Phase 3
N=78
Balugrastim (Neugranin) in Breast Cancer Participants Receiving Doxorubicin/Docetaxel
Chemotherapy-induced Neutropenia
Bottom Line
View on ClinicalTrials.gov: NCT00837265 ↗Enrolled (actual)
78
Serious AEs
10.0%
Results posted
Feb 2023
Primary outcome: Primary: Duration of Severe Neutropenia in Cycle 1 — 0.9; 1.6; 1.1; 0.9 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Balugrastim (Biological); Pegfilgrastim (Drug); Chemotherapy Regimen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Severe Neutropenia in Cycle 1 |
0.9; 1.6; 1.1; 0.9; 1.0; 1.3 | — |
| SECONDARY Number of Participants With Febrile Neutropenia |
2; 3; 2; 2; 4; 5 | — |
| SECONDARY Duration of Severe Neutropenia in Cycles 2, 3, and 4 |
0.0; 0.8; 0.4; 0.5; 0.5; 0.4 | — |
| SECONDARY Time to Absolute Neutrophil Count (ANC) Recovery in Cycles 1, 2, 3, and 4 |
3.1; 2.6; 2.0; 2.4; 2.0; 2.1 | — |
Summary
Determination of the effect of balugrastim on the duration and severity of severe neutropenia.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT00837265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.