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NCT00191152 · ClinicalTrials.gov registry record · Phase 3
A Phase III Trial For Patients With Metastatic Breast Cancer
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 475
- Enrollment target
NCT00191152 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 475 participants.
The verdict
NCT00191152, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 475 participants
- Enrollment target
Study Summary
This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/ capecitabine doublets, with crossover to the alternate agent. The experimental arm will receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75 mg/m2 IV day 1 over 1 hour repeated every three weeks. The comparator arm will receive docetaxel 75 mgm/m2 IV day 1 over 1 hour and oral capecitabine 1000 mg/m2 twice daily, days 1 through 14 repeated every three weeks. Patients who progress on the experimental arm, will be treated with capecitabine as dosed on the comparator arm. Patients who progress on the comparator arm will be treated with gemcitabine as dosed on the experimental arm.
Interventions
- DRUG docetaxel
- DRUG gemcitabine
- DRUG capecitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 475 participants |
| Start Date | 2002-02 |
| Est. Completion | 2008-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00191152
The ClinicalTrials.gov registry entry for NCT00191152 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 475 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which docetaxel is the first listed.
NCT00191152 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00191152 about?
NCT00191152 is a clinical study titled "A Phase III Trial For Patients With Metastatic Breast Cancer". This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/ capecitabine doublets, with crossover to the alternate agent. The experimental arm will receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75 mg/m2 IV day 1 over 1 hour repea...
What is the current status of trial NCT00191152?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 475 participants. The study started on 2002-02. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00191152?
The interventions under investigation include: docetaxel (DRUG), gemcitabine (DRUG), capecitabine (DRUG).
Who is sponsoring clinical trial NCT00191152?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
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