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NCT00426556 · ClinicalTrials.gov registry record · Phase 1
Efficacy and Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 88
- Enrollment target
NCT00426556: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT00426556 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 88 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00426556, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 88 participants
- Enrollment target
Study Summary
Phase I: will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer. Phase II: will assess the efficacy and safety of the 10mg daily dose of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer.
Primary Outcome
The primary objective of this phase II study was to evaluate the efficacy of the dose level/regimen of everolimus recommended from the Phase I with trastuzumab and paclitaxel (PT) therapy in patients with HER2-overexpressing metastatic breast cancer whose disease progressed on/after trastuzumab mono-and/or combination therapy based on the evaluation of objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Objective response rate (ORR) was defined as th
Interventions
- DRUG Trastuzumab
- DRUG Paclitaxel
- DRUG Everolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2007-07 |
| Est. Completion | 2014-03 |
| Phase | Phase 1 |
What the finished NCT00426556 record still lists
NCT00426556 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT00426556 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00426556 about?
NCT00426556 is a clinical study titled "Efficacy and Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer". Phase I: will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer. Phase II: will assess the efficacy and safety of the 10mg daily dose of everolimus combined with weekly tras...
What is the current status of trial NCT00426556?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 88 participants. The study started on 2007-07. Estimated completion is 2014-03.
What interventions are being tested in trial NCT00426556?
The interventions under investigation include: Trastuzumab (DRUG), Paclitaxel (DRUG), Everolimus (DRUG).
Who is sponsoring clinical trial NCT00426556?
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 NCT00426556's enrollment target sits among peer trials
88 650th of 2000 higher than 1,350 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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