Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 9 participants.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01783756
The ClinicalTrials.gov registry entry for NCT01783756 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jonsson Comprehensive Cancer Center, which has 321 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT01783756 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.