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NCT01516736 · ClinicalTrials.gov registry record · Phase 3
Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim
A Phase 3 study of Breast Cancer and Chemotherapy-induced Neutropenia, sponsored by Sandoz.
- Completed
- Registry status
- Phase 3
- Development phase
- 308
- Enrollment target
- 20
- Study locations
NCT01516736: Completed Phase 3 study of Breast Cancer and Chemotherapy-induced Neutropenia, sponsored by Sandoz.
NCT01516736 is a Phase 3 study of Breast Cancer and Chemotherapy-induced Neutropenia that has completed, run by Sandoz. The registered enrollment target is 308 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01516736, a Phase 3 study of Breast Cancer and Chemotherapy-induced Neutropenia, has completed, sponsored by Sandoz.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 308 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Mean duration of severe neutropenia, defined as number of consecutive days with ANC \<0.5 × 10\^9/l (grade 4 neutropenia).
Conditions Studied
Interventions
- DRUG LA-EP2006
- DRUG Neulasta®
Study Locations (20)
Other
- Sandoz Investigational Site - San Miguel de Tucumán
- Sandoz Investigational Site - Temuco
- Sandoz Investigational Site - Chennai
- Sandoz Investigational Site - Delhi
- Sandoz Investigational Site - Gujarat
- Sandoz Investigational Site - Hyderabad
- Sandoz Investigational Site - Karamsad
- Sandoz Investigational Site - Lucknow
- Sandoz Investigational Site - Maharashtra
- Sandoz Investigational Site - Mangalore
Arkansas
- Sandoz Investigational Site - Hot Springs
- Sandoz Investigational Site - Jonesboro
California
- Sandoz Investigational Site - Corona
Kansas
- Sandoz Investigational Site - Wichita
Kentucky
- Sandoz Investigational Site - Mount Sterling
Michigan
- Sandoz Investigational Site - Detroit
North Dakota
- Sandoz Investigational Site - Bismarck
Oregon
- Sandoz Investigational Site - Eugene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 308 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-12 |
| Phase | Phase 3 |
What the finished NCT01516736 record still lists
NCT01516736 is an interventional study that assigns participants to a tested intervention. The registered 308 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which LA-EP2006 is the first listed.
NCT01516736 names 20 study sites across 10 states, led by Other, Arkansas, California.
Frequently Asked Questions
What is clinical trial NCT01516736 about?
NCT01516736 is a clinical study titled "Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim". 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.
What is the current status of trial NCT01516736?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 308 participants. The study started on 2012-03. Estimated completion is 2013-12.
What conditions does trial NCT01516736 study?
This clinical trial studies the following conditions: Breast Cancer, Chemotherapy-induced Neutropenia.
What interventions are being tested in trial NCT01516736?
The interventions under investigation include: LA-EP2006 (DRUG), Neulasta® (DRUG).
Who is sponsoring clinical trial NCT01516736?
This trial is sponsored by Sandoz, which has 29 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01516736 being conducted?
This trial has 20 study locations across Arkansas, California, Kansas, Kentucky, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01516736's enrollment target sits among peer trials
308 272nd of 1224 higher than 953 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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