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NCT00444535 · ClinicalTrials.gov registry record · Phase 2
Lapatinib and Bevacizumab for Metastatic Breast Cancer
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT00444535: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT00444535 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00444535, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with ErbB2-overexpressing breast cancer.
Primary Outcome
The PFS rate is defined as the percentage of subjects who have shown no evidence of disease progression or death from any cause following 12 weeks of treatment. Disease 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. Since there is no independent reviewer, only the investigator response was re
Interventions
- DRUG bevacizumab
- DRUG lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2007-02-27 |
| Est. Completion | 2020-06-19 |
| Phase | Phase 2 |
What the finished NCT00444535 record still lists
NCT00444535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which bevacizumab is the first listed.
NCT00444535 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00444535 about?
NCT00444535 is a clinical study titled "Lapatinib and Bevacizumab for Metastatic Breast Cancer". This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with ErbB2-overexpressing breast cancer.
What is the current status of trial NCT00444535?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2007-02-27. Estimated completion is 2020-06-19.
What interventions are being tested in trial NCT00444535?
The interventions under investigation include: bevacizumab (DRUG), lapatinib (DRUG).
Who is sponsoring clinical trial NCT00444535?
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 NCT00444535's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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