Phase 3
N=304
Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel
Chemotherapy-induced Neutropenia
Bottom Line
View on ClinicalTrials.gov: NCT01126190 ↗Enrolled (actual)
304
Serious AEs
5.0%
Results posted
Mar 2023
Primary outcome: Primary: Double-Blind Phase: Duration of Severe Neutropenia in Cycle 1 — 1.0; 1.1 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Neugranin (Biological); Pegfilgrastim (Biological); Chemotherapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Primary completion
- Feb 2012
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 | — |
Summary
Determination of the effect of neugranin on the duration and severity of severe neutropenia in participants receiving doxorubicin in combination with docetaxel.
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). 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.