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NCT02236000 · ClinicalTrials.gov registry record · Phase 1
A Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) With Neratinib in Women With Metastatic HER2-Positive Breast Cancer
A Phase 1 study, sponsored by NSABP Foundation.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT02236000 is a Phase 1 study that has completed, run by NSABP Foundation. The registered enrollment target is 49 participants.
The verdict
NCT02236000, a Phase 1 study, has completed, sponsored by NSABP Foundation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study Summary
This study is being done for the following reasons: * The study has two parts. The purpose of the first part (Phase I) of the study is to find out the highest dose of neratinib that can be given safely with T-DM1. * The purpose of the second part of the study (Phase II) is to find out whether the dose of neratinib with T-DM1 determined in Phase I will keep breast cancer from getting worse for a period of time. * In order to learn more about study therapy levels in blood and discover genetic and protein changes associated with cancer, the study includes special research tests using samples from blood and from breast tumor. Blood samples will be collected before study treatment, once during treatment, and after study treatment stops. * In the optional part of this study, three biopsies will be performed to obtain fresh tumor samples from an area where your cancer has spread.
Interventions
- DRUG Neratinib
- DRUG T-DM1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2014-08 |
| Est. Completion | 2021-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02236000
The ClinicalTrials.gov registry entry for NCT02236000 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NSABP Foundation, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Neratinib is the first listed.
NCT02236000 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02236000 about?
NCT02236000 is a clinical study titled "A Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) With Neratinib in Women With Metastatic HER2-Positive Breast Cancer". This study is being done for the following reasons: * The study has two parts. The purpose of the first part (Phase I) of the study is to find out the highest dose of neratinib that can be given safely with T-DM1. * The purpose of the second part of the study (Phase II) is to find out whether the d...
What is the current status of trial NCT02236000?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2014-08. Estimated completion is 2021-08.
What interventions are being tested in trial NCT02236000?
The interventions under investigation include: Neratinib (DRUG), T-DM1 (DRUG).
Who is sponsoring clinical trial NCT02236000?
This trial is sponsored by NSABP Foundation, which has 44 total clinical trials registered on ClinicalTrials.gov.
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