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NCT02980341 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer
A Phase 1 study, sponsored by Daiichi Sankyo Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 182
- Enrollment target
NCT02980341: Completed Phase 1 study, sponsored by Daiichi Sankyo Co..
NCT02980341 is a Phase 1 study that has completed, run by Daiichi Sankyo Co.. The registered enrollment target is 182 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (203% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02980341, a Phase 1 study, has completed, sponsored by Daiichi Sankyo Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 182 participants
- Enrollment target
Study Summary
This is an open-label, three-part, multiple-dose study to evaluate safety, tolerability, and efficacy of U3-1402 in patients with HER3-positive metastatic breast cancer. HER3 is a unique member of the human epidermal growth factor receptor, which defines a certain type of cancer. The number of patients and treatment cycles are not fixed in this study. Subjects who continue to derive clinical benefit from the study treatment in the absence of withdrawal of consent, progressive disease (PD), unacceptable toxicity, or death may continue the study treatment until the end of the trial.
Primary Outcome
AEs will be collected systematically from signing of the informed consent form (ICF) through 28 days after last dose
Interventions
- DRUG Patritumab Deruxtecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2016-11-28 |
| Est. Completion | 2023-09-07 |
| Phase | Phase 1 |
What the finished NCT02980341 record still lists
NCT02980341 is an interventional study that assigns participants to a tested intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (203% higher).
The record links to 0 conditions, and to 1 intervention - of which Patritumab Deruxtecan is the first listed.
NCT02980341 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02980341 about?
NCT02980341 is a clinical study titled "Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer". This is an open-label, three-part, multiple-dose study to evaluate safety, tolerability, and efficacy of U3-1402 in patients with HER3-positive metastatic breast cancer. HER3 is a unique member of the human epidermal growth factor receptor, which defines a certain type of cancer. The number of pati...
What is the current status of trial NCT02980341?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 182 participants. The study started on 2016-11-28. Estimated completion is 2023-09-07.
What interventions are being tested in trial NCT02980341?
The interventions under investigation include: Patritumab Deruxtecan (DRUG).
Who is sponsoring clinical trial NCT02980341?
This trial is sponsored by Daiichi Sankyo Co., which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02980341's enrollment target sits among peer trials
182 299th of 2000 higher than 1,702 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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