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NCT01688609 · ClinicalTrials.gov registry record · Phase 2
Lapatinib Ditosylate, Trastuzumab, Paclitaxel, and Surgery in Treating Patients With Breast Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT01688609: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01688609 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01688609, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
This phase II trial studies how well giving lapatinib ditosylate together with trastuzumab, paclitaxel, and surgery works in treating patients with breast cancer. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Primary Outcome
For biomarkers ALDH1 and CD44v, the change in the proportions of CD44v-positive (CD44v+) tumor cells and ALDH1-positive (ALDH1+) tumor cells in tumor tissue from baseline to 6 weeks and 18 weeks time points were determined for each patient. For biomarker change, changes in the binary biomarkers between time points were assessed using McNemar's test in all patients and separately in patients with and without pCR.
Interventions
- DRUG paclitaxel
- PROCEDURE therapeutic conventional surgery
- OTHER pharmacological study
- BIOLOGICAL trastuzumab
- DRUG lapatinib ditosylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2012-07 |
| Est. Completion | 2016-08-15 |
| Phase | Phase 2 |
What the finished NCT01688609 record still lists
NCT01688609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 5 interventions - of which paclitaxel is the first listed.
NCT01688609 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01688609 about?
NCT01688609 is a clinical study titled "Lapatinib Ditosylate, Trastuzumab, Paclitaxel, and Surgery in Treating Patients With Breast Cancer". This phase II trial studies how well giving lapatinib ditosylate together with trastuzumab, paclitaxel, and surgery works in treating patients with breast cancer. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, su...
What is the current status of trial NCT01688609?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2012-07. Estimated completion is 2016-08-15.
What interventions are being tested in trial NCT01688609?
The interventions under investigation include: paclitaxel (DRUG), therapeutic conventional surgery (PROCEDURE), pharmacological study (OTHER), trastuzumab (BIOLOGICAL), lapatinib ditosylate (DRUG).
Who is sponsoring clinical trial NCT01688609?
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 NCT01688609's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 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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