Trials / Completed
CompletedNCT00837265
Balugrastim (Neugranin) in Breast Cancer Participants Receiving Doxorubicin/Docetaxel
A Randomized Study of Subcutaneously Administered Neugranin (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) or Pegfilgrastim in Subjects With Breast Cancer Receiving Myelosuppressive Chemotherapy (Doxorubicin/Docetaxel)
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 334 (actual)
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Determination of the effect of balugrastim on the duration and severity of severe neutropenia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Balugrastim | Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description. |
| DRUG | Pegfilgrastim | Pegfilgrastim will be administered per dose and schedule specified in the arm description. |
| DRUG | Chemotherapy Regimen | The chemotherapy regimen consisting of doxorubicin 60 mg/square meter (m\^2) and docetaxel 75 mg/m\^2 will be administered sequentially by intravenous (IV) infusion on Day 1 of treatment for up to four 21-day cycles. |
Timeline
- Start date
- 2008-08-21
- Primary completion
- 2009-06-26
- Completion
- 2009-06-26
- First posted
- 2009-02-05
- Last updated
- 2024-04-03
- Results posted
- 2023-02-03
Source: ClinicalTrials.gov record NCT00837265. Inclusion in this directory is not an endorsement.