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NCT02643420 · ClinicalTrials.gov registry record · Phase 3
SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)
A Phase 3 study, sponsored by Spectrum Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 406
- Enrollment target
NCT02643420: Completed Phase 3 study, sponsored by Spectrum Pharmaceuticals.
NCT02643420 is a Phase 3 study that has completed, run by Spectrum Pharmaceuticals. The registered enrollment target is 406 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02643420, a Phase 3 study, has completed, sponsored by Spectrum Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 406 participants
- Enrollment target
Study Summary
The purpose of this study was to compare the efficacy of a single dose of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC), as measured by the duration of severe neutropenia (DSN) in Cycle 1.
Primary Outcome
DSN was defined as the number of days of severe neutropenia (absolute neutrophil count \[ANC\] \<0.5×10\^9/L), after the administration of study drug in Cycle 1.
Interventions
- DRUG Cyclophosphamide
- DRUG Docetaxel
- DRUG Pegfilgrastim
- DRUG SPI-2012
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 406 participants |
| Start Date | 2016-01-19 |
| Est. Completion | 2018-10-31 |
| Phase | Phase 3 |
What the finished NCT02643420 record still lists
NCT02643420 is an interventional study that assigns participants to a tested intervention. The registered 406 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT02643420 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02643420 about?
NCT02643420 is a clinical study titled "SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)". The purpose of this study was to compare the efficacy of a single dose of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC), as measured by the duration of severe neutropenia (DSN) in Cycle 1.
What is the current status of trial NCT02643420?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 406 participants. The study started on 2016-01-19. Estimated completion is 2018-10-31.
What interventions are being tested in trial NCT02643420?
The interventions under investigation include: Cyclophosphamide (DRUG), Docetaxel (DRUG), Pegfilgrastim (DRUG), SPI-2012 (DRUG).
Who is sponsoring clinical trial NCT02643420?
This trial is sponsored by Spectrum Pharmaceuticals, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02643420's enrollment target sits among peer trials
406 913th of 2000 higher than 1,087 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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