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A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

Trial comparing Giredestrant and Fulvestrant for advanced breast cancer.

Recruiting
18 years and older
All
Phase 3

This study is about comparing two treatments, **giredestrant** and **fulvestrant**, for a type of breast cancer called ER-positive, HER2-negative advanced breast cancer. ER-positive means the cancer grows in response to estrogen, and HER2-negative means it lacks a protein that can promote cancer growth. Participants should have cancer that has stopped responding to previous hormone treatments. The study will test these drugs with other medicines called **CDK4/6 inhibitors** (like palbociclib, ribociclib, or abemaciclib). CDK4/6 inhibitors help stop cancer cells from growing. This is a Phase III study, meaning the drugs have already been tested for safety and effectiveness in earlier studies.

  • The study is "open-label", so both doctors and patients know which treatment is given.
  • Participants must not have received certain other cancer treatments before.
  • Participants will need to commit to ongoing treatment, possibly including injections, for the study's duration.

Consider joining if you meet the criteria and are open to the treatment plan. This study aims to find safer and more effective treatments for advanced breast cancer.

Study details
    Estrogen Receptor-Positive
    HER2-Negative Advanced Breast Cancer

NCT06065748

Hoffmann-La Roche

16 March 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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