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:

• You are generally active and able to care for yourself, with little or no limitation in daily activities (based on a standard fitness scale scored 0 or 1).
• You have been diagnosed with advanced breast cancer that cannot be surgically removed, or that has spread to other parts of the body, confirmed by a tissue or cell sample.
• You have reached menopause (confirm with trial site for specific requirements).
• You have previously received hormone therapy, with or without a specific type of targeted therapy called CDK4/6 inhibitors, either as earlier preventative treatment or for advanced disease.
• Your cancer has been confirmed by scans to have gotten worse during or after your most recent cancer treatment.
• You have at least one measurable tumour outside the brain that can be tracked on scans, according to standard measurement guidelines.
• Your doctors expect you to live for more than 3 months.
• Your major organs (such as heart, liver, and kidneys) are functioning at an acceptable level (confirm with trial site for specific tests required).
• Enough time has passed since your last cancer treatments before joining — for example, at least 6 weeks since certain chemotherapy drugs, at least 4 weeks since most other cancer treatments or surgeries, and at least 2 weeks since radiotherapy.
• If you are able to become pregnant, you must agree to use effective contraception during the study and for 7 months after treatment ends, have a negative pregnancy blood test within 7 days before joining, and not be breastfeeding.
• You are willing to take part, able to attend the required visits, understand what the study involves, and have signed a consent form.

Who may not be able to join:

• You have brain metastases that are active, causing symptoms, or not yet treated — although people with brain metastases that were fully treated at least 28 days before joining and are no longer causing symptoms may still be considered (confirm with trial site).
• You have a serious heart condition, such as significant heart failure, unstable chest pain, a recent heart attack (within the last 6 months), certain heart rhythm problems, atrial fibrillation, or a recent mini-stroke or stroke.
• You have difficulty swallowing, a bowel blockage, or a digestive condition (such as inflammatory bowel disease, chronic diarrhoea, or previous stomach surgery) that could affect how your body absorbs medication.
• You have uncontrolled fluid build-up in your abdomen, chest, or around your heart, or severe cancer-related swelling in your limbs.
• You are pregnant, breastfeeding, or planning to become pregnant during the study.
• You have significant liver disease, untreated active hepatitis B, or active hepatitis C.
• You have uncontrolled long-term conditions affecting your lungs, liver, kidneys, or heart.
• You have an active autoimmune disease, a weakened immune system, HIV, a history of organ or bone marrow transplant, or currently take steroid or immune-suppressing medications for a long-term condition.
• You have active tuberculosis that requires antibiotic treatment.
• You have been diagnosed with another cancer within the past 5 years — with possible exceptions for fully cured skin cancer or certain cervical conditions, or a secondary cancer that has been fully treated with no recurrence (confirm with trial site).
• You have recently taken certain medications that strongly affect how the body processes drugs (known as CYP3A4 inhibitors within 1 week, or CYP3A4 inducers within 2 weeks before starting the trial).
• You have a history of neurological or psychiatric disorders, or a history of substance abuse or drug addiction.
• You are expected to receive other cancer treatments during the study.
• You have had ongoing side effects from previous cancer treatment that have not resolved (with some exceptions, confirm with trial site).
• You have a known allergy to any of the study drugs or their ingredients.
• You have other serious health problems or test results that the study doctor believes would make participation unsafe or affect the study results.

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