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NCT03767335 · ClinicalTrials.gov registry record · Phase 1
MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer
A Phase 1 study, sponsored by Menarini Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT03767335: Completed Phase 1 study, sponsored by Menarini Group.
NCT03767335 is a Phase 1 study that has completed, run by Menarini Group. The registered enrollment target is 62 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03767335, a Phase 1 study, has completed, sponsored by Menarini Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study Summary
The main purpose of this open-label, dose-escalation, phase Ib study is to identify the appropriate dose of MEN1611 to be used in combination with Trastuzumab with/without Fulvestrant for the treatment of advanced or metastatic HER2-positive breast cancer
Primary Outcome
MTD was defined as the highest dose level at which no more than 1 participant experienced a DLT during the 28-day DLT assessment window.
Interventions
- DRUG Trastuzumab
- DRUG Fulvestrant
- DRUG MEN1611
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2018-11-13 |
| Est. Completion | 2024-02-23 |
| Phase | Phase 1 |
What the finished NCT03767335 record still lists
NCT03767335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT03767335 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03767335 about?
NCT03767335 is a clinical study titled "MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer". The main purpose of this open-label, dose-escalation, phase Ib study is to identify the appropriate dose of MEN1611 to be used in combination with Trastuzumab with/without Fulvestrant for the treatment of advanced or metastatic HER2-positive breast cancer
What is the current status of trial NCT03767335?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2018-11-13. Estimated completion is 2024-02-23.
What interventions are being tested in trial NCT03767335?
The interventions under investigation include: Trastuzumab (DRUG), Fulvestrant (DRUG), MEN1611 (DRUG).
Who is sponsoring clinical trial NCT03767335?
This trial is sponsored by Menarini Group, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03767335's enrollment target sits among peer trials
62 824th of 2000 higher than 1,173 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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