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NCT00479856 · ClinicalTrials.gov registry record · Phase 2
Lapatinib In Combination With Chemotherapy In Subjects With Relapsed Breast Cancer
A Phase 2 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT00479856: Clinical Trial Phase 2 study, sponsored by GlaxoSmithKline.
NCT00479856 is a Phase 2 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00479856, a Phase 2 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of lapatinib in combination with chemotherapy (capecitabine, docetaxel, nab-paclitaxel) in subjects with ErbB2-overexpressing breast cancer whose disease has progressed during or within 12 months after completion of trastuzumab-containing therapy in the neoadjuvant or adjuvant setting.
Primary Outcome
Overall tumor response is defined as the percentage of participants with a confirmed complete or partial tumor response per Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is defined as the disappearance of all target lesions. CR could only be declared if all target and non-target lesions had disappeared. Partial response (PR) is defined as a decrease of 30% or greater in the sum of the longest diameter of target lesions.
Interventions
- DRUG Docetaxel
- DRUG Capecitabine
- DRUG Lapatinib
- DRUG nab-Paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2007-11 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
Why NCT00479856 stopped before completion
NCT00479856 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 4 interventions - of which Docetaxel is the first listed.
NCT00479856 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00479856 about?
NCT00479856 is a clinical study titled "Lapatinib In Combination With Chemotherapy In Subjects With Relapsed Breast Cancer". This study will evaluate the safety and efficacy of lapatinib in combination with chemotherapy (capecitabine, docetaxel, nab-paclitaxel) in subjects with ErbB2-overexpressing breast cancer whose disease has progressed during or within 12 months after completion of trastuzumab-containing therapy in t...
What is the current status of trial NCT00479856?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2007-11. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00479856?
The interventions under investigation include: Docetaxel (DRUG), Capecitabine (DRUG), Lapatinib (DRUG), nab-Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT00479856?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00479856's enrollment target sits among peer trials
9 1989th of 2000 higher than 11 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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