Phase 3
Completed N=304
Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel
Source: ClinicalTrials.gov NCT01126190 ↗Enrolled (actual)
304
Serious AEs
5.0%
Results posted
Mar 2023
Primary outcomePrimary: Double-Blind Phase: Duration of Severe Neutropenia in Cycle 1 — 1.0; 1.1 days
◆ Published Evidence
Established
26citations · ~2 / year
Efficacy and safety of balugrastim compared with pegfilgrastim in patients with breast cancer receiving chemotherapy.
Summary
Determination of the effect of neugranin on the duration and severity of severe neutropenia in participants receiving doxorubicin in combination with docetaxel.
Linked Publications
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Efficacy and safety of balugrastim compared with pegfilgrastim in patients with breast cancer receiving chemotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Double-Blind Phase: Duration of Severe Neutropenia in Cycle 1 |
1.0; 1.1 | — |
| PRIMARY Open-Label Phase: Duration of Severe Neutropenia in Cycle 1 |
1.0 | — |
| SECONDARY Double-Blind Phase: Number of Participants With Febrile Neutropenia |
4; 2 | — |
| SECONDARY Open-Label Phase: Number of Participants With Febrile Neutropenia |
2 | — |
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 (NCT01126190) and the linked publication. 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. Informational only — not medical advice.