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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 is a Phase 3 study that has completed, run by Stemline Therapeutics. The registered enrollment target is 478 participants.

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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).

Interventions

  • DRUG Standard of Care
  • DRUG Elacestrant

Trial Details

FieldValue
Enrollment Target 478 participants
Start Date 2019-05-10
Est. Completion 2024-08-22
Phase Phase 3

Sponsor

Stemline Therapeutics

17 total trials

What the Registry Record Tells You About NCT03778931

The ClinicalTrials.gov registry entry for NCT03778931 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 478 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stemline Therapeutics, which has 17 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.

NCT03778931 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.