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

Phase 2

Completed

• Conditions: Chemotherapy-induced Neutropenia
• Interventions: Drug: Pegfilgrastim; Biological: Balugrastim; Drug: Chemotherapy Regimen

• Registration Number: NCT00837265
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-21
• Study First Submitted: 2009-02-04
• Study First Submitted QC: 2009-02-04
• Study First Posted: 2009-02-05
• Primary Completion: 2009-06-26
• Study Completion: 2009-06-26
• Disposition First Submitted: 2013-08-27
• Disposition First Submitted QC: 2013-08-27
• Disposition First Posted: 2013-09-12
• Results First Submitted: 2023-01-09
• Results First Submitted QC: 2023-01-09
• Results First Posted: 2023-02-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 334

Inclusion Criteria

• Breast cancer participants scheduled to receive the AT regimen (doxorubicin/ docetaxel).

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Exclusion Criteria

• Participants may have received no more than 1 prior chemotherapy regimen (including adjuvant therapy if given within the last 12 months).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Main Phase: Pegfilgrastim	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).
Pilot Phase: Balugrastim Low Dose	Balugrastim	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).
Pilot Phase: Balugrastim Low Dose	Chemotherapy Regimen	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).
Pilot Phase: Balugrastim Medium Dose	Balugrastim	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).
Pilot Phase: Balugrastim Medium Dose	Chemotherapy Regimen	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).
Pilot Phase: Balugrastim High Dose	Balugrastim	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).
Pilot Phase: Balugrastim High Dose	Chemotherapy Regimen	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).
Pilot Phase: Pegfilgrastim	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).
Pilot Phase: Pegfilgrastim	Chemotherapy Regimen	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).
Main Phase: Balugrastim Medium Dose	Balugrastim	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).
Main Phase: Balugrastim Medium Dose	Chemotherapy Regimen	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).
Main Phase: Balugrastim High Dose	Balugrastim	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).
Main Phase: Balugrastim High Dose	Chemotherapy Regimen	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).
Main Phase: Pegfilgrastim	Chemotherapy Regimen	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).

Primary Outcome Measures

Name	Time	Method
Duration of Severe Neutropenia in Cycle 1	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 Outcome Measures

Name	Time	Method
Number of Participants With Febrile Neutropenia	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.
Time to Absolute Neutrophil Count (ANC) Recovery in Cycles 1, 2, 3, and 4	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.
Duration of Severe Neutropenia in Cycles 2, 3, and 4	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.