Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00193206 · ClinicalTrials.gov registry record · Phase 2
Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer
A Phase 2 study, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 2
- Development phase
- 123
- Enrollment target
NCT00193206: Completed Phase 2 study, sponsored by SCRI Development Innovations.
NCT00193206 is a Phase 2 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 123 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00193206, a Phase 2 study, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 123 participants
- Enrollment target
Study Summary
In this trial we will evaluate ABI-007 with gemcitabine and epirubicin, utilizing the biweekly pegfilgrastim support, in order to further improve upon the effectiveness and favorable toxicity of this triplet.
Primary Outcome
For the purpose of this study, a pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0) and axillary lymph nodes (pN0), gross or microscopic, in the sample removed at the time of surgical resection. Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.
Interventions
- DRUG Gemcitabine
- DRUG Epirubicin
- DRUG Albumin-bound Paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2005-09 |
| Est. Completion | 2009-05 |
| Phase | Phase 2 |
What the finished NCT00193206 record still lists
NCT00193206 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Gemcitabine is the first listed.
NCT00193206 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00193206 about?
NCT00193206 is a clinical study titled "Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer". In this trial we will evaluate ABI-007 with gemcitabine and epirubicin, utilizing the biweekly pegfilgrastim support, in order to further improve upon the effectiveness and favorable toxicity of this triplet.
What is the current status of trial NCT00193206?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 123 participants. The study started on 2005-09. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00193206?
The interventions under investigation include: Gemcitabine (DRUG), Epirubicin (DRUG), Albumin-bound Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT00193206?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00193206's enrollment target sits among peer trials
123 564th of 2000 higher than 1,436 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05285891 · 123 participants · Phase 4
Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis
- NCT05334368 · 123 participants · Phase 3
Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial
- NCT06088355 · 123 participants · NA
Moderate Versus High Volume Light-Moderate Intensity Exercise for People With Moderate Parkinson's Disease
- NCT06111131 · 123 participants · NA
Ancora-SB Overtube Complete Positioning and Optical Visualization During Endoscopic Procedures
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia