Phase 3 Breast Cancer Trial, Recruiting

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

Who might be able to join this trial:

• People who are in good general health and able to carry out daily activities with little or no limitation (measured by a standard scale called ECOG, with a score of 0 or 1).
• People whose cancer has one or more specific gene mutations in a gene called PIK3CA, which are known to drive cancer growth.
• Adult women (whether before or after menopause) and adult men. Women who have not yet gone through menopause may be eligible if they are willing to receive a hormone-suppressing injection (called a GnRH agonist) that must have been started at least 4 weeks before joining the trial, and must be continued for the whole study.
• People who have been diagnosed with a type of breast cancer that is hormone receptor positive and HER2 negative (HR+/HER2−), and whose cancer has either spread to other parts of the body or has come back locally in a way that cannot be removed by surgery to cure it. The diagnosis must have been confirmed through a tissue or cell sample.
• People whose cancer can be measured on scans (using a standard method called RECIST v1.1), or who have cancer affecting only the bones that can be assessed even if not measurable in the standard way.
• People whose cancer has been shown on scans to have grown or spread after receiving prior treatment, including: at least one but no more than two rounds of hormone therapy (either before/after surgery or for advanced disease, with the cancer returning during or within 12 months of finishing), and one prior course of a type of drug called a CDK4/6 inhibitor (either combined with hormone therapy for advanced disease, or used after surgery if the cancer came back during or within 12 months of finishing that treatment).

Who may not be able to join:

• People who have previously been treated with certain types of targeted drugs, including: CDK2 or selective CDK4 inhibitors or similar experimental drugs; drugs that block a cell-signalling pathway called PIK3/AKT/mTOR (such as PIK3, AKT, or mTOR inhibitors); immunotherapy; or antibody-drug conjugates.
• People who have Type 1 diabetes, Type 2 diabetes that requires medication to control blood sugar, or blood sugar levels above a certain threshold on fasting blood tests, or a blood marker called HbA1c at or above 7.0%.
• People with significant, uncontrolled heart or blood vessel disease.
• People with factors that increase the risk of a specific type of heart rhythm abnormality (called QTc prolongation or arrhythmia) (confirm with trial site).
• People with active cancer that has spread to the brain or spinal cord and is causing worsening symptoms, or that requires ongoing steroid or anti-seizure medication to manage symptoms.
• People with a past or current history of a lung condition called interstitial lung disease, including cases caused by medication or radiation treatment that required steroid therapy, or any currently active signs of this condition.
• People who have had an allergic reaction to the study drugs being tested (fulvestrant, RLY-2608, or capivasertib) or to closely related drugs or their ingredients.
• People whose cancer is driven by specific other gene changes — activating mutations in AKT, or loss of a gene called PTEN — that activate a cell-signalling pathway downstream of PIK3.

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