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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: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT00829166 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 991 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PD was assessed by an IRC using modified Response Evaluation Criteria in Solid Tumors (RECIST). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as target lesions (TLs) and recorded at baseline. TLs should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements either by imaging or clinically. A sum of the longest diameter for all TLs was calculated as baseline sum longest diameter (SLD
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 |
What the finished NCT00829166 record still lists
NCT00829166 is an interventional study that assigns participants to a tested intervention. The registered 991 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% higher).
The record links to 0 conditions, and to 3 interventions - of which Capecitabine is the first listed.
NCT00829166 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00829166's enrollment target sits among peer trials
991 315th of 2000 higher than 1,686 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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