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NCT03778931 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Trial of Elacestrant Versus Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
A Phase 3 study, sponsored by Stemline Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 478
- Enrollment target
NCT03778931: Completed Phase 3 study, sponsored by Stemline Therapeutics.
NCT03778931 is a Phase 3 study that has completed, run by Stemline Therapeutics. The registered enrollment target is 478 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03778931, a Phase 3 study, has completed, sponsored by Stemline Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 478 participants
- Enrollment target
Study Summary
This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI).
Primary Outcome
Progression-free survival based on blinded IRC assessment in ESR1-mut participants defined as the length of time from randomization until the date of objective disease progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as assessed by the blinded IRC or death from any cause. Progression is defined per RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Interventions
- DRUG Standard of Care
- DRUG Elacestrant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 478 participants |
| Start Date | 2019-05-10 |
| Est. Completion | 2024-08-22 |
| Phase | Phase 3 |
What the finished NCT03778931 record still lists
NCT03778931 is an interventional study that assigns participants to a tested intervention. The registered 478 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT03778931 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03778931 about?
NCT03778931 is a clinical study titled "Phase 3 Trial of Elacestrant Versus Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer". This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6 inhibitor in combination...
What is the current status of trial NCT03778931?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 478 participants. The study started on 2019-05-10. Estimated completion is 2024-08-22.
What interventions are being tested in trial NCT03778931?
The interventions under investigation include: Standard of Care (DRUG), Elacestrant (DRUG).
Who is sponsoring clinical trial NCT03778931?
This trial is sponsored by Stemline Therapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03778931's enrollment target sits among peer trials
478 805th of 2000 higher than 1,194 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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