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NCT04432454 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
A Phase 2 study, sponsored by Sermonix Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT04432454: Completed Phase 2 study, sponsored by Sermonix Pharmaceuticals.
NCT04432454 is a Phase 2 study that has completed, run by Sermonix Pharmaceuticals. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04432454, a Phase 2 study, has completed, sponsored by Sermonix Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
Study Summary
This is an open-label, multicenter, single-arm safety study evaluating the safety and tolerability of the lasofoxifene and abemaciclib combination for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on first and/or 2nd lines of hormonal treatment for metastatic disease and have an ESR1 mutation.
Primary Outcome
AEs will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Interventions
- DRUG Lasofoxifene and abemaciclib (VERZENIO (R)).
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2020-09-29 |
| Est. Completion | 2025-01-28 |
| Phase | Phase 2 |
What the finished NCT04432454 record still lists
NCT04432454 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which Lasofoxifene and abemaciclib (VERZENIO (R)). is the first listed.
NCT04432454 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04432454 about?
NCT04432454 is a clinical study titled "Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation". This is an open-label, multicenter, single-arm safety study evaluating the safety and tolerability of the lasofoxifene and abemaciclib combination for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on first and/...
What is the current status of trial NCT04432454?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2020-09-29. Estimated completion is 2025-01-28.
What interventions are being tested in trial NCT04432454?
The interventions under investigation include: Lasofoxifene and abemaciclib (VERZENIO (R)). (DRUG).
Who is sponsoring clinical trial NCT04432454?
This trial is sponsored by Sermonix Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04432454's enrollment target sits among peer trials
29 1669th of 2000 higher than 324 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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