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A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)

Exploring new breast cancer treatments with Tersolisib and other therapies.

Recruiting
18 years and older
All
Phase 3

Study Overview: This study looks at adding a new drug called Tersolisib to other cancer treatments for people with advanced breast cancer that has a specific genetic change called PIK3CA. The goal is to see if Tersolisib helps treat the cancer without causing bad side effects.

  • Duration: The study continues as long as the drug helps and doesn't cause intolerable side effects.
  • Visits: Participants may need to visit the study site regularly for monitoring.
  • Eligibility: Participants must agree to use birth control and meet specific health criteria, such as having a PIK3CA mutation.

Key Terms: Hormone receptor-positive (HR+) means the cancer grows with hormones like estrogen. HER2-negative means the cancer doesn't grow from a protein called HER2. GnRH agonist is a drug that affects hormone levels. ASCO/CAP Guidelines are rules used to check cancer features.

Considerations: Participants cannot have certain health conditions like diabetes or active infections. It's important to be willing to follow the study's rules, including using birth control.

Study details
    Breast Neoplasms
    Neoplasm Metastasis

NCT07174336

Eli Lilly and Company

10 October 2026

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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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