANC during a chemotherapy cycle) until a participant reached an ANC >1.5 x 10^9/L.

    Full Information

    First Posted
    February 4, 2009
    Last Updated
    January 9, 2023
    Sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00837265
    Brief Title
    Balugrastim (Neugranin) in Breast Cancer Participants Receiving Doxorubicin/Docetaxel
    Acronym
    NEUGR-002
    Official Title
    A Randomized 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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    August 21, 2008 (Actual)
    Primary Completion Date
    June 26, 2009 (Actual)
    Study Completion Date
    June 26, 2009 (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 balugrastim on the duration and severity of severe neutropenia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chemotherapy-induced Neutropenia
    Keywords
    Breast Cancer Supportive Care Neutropenia

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    334 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pilot Phase: Balugrastim Low Dose
    Arm Type
    Experimental
    Arm Description
    Participants will receive balugrastim low dose 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).
    Arm Title
    Pilot Phase: Balugrastim Medium Dose
    Arm Type
    Experimental
    Arm Description
    Participants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
    Arm Title
    Pilot Phase: Balugrastim High Dose
    Arm Type
    Experimental
    Arm Description
    Participants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
    Arm Title
    Pilot Phase: Pegfilgrastim
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive pegfilgrastim 6 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).
    Arm Title
    Main Phase: Balugrastim Medium Dose
    Arm Type
    Experimental
    Arm Description
    Participants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
    Arm Title
    Main Phase: Balugrastim High Dose
    Arm Type
    Experimental
    Arm Description
    Participants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days).
    Arm Title
    Main Phase: Pegfilgrastim
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive pegfilgrastim 6 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).
    Intervention Type
    Biological
    Intervention Name(s)
    Balugrastim
    Other Intervention Name(s)
    Neugranin
    Intervention Description
    Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description.
    Intervention Type
    Drug
    Intervention Name(s)
    Pegfilgrastim
    Intervention Description
    Pegfilgrastim will be administered per dose and schedule specified in the arm description.
    Intervention Type
    Drug
    Intervention Name(s)
    Chemotherapy Regimen
    Intervention Description
    The chemotherapy regimen consisting of doxorubicin 60 mg/square meter (m^2) and docetaxel 75 mg/m^2 will be administered sequentially by intravenous (IV) infusion on Day 1 of treatment for up to four 21-day cycles.
    Primary Outcome Measure Information:
    Title
    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)
    Secondary Outcome Measure Information:
    Title
    Number of Participants With Febrile Neutropenia
    Description
    Febrile neutropenia was defined as an imputed or observed ANC <0.5 x 10^9/L and oral temperature ≥38.2 degrees celsius (°C) occurring on the same day. Number of participants with febrile neutropenia over all cycles (Cycles 1 to 4) has been reported.
    Time Frame
    Cycles 1 to 4 (each cycle length = 21 days)
    Title
    Duration of Severe Neutropenia in Cycles 2, 3, and 4
    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.
    Time Frame
    Cycles 2, 3, and 4 (each cycle length = 21 days)
    Title
    Time to Absolute Neutrophil Count (ANC) Recovery in Cycles 1, 2, 3, and 4
    Description
    Time to ANC recovery was defined as the time from the nadir ANC to an ANC ≥1.5 x 10^9/L and was calculated for participants with ANC <1.5 x 10^9/L after the beginning of a chemotherapy cycle. Time to ANC recovery was calculated by cycle as the number of days from the nadir (the lowest ANC during a chemotherapy cycle) until a participant reached an ANC >1.5 x 10^9/L.
    Time Frame
    Cycles 1, 2, 3, and 4

    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

    12. IPD Sharing Statement

    Learn more about this trial

    Balugrastim (Neugranin) in Breast Cancer Participants Receiving Doxorubicin/Docetaxel

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