RecruitingPhase 1Phase 2NCT07612215

Elacestrant in Advanced Triple Positive Breast Cancer

Elacestrant in Advanced Triple Positive Breast Cancer, a Phase II Evaluation (ELATE)

Sponsor

NYU Langone Health

Enrollment

50 participants

Start Date

May 13, 2026

Study Type

INTERVENTIONAL

Conditions

ER Positive, HER2 Positive Breast Cancer

Summary

The purpose of this study to assess the safety and efficacy of elacestrant, a selective estrogen receptor degrader (SERD) and dual biologic therapy, trastuzumab and pertuzumab, in patients with triple-positive breast cancer with and without an ESR1 mutation.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Elacestrant, a drug called Pertuzumab, and others for people with er positive, her2 positive breast cancer. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGElacestrant

Elacestrant will be administered orally once daily at a dose of 345 mg daily.

DRUGTrastuzumab

Initial dose of trastuzumab is 8 mg/kg administered as a 90-minute intravenous infusion, followed every 3 weeks thereafter by a dose of 6 mg/kg administered as an intravenous infusion over 30 to 90 minutes.

DRUGPertuzumab

The initial dose of PERJETA is 840 mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by a dose of 420 mg administered as an intravenous infusion over 30 to 60 minutes.

Locations(1)

NYU Langone Health

New York, New York, United States

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NCT07612215