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:

• Adults of any gender, including women who are pre-menopausal, peri-menopausal, or post-menopausal
• People with a confirmed diagnosis of hormone receptor-positive, HER2-negative breast cancer (confirmed through a tissue or cell sample)
• People whose breast cancer is either advanced and cannot be cured with local treatment, or has spread to other parts of the body
• People who are generally well enough to carry out daily activities, with no significant decline in health over the past 2 weeks (based on a standard medical fitness scale)
• People who are able to provide a stored tumour tissue sample
• People who have a confirmed inherited gene mutation in BRCA1, BRCA2, or PALB2 (genes linked to increased cancer risk)
• People whose kidneys, liver, and bone marrow are functioning well enough to participate

Who may not be able to join:

• People with a history of, or signs suggesting, certain blood or bone marrow cancers (MDS or AML)
• People with any known tendency toward excessive bleeding
• People who have had persistently very low blood cell counts (a condition called severe cytopenia)
• People with serious, uncontrolled illness or an active infection that is not under control
• People who have ongoing severe nausea or vomiting, a chronic digestive condition, difficulty swallowing tablets, or who have had significant bowel surgery in the past
• People with a history of a second separate primary cancer (confirm with trial site)
• People still experiencing significant side effects (grade 2 or higher) from previous cancer treatment, not including hair loss
• People with cancer that has spread to the spine, brain, the lining of the brain, or the fluid around the brain and spinal cord
• People with active, uncontrolled hepatitis B or hepatitis C infection
• People with active, uncontrolled HIV infection
• People with active tuberculosis
• People with certain heart conditions, including a history of irregular heartbeat or cardiovascular disease (confirm with trial site for full details)
• People currently using hormone therapy (such as hormonal contraception or hormone replacement therapy) that is not applied to the skin, for reasons unrelated to cancer
• People who have had major surgery or a serious injury within 4 weeks before the first dose, or who are expected to need major surgery during the trial
• People who have received radiation therapy to a limited area within 2 weeks, or to a large area or more than 30% of the bone marrow within 4 weeks, before the first dose
• People who have previously received systemic anti-cancer treatment for advanced or returning breast cancer, except for hormone therapy taken up to 28 days before being assigned to a treatment group
• People who have received a blood transfusion or growth factor treatment within the 28 days before joining
• People currently receiving any other systemic cancer treatment
• People currently taking, or who have taken within the past 21 days (or within 5 half-lives), certain medications or herbal supplements that affect how the body processes drugs — including strong or moderate CYP3A4 inducers or inhibitors, certain other enzyme-related medications, or blood thinners such as warfarin and phenytoin (confirm with trial site for the full medication list)
• People taking medications known to affect heart rhythm in a specific way (QT prolongation with a risk of a dangerous rhythm called TdP)
• People using atropine as a systemic (whole-body) medication
• People whose cancer progressed within 84 days of finishing chemotherapy given before or after surgery for early breast cancer
• People whose cancer progressed within 1 year of finishing treatment with a PARP inhibitor or platinum-based chemotherapy for early breast cancer
• People whose cancer progressed within 1 year of finishing CDK4/6 inhibitor treatment given after surgery for early breast cancer
• People whose cancer progressed within 1 year of finishing an oral SERD medication, including camizestrant, for early breast cancer

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