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:

• Women aged 19 years or older
• People with breast cancer that has been confirmed by a tissue test (biopsy) and cannot be removed by surgery, has spread locally, or has spread to other parts of the body — and where the cancer is hormone receptor positive and HER2 negative
• People who have not previously received hormone therapy or chemotherapy for advanced or metastatic breast cancer
• People who previously received a type of hormone therapy called an aromatase inhibitor (AI) after surgery, as long as it was finished more than 12 months before joining the trial; or people who previously received tamoxifen after surgery, even if it was finished less than 12 months ago
• People with a general health and activity level that falls within an acceptable range as assessed by their doctor (confirm with trial site)
• People who have at least one area of cancer that can be measured or tracked on scans, according to standard criteria
• People whose blood test results show the liver, kidneys, bone marrow, and blood clotting are working within acceptable levels (confirm with trial site for specific values)
• People of childbearing potential who are able to use appropriate contraception during the trial and for at least 6 months after finishing treatment
• People who understand what the trial involves and are willing to follow the trial process

Who may not be able to join:

• People who have previously been treated with a type of drug called a CDK4/6 inhibitor, or any other systemic treatment for advanced or metastatic breast cancer
• People who have previously received a drug called fulvestrant, or any experimental treatment that targets the oestrogen receptor (including drugs known as SERDs)
• People whose cancer came back while they were taking an aromatase inhibitor as hormone therapy after surgery
• People who have cancer that has spread to the brain or spinal cord and is causing symptoms, or has not yet been treated
• People with a history of serious heart conditions, including a heart attack, unstable chest pain (angina), or uncontrolled irregular heartbeat within the past 6 months, or a history of heart failure
• People whose cancer is causing a serious and urgent crisis in their internal organs that requires very rapid treatment
• People who have had another type of cancer in the past, with the exception of certain skin cancers, early-stage cervical changes, or well-differentiated thyroid cancer
• People who are unable to have regular blood samples taken throughout the trial
• People with active hepatitis B or hepatitis C infection, HIV, or a condition that weakens the immune system (note: people with controlled, inactive hepatitis B or fully cleared hepatitis C may still be eligible — confirm with trial site)
• Women who are pregnant or breastfeeding
• People considered unsuitable for the trial by the treating doctor, for any reason

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