Balugrastim (Neugranin) in Breast Cancer Participants Receiving Doxorubicin/Docetaxel (NEUGR-002)
Status and phase
Completed
Phase 3
Phase 2
Conditions
Chemotherapy-induced Neutropenia
Treatments
Biological: Balugrastim
Drug: Chemotherapy Regimen
Drug: Pegfilgrastim
Details and patient eligibility
About
Determination of the effect of balugrastim on the duration and severity of severe neutropenia.
Enrollment
334 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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).
Trial design
Primary purpose
Supportive Care
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
334 participants in 7 patient groups
Pilot Phase: Balugrastim Low Dose
Experimental group
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).
Treatment:
Drug: Chemotherapy Regimen
Biological: Balugrastim
Pilot Phase: Balugrastim Medium Dose
Experimental group
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).
Treatment:
Drug: Chemotherapy Regimen
Biological: Balugrastim
Pilot Phase: Balugrastim High Dose
Experimental group
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).
Treatment:
Drug: Chemotherapy Regimen
Biological: Balugrastim
Pilot Phase: Pegfilgrastim
Active Comparator group
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).
Treatment:
Drug: Chemotherapy Regimen
Drug: Pegfilgrastim
Main Phase: Balugrastim Medium Dose
Experimental group
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).
Treatment:
Drug: Chemotherapy Regimen
Biological: Balugrastim
Main Phase: Balugrastim High Dose
Experimental group
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).
Treatment:
Drug: Chemotherapy Regimen
Biological: Balugrastim
Main Phase: Pegfilgrastim
Active Comparator group
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).
Treatment:
Drug: Chemotherapy Regimen
Drug: Pegfilgrastim
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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