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NCT02658084 · ClinicalTrials.gov registry record · Phase 1
Vinorelbine With Trastuzumab Emtansine in Pre-Treated HER2-Positive Metastatic Breast Cancer
A Phase 1 study, sponsored by University of Miami.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT02658084: Clinical Trial Phase 1 study, sponsored by University of Miami.
NCT02658084 is a Phase 1 study that was terminated before completion, run by University of Miami. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02658084, a Phase 1 study, was terminated before completion, sponsored by University of Miami.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
The study proposes to evaluate the safety and efficacy of the combination of trastuzumab emtansine (T-DM1) and vinorelbine in HER2+ metastatic breast cancer patients.
Primary Outcome
Identifying the Maximum Tolerated Dose (MTD) of Vinorelbine combined with a fixed dose of Trastuzumab Emtansine to be recommended for the phase II portion of the study (RP2D).
Interventions
- DRUG Vinorelbine
- DRUG Trastuzumab Emtansine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2017-04-12 |
| Est. Completion | 2018-10-11 |
| Phase | Phase 1 |
Why NCT02658084 stopped before completion
NCT02658084 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Vinorelbine is the first listed.
NCT02658084 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02658084 about?
NCT02658084 is a clinical study titled "Vinorelbine With Trastuzumab Emtansine in Pre-Treated HER2-Positive Metastatic Breast Cancer". The study proposes to evaluate the safety and efficacy of the combination of trastuzumab emtansine (T-DM1) and vinorelbine in HER2+ metastatic breast cancer patients.
What is the current status of trial NCT02658084?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2017-04-12. Estimated completion is 2018-10-11.
What interventions are being tested in trial NCT02658084?
The interventions under investigation include: Vinorelbine (DRUG), Trastuzumab Emtansine (DRUG).
Who is sponsoring clinical trial NCT02658084?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02658084's enrollment target sits among peer trials
2 2000th of 2000 the lowest 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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