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ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer

NCT07198724 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-04-09

No results posted yet for this study

Summary

The goal of this study is to evaluate the safety and efficacy of elacestrant in combination with trastuzumab deruxtecan (T-DXd) in participants with hormone receptor-positive (HR+), HER2-low or HER2-ultralow, metastatic breast cancer that is resistant to prior CDK4/6 inhibitor and endocrine therapy.

The names of the study drugs involved in this study are:

* Elacestrant (a type of selective estrogen receptor degrader)
* Trastuzumab deruxtecan (a type of standard of care antibody drug conjugate)

Conditions

Interventions

DRUG

Elacestrant

Selective estrogen receptor degrader (SERD), film-coated tablet, taken orally per protocol.

DRUG

Trastuzumab Deruxtecan

HER2-directed antibody-drug conjugate, vial, via intravenous (into the vein) infusion per standard of care

Sponsors & Collaborators

  • Stemline Therapeutics, Inc.

    collaborator INDUSTRY

  • Sarah Sammons, MD

    lead OTHER

Principal Investigators

  • Sarah Sammons, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-17
Primary Completion
2028-06-01
Completion
2038-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT07198724 on ClinicalTrials.gov