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A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

Testing Inavolisib with treatments for certain advanced breast cancer types.

Recruiting
18 years and older
All
Phase 3

This study looks at the effectiveness and safety of adding a new drug, inavolisib, to a treatment for advanced breast cancer. It will be combined with a CDK4/6 inhibitor (a type of medicine that stops cancer cells from growing) and letrozole (a medicine that lowers estrogen levels) and compared to a placebo (a fake treatment). Participants need to have a specific kind of breast cancer called PIK3CA-mutated, hormone receptor-positive, HER2-negative advanced breast cancer.

**Key Points:**

  • The study requires participants to have regular visits to check progress and side effects.
  • People with certain health conditions, like diabetes or specific types of breast cancer, cannot join.
  • Participants must be willing to provide tissue samples and have proper organ function.

Participants must not be pregnant or planning to get pregnant, and should not have received certain previous cancer treatments. If you meet the criteria and are interested, this study could help find better ways to treat advanced breast cancer.

Study details
    Breast Cancer

NCT06790693

Hoffmann-La Roche

7 March 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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