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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

What is this study?

This study is testing if adding a targeted medicine (a CDK4/6 inhibitor) to a hormone therapy called elacestrant works better than using elacestrant alone. It aims to help patients whose breast cancer has stopped responding to their previous treatments.

Who can participate?

You may be eligible if you have ER+/HER2- breast cancer that has spread, have an ESR1 gene mutation, and have previously been treated with hormone therapy and a CDK4/6 inhibitor. Your doctor will need to confirm your specific tumor type and treatment history.

What will happen?

Participants will be randomly assigned to receive either elacestrant alone or a combination of elacestrant and a CDK4/6 inhibitor. You will be closely monitored by the research team to track your health and how the cancer responds to the medication.

Where and when?

The study is currently recruiting participants and is located in Chicago, Illinois. You should talk with your oncologist to see if this location and trial are a good fit for your personal care plan.

Key Points
  • 1Tests a combination treatment strategy for advanced breast cancer.
  • 2Requires participants to have a specific genetic marker called an ESR1 mutation.
  • 3Designed for patients who have already tried other common hormone-based therapies.

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Conditions Studied
This study is investigating treatments for the following conditions
Estrogen-receptor-positive Breast CancerHER2/Neu-Negative Breast CancerAdvanced Breast CancervMetastatic Breast Cancer

This summary was generated using AI and may not capture all details. Always consult with a healthcare professional for medical advice.