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NCT00829166 · ClinicalTrials.gov registry record · Phase 3
A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 991
- Enrollment target
NCT00829166 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 991 participants.
The verdict
NCT00829166, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 991 participants
- Enrollment target
Study Summary
This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib in participants with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination. Once disease progression is reported, all participants will be followed for survival every 3 months until death, loss to follow-up, withdrawal of consent, or study termination.
Interventions
- DRUG Capecitabine
- DRUG Trastuzumab emtansine
- DRUG Lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 991 participants |
| Start Date | 2009-02 |
| Est. Completion | 2015-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00829166
The ClinicalTrials.gov registry entry for NCT00829166 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 991 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Capecitabine is the first listed.
NCT00829166 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00829166 about?
NCT00829166 is a clinical study titled "A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer". This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib in participants with human epidermal growth factor receptor 2 (HER2)-positive locally advan...
What is the current status of trial NCT00829166?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 991 participants. The study started on 2009-02. Estimated completion is 2015-09.
What interventions are being tested in trial NCT00829166?
The interventions under investigation include: Capecitabine (DRUG), Trastuzumab emtansine (DRUG), Lapatinib (DRUG).
Who is sponsoring clinical trial NCT00829166?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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