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A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy

What is this study?

This study is testing a new pill called giredestrant to see if it works better than the standard treatment, fulvestrant. Both drugs are being tested in combination with common cancer-growth blockers to help treat advanced breast cancer that has stopped responding to earlier hormone therapies.

Who can participate?

This trial is for adults with advanced breast cancer that is estrogen-receptor positive (ER+) and HER2-negative. You must have had your cancer return after previous hormone therapy and have not yet received chemotherapy or immunotherapy for this advanced stage of the disease.

What will happen?

You will be randomly assigned to take either the new drug or the standard treatment, combined with a daily cancer-growth blocker. You will also have a simple blood test to look for specific genetic changes in your cancer cells to help doctors understand how your tumor responds.

Where and when?

The study is currently recruiting patients at specific centers in Daphne, Alabama, and Glendale and Auburn, California. Please talk to your oncologist to see if a location near you is available.

Key Points
  • 1Tests a new oral medication against the current standard treatment.
  • 2Specifically for patients whose breast cancer no longer responds to initial hormone therapy.
  • 3Requires a blood test to check for specific genetic traits in your cancer.

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Conditions Studied
This study is investigating treatments for the following conditions
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer

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