Phase 2 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:

• People who are willing to take part voluntarily and are able to follow the study schedule and visit requirements, and who have signed a consent form
• People aged 18 or older, of any gender
• People whose general physical functioning is rated as 0 or 1 on a standard health performance scale (confirm with trial site)
• People whose life expectancy is at least 12 weeks, as assessed by their doctor
• People with locally returning or spread (metastatic) advanced breast cancer that is ER-positive and HER2-negative, confirmed by a tissue or cell sample test
• People whose cancer has not responded to at least one previous hormone-based (endocrine) therapy
• People who have at least one tumour that can be measured on scans, according to a standard measurement system called RECIST v1.1
• People whose major organ functions (such as liver, kidneys, and blood) are within acceptable levels as required by the study
• People who are able and willing to use highly effective contraception throughout the treatment period and for 180 days after the last dose — this applies to women who could become pregnant and to men
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before the first dose, and must not be breastfeeding at the time of joining

Who may not be able to join:

• People who have received a live or weakened-live vaccine within 4 weeks before starting the study drug
• People who have had major surgery on an organ within 4 weeks before starting the study drug
• People who need long-term or high-dose use of non-steroidal anti-inflammatory drugs (such as ibuprofen or similar medicines)
• People who still have side effects from a previous cancer treatment that have not improved to a mild level (grade 1 or lower)
• People with a known or suspected serious allergy to the study drug or any of its ingredients
• People who have had another active cancer within the 3 years before starting the study drug
• People who have cancer that has spread to the brain, or who have cancer affecting the membranes surrounding the brain or spinal cord
• People who have active tuberculosis, inflammation of the lungs from radiation, drug-related lung inflammation, lung scarring (pulmonary fibrosis), or other conditions that seriously affect lung function
• People who are unable to swallow tablets, or who have digestive system problems that their doctor thinks could affect how the drug is absorbed
• People who have had a serious heart or stroke-related condition within the 6 months before starting the study drug
• People with high blood pressure that remains poorly controlled despite taking multiple blood pressure medications

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