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NCT00876395 · ClinicalTrials.gov registry record · Phase 3
Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 719
- Enrollment target
NCT00876395: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00876395 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 719 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00876395, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 719 participants
- Enrollment target
Study Summary
The purpose of this Phase III study was to confirm the value of adding everolimus to weekly paclitaxel and trastuzumab as treatment of HER2-overexpressing metastatic breast cancer.
Primary Outcome
PFS is defined as the time from the date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first. This was assessed in the full patient population.
Interventions
- DRUG Trastuzumab
- DRUG Placebo
- DRUG Paclitaxel
- DRUG Everolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 719 participants |
| Start Date | 2009-09-10 |
| Est. Completion | 2017-10-23 |
| Phase | Phase 3 |
What the finished NCT00876395 record still lists
NCT00876395 is an interventional study that assigns participants to a tested intervention. The registered 719 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Trastuzumab is the first listed.
NCT00876395 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00876395 about?
NCT00876395 is a clinical study titled "Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer". The purpose of this Phase III study was to confirm the value of adding everolimus to weekly paclitaxel and trastuzumab as treatment of HER2-overexpressing metastatic breast cancer.
What is the current status of trial NCT00876395?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 719 participants. The study started on 2009-09-10. Estimated completion is 2017-10-23.
What interventions are being tested in trial NCT00876395?
The interventions under investigation include: Trastuzumab (DRUG), Placebo (DRUG), Paclitaxel (DRUG), Everolimus (DRUG).
Who is sponsoring clinical trial NCT00876395?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00876395's enrollment target sits among peer trials
719 498th of 2000 higher than 1,503 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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