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Completed

NCT Number: NCT00837265

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

Determination of the effect of balugrastim on the duration and severity of severe neutropenia.

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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 2 / Phase 3

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

Balugrastim

Biological

Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description.

Other names: Neugranin

pegfilgrastim

Drug

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

Chemotherapy Regimen

Drug

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 outcomes

  1. 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.

Secondary outcomes

  1. Number of Participants With Febrile Neutropenia

    Time frame: Cycles 1 to 4 (each cycle length = 21 days)

    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.

  2. Duration of Severe Neutropenia in Cycles 2, 3, and 4

    Time frame: Cycles 2, 3, and 4 (each 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.

  3. Time to Absolute Neutrophil Count (ANC) Recovery in Cycles 1, 2, 3, and 4

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study 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)

Acronym: NEUGR-002

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 5, 2009
Registry last updated
Apr 3, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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