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NCT01007942 · ClinicalTrials.gov registry record · Phase 3
Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 569
- Enrollment target
NCT01007942: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01007942 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 569 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01007942, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 569 participants
- Enrollment target
Study Summary
This phase III, double-blind, placebo-controlled multinational study will assess the combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine and trastuzumab with respect to progressive-free survival and over survival in HER2/neu positive women with locally advanced or metastatic breast cancer who are resistant to trastuzumab and have been pre-treated with a taxane.
Primary Outcome
PFS was defined as the time from the date of randomization to the date of first radiologically documented tumor progression or death from any cause, whichever occurs first. PFS primary analysis performed when 415 events were reached. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Interventions
- DRUG Placebo
- DRUG trastuzumab
- DRUG vinorelbine
- DRUG everolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 569 participants |
| Start Date | 2009-10 |
| Est. Completion | 2015-06 |
| Phase | Phase 3 |
What the finished NCT01007942 record still lists
NCT01007942 is an interventional study that assigns participants to a tested intervention. The registered 569 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01007942 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01007942 about?
NCT01007942 is a clinical study titled "Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer". This phase III, double-blind, placebo-controlled multinational study will assess the combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine and trastuzumab with respect to progressive-free survival and over survival in HER2/neu positive women with locally advanc...
What is the current status of trial NCT01007942?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 569 participants. The study started on 2009-10. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01007942?
The interventions under investigation include: Placebo (DRUG), trastuzumab (DRUG), vinorelbine (DRUG), everolimus (DRUG).
Who is sponsoring clinical trial NCT01007942?
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 NCT01007942's enrollment target sits among peer trials
569 666th of 2000 higher than 1,335 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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