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NCT00272987 · ClinicalTrials.gov registry record · Phase 3
ErbB2 Over-expressing Metastatic Breast Cancer Study Using Paclitaxel, Trastuzumab, and Lapatinib
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 63
- Enrollment target
NCT00272987: Clinical Trial Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00272987 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 63 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00272987, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 63 participants
- Enrollment target
Study Summary
This study was originally designed as a Phase III randomized, double blind, placebo controlled study to assess the safety and tolerability, and efficacy of paclitaxel plus trastuzumab plus lapatinib compared with paclitaxel plus trastuzumab plus placebo in women with ErbB2 overexpressing metastatic breast cancer. The planned study was a two stage design with an initial open-label safety stage to be conducted in approximately 65 subjects followed by a randomized phase conducted in a further 700 subjects. The open-label part of the study sequentially enrolled three cohorts with patients receiving a different dose combination of paclitaxel, trastuzumab and lapatinib. Following poor recruitment rate in the open label stage, the randomized stage of the study was terminated, thus no subjects were enrolled into the randomization stage.
Primary Outcome
Extent of exposure is defined as the duration of the treatment administered during the study. The mean duration of exposure to lapatinib, trastuzumab and paclitaxel is calculated as the number of weeks between the start and end of treatment.
Interventions
- DRUG trastuzumab
- DRUG paclitaxel
- DRUG lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2005-12-13 |
| Est. Completion | 2019-10-21 |
| Phase | Phase 3 |
Why NCT00272987 stopped before completion
NCT00272987 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which trastuzumab is the first listed.
NCT00272987 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00272987 about?
NCT00272987 is a clinical study titled "ErbB2 Over-expressing Metastatic Breast Cancer Study Using Paclitaxel, Trastuzumab, and Lapatinib". This study was originally designed as a Phase III randomized, double blind, placebo controlled study to assess the safety and tolerability, and efficacy of paclitaxel plus trastuzumab plus lapatinib compared with paclitaxel plus trastuzumab plus placebo in women with ErbB2 overexpressing metastatic ...
What is the current status of trial NCT00272987?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 63 participants. The study started on 2005-12-13. Estimated completion is 2019-10-21.
What interventions are being tested in trial NCT00272987?
The interventions under investigation include: trastuzumab (DRUG), paclitaxel (DRUG), lapatinib (DRUG).
Who is sponsoring clinical trial NCT00272987?
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 NCT00272987's enrollment target sits among peer trials
63 1800th of 2000 higher than 199 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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