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Phase 3 Trial of Elacestrant Versus Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

NCT03778931 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2025-09-15

Study results available
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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).

Conditions

Interventions

DRUG

Elacestrant

400 mg/day once daily oral dosing

DRUG

Standard of Care

* Fulvestrant: 500 mg administered intramuscularly (IM) into the buttocks as two 5 mL injections on C1D1, C1D15 and C2D1 and Day 1 of every subsequent 28-day cycle * Anastrozole 1 mg/day on a continuous dosing schedule * Letrozole: 2.5 mg/day on a continuous dosing schedule * Exemestane: 25 mg/day on a continuous dosing schedule

Sponsors & Collaborators

  • Stemline Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-10
Primary Completion
2021-08-24
Completion
2024-08-22
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Canada
  • Denmark
  • France
  • Greece
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Portugal
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03778931 on ClinicalTrials.gov