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Completed

NCT Number: NCT01126190

Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel

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

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Key information

Conditions

Chemotherapy-induced Neutropenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Teva Investigational Site 3502, Gabrovo, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Neugranin

Biological

Neugranin will be administered per dose and schedule specified in the arm description.

Other names: Balugrastim

Pegfilgrastim

Biological

Pegfilgrastim will be administered per dose and schedule specified in the arm description.

Other names: Neulasta

Chemotherapy

Drug

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study 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

Acronym: NEUGR-003

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 19, 2010
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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