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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: Completed Phase 1 study, sponsored by NSABP Foundation.
NCT02236000 is a Phase 1 study that has completed, run by NSABP Foundation. The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
If 1 of 3 patients in this cohort experiences a dose limiting toxicity (DLT), 3 more patients will be added at the same dose level. If 0 of 3 initial patients or 1 of 6 patients in an expanded cohort experiences a DLT, the dose for the next cohort will be escalated to dose level 2; otherwise, the combination will be considered too toxic.
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 |
What the finished NCT02236000 record still lists
NCT02236000 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 2 interventions - of which Neratinib is the first listed.
NCT02236000 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02236000's enrollment target sits among peer trials
49 1017th of 2000 higher than 976 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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