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Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer

Comparing two treatments for advanced breast cancer in a clinical trial.

Recruiting
18 years and older
All
Phase 3

This study tests two different treatments for a specific type of breast cancer that has spread or can't be removed by surgery. The cancer has a PIK3CA mutation, which means there's a change in a gene that can affect cell growth. Patients have previously used a CDK4/6 inhibitor, a type of drug that helps stop cancer cells from dividing.

In this study, patients will be given either RLY-2608 (also called zovegalisib) with fulvestrant, or capivasertib with fulvestrant. Fulvestrant is a drug that blocks estrogen, which can help stop cancer growth.

  • The study is for adults, both women and men, who meet certain health criteria.
  • Participants must have cancer that has returned or worsened after previous treatments.
  • People with certain health issues, like specific heart or lung diseases, or uncontrolled diabetes, cannot join.

It's important to consider the time commitment and possible side effects before joining. Participants will be closely monitored to ensure their safety throughout the study.

Study details
    PIK3CA Mutation
    HER2- Negative Breast Cancer
    Hormone Receptor Positive Tumor
    Breast Cancer
    Metastatic Breast Cancer
    Advanced Breast Cancer

NCT06982521

Relay Therapeutics, Inc.

11 October 2026

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FAQs

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.

How safe are clinical trials?

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