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

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)

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

Study Overview

• Status: Completed
• Conditions: Chemotherapy-induced Neutropenia
• Intervention / Treatment: Biological: Balugrastim; Drug: Chemotherapy Regimen; Drug: Pegfilgrastim

• Study Type: Interventional
• Enrollment (Actual): 334
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pilot Phase: Balugrastim Low Dose; 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).	Biological: Balugrastim; Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description.; Other Names: Neugranin; Drug: Chemotherapy Regimen; 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.
Experimental: Pilot Phase: Balugrastim Medium Dose; 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).	Biological: Balugrastim; Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description.; Other Names: Neugranin; Drug: Chemotherapy Regimen; 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.
Experimental: Pilot Phase: Balugrastim High Dose; 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).	Biological: Balugrastim; Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description.; Other Names: Neugranin; Drug: Chemotherapy Regimen; 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.
Active Comparator: Pilot Phase: Pegfilgrastim; 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).	Drug: Chemotherapy Regimen; 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.; Drug: Pegfilgrastim; Pegfilgrastim will be administered per dose and schedule specified in the arm description.
Experimental: Main Phase: Balugrastim Medium Dose; 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).	Biological: Balugrastim; Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description.; Other Names: Neugranin; Drug: Chemotherapy Regimen; 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.
Experimental: Main Phase: Balugrastim High Dose; 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).	Biological: Balugrastim; Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description.; Other Names: Neugranin; Drug: Chemotherapy Regimen; 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.
Active Comparator: Main Phase: Pegfilgrastim; 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).	Drug: Chemotherapy Regimen; 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.; Drug: Pegfilgrastim; Pegfilgrastim will be administered per dose and schedule specified in the arm description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Cycle 1 (cycle length = 21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Cycles 1 to 4 (each cycle length = 21 days)
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.	Cycles 2, 3, and 4 (each cycle length = 21 days)
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.	Cycles 1, 2, 3, and 4

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Investigators: Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2008
• Primary Completion (Actual): June 26, 2009
• Study Completion (Actual): June 26, 2009

Study Registration Dates

• First Submitted: February 4, 2009
• First Submitted That Met QC Criteria: February 4, 2009
• First Posted (Estimated): February 5, 2009

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Breast Cancer Supportive Care Neutropenia
• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Cytopenia; Neutropenia
• Other Study ID Numbers: NEUGR-002