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NCT00770809 · ClinicalTrials.gov registry record · Phase 3
Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 305
- Enrollment target
NCT00770809: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT00770809 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 305 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00770809, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 305 participants
- Enrollment target
Study Summary
This randomized phase III trial studies paclitaxel and trastuzumab with or without lapatinib to see how well they work in treating patients with stage II or stage III breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel with trastuzumab and/or lapatinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which regimen is more effective in treating patients with breast cancer.
Primary Outcome
Complete pathological response is defined as the absence of residual invasive carcinoma in the breast at the time of definitive surgical removal. Pathologic complete response in the lymph nodes is defined as no detectable invasive tumor by H\&E. Analysis will use a chi-square test for the difference in proportions of patients on the THL arm versus the TH arm who achieve a pCR. Exact binomial methods will be used to construct 95% confidence intervals around the pCR incidence for each arm.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Paclitaxel
- BIOLOGICAL Trastuzumab
- DRUG Lapatinib Ditosylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 305 participants |
| Start Date | 2009-02-24 |
| Est. Completion | 2024-02-15 |
| Phase | Phase 3 |
What the finished NCT00770809 record still lists
NCT00770809 is an interventional study that assigns participants to a tested intervention. The registered 305 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00770809 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00770809 about?
NCT00770809 is a clinical study titled "Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery". This randomized phase III trial studies paclitaxel and trastuzumab with or without lapatinib to see how well they work in treating patients with stage II or stage III breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the grow...
What is the current status of trial NCT00770809?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 305 participants. The study started on 2009-02-24. Estimated completion is 2024-02-15.
What interventions are being tested in trial NCT00770809?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), Trastuzumab (BIOLOGICAL), Lapatinib Ditosylate (DRUG).
Who is sponsoring clinical trial NCT00770809?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00770809's enrollment target sits among peer trials
305 1117th of 2000 higher than 884 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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