Phase 3 Breast Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have been confirmed (through a biopsy or cell sample) to have breast cancer that is hormone receptor-positive (HR+), HER2-negative, and has either spread to other parts of the body or cannot be surgically removed.
• You are an adult woman (before or after menopause) or an adult man. Women who have not yet gone through menopause may join if they are willing to take a hormone-suppressing injection (LHRH agonist) before and throughout the trial.
• If you are a woman who could become pregnant, you must have a negative pregnancy test and be willing to use effective birth control from the start of the trial until 2 years after your last dose.
• Your cancer got worse either during or within 12 months of finishing hormone therapy given before or after surgery, or it got worse more than 12 months after finishing that hormone therapy.
• You are able to provide a tissue sample (from a previous biopsy or a new one) or a blood sample so researchers can check for a specific gene change (PIK3CA mutation).
• Any previous treatments you received before the cancer spread must meet specific rules about the type and timing of those treatments (confirm with trial site for your specific situation).
• Your cancer can be measured on a scan using standard guidelines. If you only have bone involvement, it must show certain types of bone changes with at least one measurable area of soft tissue.
• Your general health and ability to carry out daily activities is rated as good to moderate on a standard medical scale (ECOG score of 0, 1, or 2).
• Doctors expect you to live for more than 6 months.
• Your blood tests show that your bone marrow, liver, kidneys, and blood clotting are working well enough.

Who may not be able to join:

• You currently have another active cancer, other than certain treated skin cancers. (Previous cancers that have been fully treated and show no signs of returning may be acceptable — confirm with trial site.)
• You have previously been treated with certain targeted therapies, including PI3K inhibitors, AKT inhibitors, mTOR inhibitors, or certain oestrogen-blocking drugs (SERDs), other than fulvestrant used before surgery or shortly after.
• You have already received any systemic (whole-body) cancer treatment for breast cancer that has spread or cannot be removed.
• You have Type 1 diabetes, or Type 2 diabetes that is not well controlled and requires daily insulin.
• You have cancer that has spread to your brain or the lining around your brain, and it has not been treated or is currently active.
• You have a history of serious heart or blood vessel problems.
• You have a known, significant eye condition (confirm with trial site for details).
• You have previously experienced serious lung inflammation (pneumonitis) or liver inflammation (hepatitis) caused by a medication.

Important: Always verify eligibility with the trial site directly before applying.