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NCT04647487 · ClinicalTrials.gov registry record · Phase 1
A Study of LY3484356 in Women With Breast Cancer Before Having Surgery
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 87
- Enrollment target
NCT04647487: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT04647487 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 87 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04647487, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 87 participants
- Enrollment target
Study Summary
The purpose for this study is to see if the study drug, LY3484356, is safe and to determine what effects it has on breast cancer in participants with Estrogen Receptor Positive (ER+), HER2 Negative (HER2-) early stage (stage I-III) breast cancer, when given prior to surgery. Participation in this study could last up to 2.5 months.
Primary Outcome
Tumor tissue collected by biopsy is used to determine ER expression. ER expression is measured by immunohistochemistry (IHC) and quantified by H-score. The H-score was calculated as the sum of multiplying the tumor cell ER staining intensity level 0 to 3 (0=none, 1=low, 2=moderate, 3=high) by the percentage (0 to 100) of cells at each intensity. Total ER H-score ranged from 0 to 300, where a higher score indicated stronger ER expression. Percent change in ER expression was defined as 100\*(ER ex
Interventions
- DRUG LY3484356
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2021-04-21 |
| Est. Completion | 2022-11-11 |
| Phase | Phase 1 |
What the finished NCT04647487 record still lists
NCT04647487 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% higher).
The record links to 0 conditions, and to 1 intervention - of which LY3484356 is the first listed.
NCT04647487 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04647487 about?
NCT04647487 is a clinical study titled "A Study of LY3484356 in Women With Breast Cancer Before Having Surgery". The purpose for this study is to see if the study drug, LY3484356, is safe and to determine what effects it has on breast cancer in participants with Estrogen Receptor Positive (ER+), HER2 Negative (HER2-) early stage (stage I-III) breast cancer, when given prior to surgery. Participation in this st...
What is the current status of trial NCT04647487?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 87 participants. The study started on 2021-04-21. Estimated completion is 2022-11-11.
What interventions are being tested in trial NCT04647487?
The interventions under investigation include: LY3484356 (DRUG).
Who is sponsoring clinical trial NCT04647487?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04647487's enrollment target sits among peer trials
87 651st of 2000 higher than 1,349 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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