NCT04191499

Who might be able to join this trial:

• You have been diagnosed with breast cancer that is hormone receptor-positive (HR+) and HER2-negative
• Your cancer has spread to other parts of the body or is advanced in a way that cannot be cured with current treatments
• Your cancer got worse while you were taking hormone-blocking therapy (such as an aromatase inhibitor or tamoxifen), or it came back within 12 months of finishing that therapy
• If you have not yet gone through menopause, you have been receiving a specific hormone-suppressing injection (LHRH agonist) for at least 2 weeks before starting the trial
• Your tumor has tested positive for a specific gene change (PIK3CA mutation) using an approved test
• You are willing to provide a tumor tissue sample (either a recent biopsy or a stored sample)
• Your cancer can be measured on scans according to standard criteria (RECIST v1.1); cancer that has only spread to bones without a measurable soft-tissue component does not qualify (confirm with trial site)
• You are able to carry out normal daily activities with little or no limitation (confirm with trial site)
• You are expected to live for more than 6 months
• Your blood counts and organ function (such as liver and kidneys) are at acceptable levels within 14 days before starting treatment

Who may not be able to join:

• You have a specific rare type of breast cancer called metaplastic breast cancer
• You have ever had cancer spread to the membranes surrounding your brain or spinal cord
• You have previously received any systemic (whole-body) treatment for breast cancer that has spread
• You have previously been treated with fulvestrant or a similar drug, unless it was given before surgery for no longer than 6 months
• You have previously been treated with drugs that target a specific cell-signalling pathway called PI3K, AKT, or mTOR
• You have Type 1 diabetes at any point in your history, or you currently need ongoing medication to manage Type 2 diabetes
• You have brain metastases (cancer spread to the brain) that are known but have not been treated, or are currently active; people with previously treated brain metastases may still be eligible (confirm with trial site)
• You have an active eye infection or inflammation, or you are expected to need eye surgery during the trial
• You have active lung disease causing symptoms, or you need to use supplemental oxygen every day
• You have a history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), or currently have active bowel inflammation
• You have received any cancer treatment within 2 weeks before joining the trial
• You have taken part in another clinical trial involving an experimental drug within 4 weeks before joining
• You have previously had radiation therapy covering 25% or more of your bone marrow, or you have had a stem cell or bone marrow transplant
• You are currently taking long-term steroid medications or drugs that suppress the immune system
• You are pregnant, breastfeeding, or planning to become pregnant during the trial or within 2 weeks after your last dose of study treatment
• You have had a major operation or a serious physical injury within 28 days before starting the trial

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