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Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer

NCT06062498 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2025-10-17

No results posted yet for this study

Summary

Breast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women. Estrogen receptor-positive and HER2-negative breast cancer is the most prevalent breast cancer subtype. Endocrine therapy is the mainstay of treatment; however, due to the varied nature of the disease, development of resistance to this therapeutic approach is very common in the metastatic setting.

The purpose of this study is to see whether the effectiveness of elacestrant can be enhanced by combining it with a targeted agent such as a CDK4/6 inhibitor to treat patients with ER+/HER2- or metastatic breast cancer with prior exposure to a CDK4/6 inhibitor.

Conditions

  • Estrogen-receptor-positive Breast Cancer
  • HER2/Neu-Negative Breast Cancer
  • Advanced Breast Cancerv
  • Metastatic Breast Cancer

Interventions

DRUG

elacestrant, palbociclib, abemaciclib, ribociclib

Given orally

Sponsors & Collaborators

Principal Investigators

  • William Gradishar, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-29
Primary Completion
2026-07-01
Completion
2027-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT06062498 on ClinicalTrials.gov