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RecruitingPhase 2NCT06062498

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

Randomized Phase II Study of Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor (Palbociclib, Abemaciclib, or Ribociclib) in Patients With ER+/HER2- Advanced or Metastatic Breast Cancer With Prior Exposure to a CKD4/6 Inhibitor

Sponsor

Northwestern University

Enrollment

174 participants

Start Date

Sep 29, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Breast CancerEstrogen Receptor-positive Breast CancerHER2/Neu-Negative Breast CancerAdvanced Breast Cancerv

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing elacestrant (a hormone-blocking oral pill) alone versus elacestrant combined with a CDK4/6 inhibitor (a targeted therapy drug) in patients with ER-positive, HER2-negative breast cancer that has spread and progressed on prior treatment. **You may be eligible if...** - You have been diagnosed with ER-positive, HER2-negative advanced or metastatic breast cancer confirmed by biopsy - Your cancer has progressed after prior hormone therapy and/or CDK4/6 inhibitor treatment - You have measurable disease or bone-only metastases **You may NOT be eligible if...** - Your cancer is HER2-positive or ER-negative - You have not had prior treatment for metastatic breast cancer - You have certain serious medical conditions affecting your heart or liver Talk to your doctor to see if this trial is right for you.

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, palbociclib, abemaciclib, ribociclib

Given orally

Locations(1)

Northwestern University

Chicago, Illinois, United States

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NCT06062498

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