MedTrace Logo

Elacestrant in Advanced Triple Positive Breast Cancer

NCT07612215 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-28

No results posted yet for this study

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.

Conditions

  • ER Positive, HER2 Positive Breast Cancer

Interventions

DRUG

Elacestrant

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

DRUG

Trastuzumab

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.

DRUG

Pertuzumab

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.

Sponsors & Collaborators

Principal Investigators

  • Douglas K Marks, MD · NYU Langone Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-13
Primary Completion
2029-05-31
Completion
2030-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT07612215 on ClinicalTrials.gov