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NCT00191451 · ClinicalTrials.gov registry record · Phase 2
A Study of Gemcitabine and Carboplatin (Plus Herceptin in Human Epidermal Growth Factor Receptor 2 Positive [HER2+] Patients) With Metastatic Breast Cancer
A Phase 2 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
NCT00191451: Completed Phase 2 study, sponsored by Eli Lilly and Company.
NCT00191451 is a Phase 2 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 150 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00191451, a Phase 2 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
Study Summary
The purposes of this study are to determine the safety of gemcitabine and paraplatin either with or without trastuzumab Any side effects that might be associated with these compounds. Whether the two or three drugs listed above when given in combination can help patients with metastatic breast cancer. How long the treatment will stop the growth of the cancer.
Primary Outcome
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Interventions
- DRUG Carboplatin
- DRUG Gemcitabine
- DRUG Herceptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2004-04 |
| Est. Completion | 2008-10 |
| Phase | Phase 2 |
What the finished NCT00191451 record still lists
NCT00191451 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 3 interventions - of which Carboplatin is the first listed.
NCT00191451 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00191451 about?
NCT00191451 is a clinical study titled "A Study of Gemcitabine and Carboplatin (Plus Herceptin in Human Epidermal Growth Factor Receptor 2 Positive [HER2+] Patients) With Metastatic Breast Cancer". The purposes of this study are to determine the safety of gemcitabine and paraplatin either with or without trastuzumab Any side effects that might be associated with these compounds. Whether the two or three drugs listed above when given in combination can help patients with metastatic breast cance...
What is the current status of trial NCT00191451?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2004-04. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00191451?
The interventions under investigation include: Carboplatin (DRUG), Gemcitabine (DRUG), Herceptin (DRUG).
Who is sponsoring clinical trial NCT00191451?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00191451's enrollment target sits among peer trials
150 455th of 2000 higher than 1,510 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
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