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 a woman aged 18 or older
• Your general health and ability to carry out daily activities falls within an acceptable range, as rated by your doctor on a standard scale (ECOG score of 0–2)
• You have been diagnosed with breast cancer that has come back or spread to other parts of the body, including cases where it had already spread when first diagnosed or cannot be removed by surgery
• Your breast cancer has been confirmed by a lab test to be estrogen receptor (ER) positive and/or progesterone receptor (PR) positive, with the ER present in 10% to 50% of tested cells
• Your breast cancer has been confirmed by a lab test to be HER2-negative
• Your doctor has determined that your disease is progressing quickly — for example, it has spread to internal organs and is causing symptoms, is advancing rapidly, or is causing significant symptoms that need urgent treatment
• You have not yet received any cancer treatment (such as chemotherapy or targeted therapy) for the cancer at this returned or spread stage
• You have at least one tumour that can be measured using standard imaging methods
• You are either post-menopausal, or if you are pre- or peri-menopausal, you are willing to receive a specific hormone-suppressing injection (LHRHa) during the study
• Your blood, kidney, and liver test results meet the required levels set by the trial before joining (confirm with trial site)

Who may not be able to join:

• You have already received systemic cancer treatment (such as chemotherapy or targeted therapy) for your cancer at the recurrent or metastatic stage
• You have previously been treated with a type of drug called a CDK4/6 inhibitor before or after surgery (in the neoadjuvant or adjuvant phase)
• You have cancer that has spread to the brain and is causing symptoms
• You have a history of significant heart, liver, lung, kidney, blood, hormonal, or mental health conditions that have caused noticeable symptoms
• You have a serious ongoing illness, such as an active infection, or conditions that would make it difficult to take or absorb tablets by mouth
• You are pregnant or breastfeeding (a pregnancy test is required within 14 days before starting the trial)
• Your overall health is too poor to tolerate chemotherapy treatment
• Your doctor feels, for any reason, that this trial is not appropriate for you

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