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A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer

NCT07766018 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-08-14

No results posted yet for this study

Summary

This is a multicenter, open-label, Phase 2 bridging study to evaluate the efficacy and safety of elacestrant in Japanese post-menopausal women and men with estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer with estrogen receptor 1 gene mutation (ESR1-mut) whose disease has relapsed or progressed on at least 1 and no more than 2 prior lines of endocrine therapy for metastatic breast cancer, which must have included cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) therapy in combination with fulvestrant or an aromatase inhibitor.

Conditions

  • ER+/HER2- Advanced or Metastatic Breast Cancer

Interventions

DRUG

Elacestrant

Administered as an oral tablet

Sponsors & Collaborators

  • Stemline Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Stemline Therapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-10-31
Completion
2028-10-31
FDA Drug
Yes

Countries

  • Japan

Study Locations

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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 NCT07766018 on ClinicalTrials.gov