Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim
Public ClinicalTrials.gov record NCT01516736. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Pivotal Study in Breast Cancer Patients Investigating Efficacy and Safety of LA-EP2006 and Neulasta®
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
Study identification
- NCT ID
- NCT01516736
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 308 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 29, 2012
- Primary completion
- Jul 31, 2013
- Completion
- Nov 30, 2013
- Last update posted
- Aug 29, 2017
2012 – 2013
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sandoz Investigational Site | Hot Springs | Arkansas | 71913 | — |
| Sandoz Investigational Site | Jonesboro | Arkansas | 72401 | — |
| Sandoz Investigational Site | Corona | California | 92879 | — |
| Sandoz Investigational Site | Wichita | Kansas | 67214 | — |
| Sandoz Investigational Site | Mount Sterling | Kentucky | 40353 | — |
| Sandoz Investigational Site | Detroit | Michigan | 48202 | — |
| Sandoz Investigational Site | Bismarck | North Dakota | 58501 | — |
| Sandoz Investigational Site | Eugene | Oregon | 97401 | — |
| Sandoz Investigational Site | Germantown | Tennessee | 38138 | — |
| Sandoz Investigational Site | Newport News | Virginia | 23601 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 43 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01516736, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 29, 2017 · Synced Sep 26, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01516736 live on ClinicalTrials.gov.