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NCT01783756 · ClinicalTrials.gov registry record · Phase 1
Phase 1b/2 Trial Using Lapatinib, Everolimus and Capecitabine for Treatment of HER-2 Positive Breast Cancer With CNS Metastasis
A Phase 1 study, sponsored by Jonsson Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01783756: Completed Phase 1 study, sponsored by Jonsson Comprehensive Cancer Center.
NCT01783756 is a Phase 1 study that has completed, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01783756, a Phase 1 study, has completed, sponsored by Jonsson Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This is a phase 1b/2 study to evaluate the safety and clinical activity of the combination of lapatinib, everolimus and capecitabine for the treatment of participants with HER2+ breast cancer with metastases in the brain who have progressed on trastuzumab. The combination of 2 drugs able to reach the brain (lapatinib and everolimus) that target different parts of the HER2 signaling pathway plus chemotherapy (capecitabine) that has proven benefits in metastatic breast cancer may lead to improved clinical outcomes for participants with CNS metastasis. Participants will undergo brain MRIs and CT scans of the chest and abdomen to evaluate response to the treatment, regular laboratory tests and echocardiogram or Multi Gated Acquisition Scan (MUGA) to assess cardiac activity
Primary Outcome
Estimated with a 95% confidence interval. Chi-square test will be used evaluate if the CNS response rate at week 12 is significantly higher than 20%.
Interventions
- OTHER laboratory biomarker analysis
- DRUG capecitabine
- DRUG everolimus
- DRUG lapatinib ditosylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2013-06-26 |
| Est. Completion | 2019-05-10 |
| Phase | Phase 1 |
What the finished NCT01783756 record still lists
NCT01783756 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT01783756 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01783756 about?
NCT01783756 is a clinical study titled "Phase 1b/2 Trial Using Lapatinib, Everolimus and Capecitabine for Treatment of HER-2 Positive Breast Cancer With CNS Metastasis". This is a phase 1b/2 study to evaluate the safety and clinical activity of the combination of lapatinib, everolimus and capecitabine for the treatment of participants with HER2+ breast cancer with metastases in the brain who have progressed on trastuzumab. The combination of 2 drugs able to reach t...
What is the current status of trial NCT01783756?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2013-06-26. Estimated completion is 2019-05-10.
What interventions are being tested in trial NCT01783756?
The interventions under investigation include: laboratory biomarker analysis (OTHER), capecitabine (DRUG), everolimus (DRUG), lapatinib ditosylate (DRUG).
Who is sponsoring clinical trial NCT01783756?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01783756's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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