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NCT00470704 · ClinicalTrials.gov registry record · Phase 2
Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive, Metastatic Breast Cancer
A Phase 2 study, sponsored by Nancy Lin, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 87
- Enrollment target
NCT00470704: Completed Phase 2 study, sponsored by Nancy Lin, MD.
NCT00470704 is a Phase 2 study that has completed, run by Nancy Lin, MD. The registered enrollment target is 87 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00470704, a Phase 2 study, has completed, sponsored by Nancy Lin, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 87 participants
- Enrollment target
Study Summary
In this research study we are studying the effects of the combination of lapatinib plus Herceptin in subjects with breast cancer that has spread outside of the breast. We are also studying whether positron emission tomography (PET/CT) scans can predict which participants will benefit from the study treatment. Finally, we are studying genes and proteins in the tumor tissue that may lead to sensitivity or resistance to Herceptin, and to the combination of Herceptin plus lapatinib. Lapatinib is a compound that may stop cancer cells from growing. Other research studies suggest that lapatinib in combination with Herceptin may help to shrink or stabilize breast cancer.
Primary Outcome
The objective response rate is the percentage of participants achieving complete response (CR) or partial response (PR) as the best response recorded on treatment based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria. CR and PR must meet the following lesion criteria without having any new lesions as well: Target Lesion: (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<1
Interventions
- DRUG Lapatinib
- DRUG Herceptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2007-05-14 |
| Est. Completion | 2024-08-20 |
| Phase | Phase 2 |
What the finished NCT00470704 record still lists
NCT00470704 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 2 interventions - of which Lapatinib is the first listed.
NCT00470704 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00470704 about?
NCT00470704 is a clinical study titled "Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive, Metastatic Breast Cancer". In this research study we are studying the effects of the combination of lapatinib plus Herceptin in subjects with breast cancer that has spread outside of the breast. We are also studying whether positron emission tomography (PET/CT) scans can predict which participants will benefit from the study ...
What is the current status of trial NCT00470704?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 87 participants. The study started on 2007-05-14. Estimated completion is 2024-08-20.
What interventions are being tested in trial NCT00470704?
The interventions under investigation include: Lapatinib (DRUG), Herceptin (DRUG).
Who is sponsoring clinical trial NCT00470704?
This trial is sponsored by Nancy Lin, MD, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00470704's enrollment target sits among peer trials
87 810th of 2000 higher than 1,189 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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