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:

• People who are able to understand and sign a consent form agreeing to take part in the study
• Adults aged 18 or older (or the minimum age allowed in the country where the trial is taking place)
• People who have been confirmed through lab testing to have a type of breast cancer that is oestrogen receptor positive (ER+) and HER2 negative, where surgery or radiation to cure the disease is not an option
• People who have not yet received any systemic (whole-body) cancer treatment for their breast cancer that has come back or spread to other parts of the body
• People who either were first diagnosed with Stage 4 (advanced/metastatic) breast cancer, or whose cancer came back after completing standard hormone-blocking therapy following early-stage treatment — with at least 12 months having passed since the last dose of a type of hormone therapy called an aromatase inhibitor (AI), and a 2-week break after any tamoxifen use before joining the trial
• People whose general health and ability to carry out daily activities meets a standard rating of 0 or 1 on a scale used by doctors (meaning fully active or restricted in strenuous activity only) (confirm with trial site)
• People whose kidneys, liver, and blood counts are working at an adequate level
• Female participants who could become pregnant must either use highly effective contraception from screening until 4 weeks after stopping the study treatment, and have a negative pregnancy blood test before starting, or must have confirmed evidence that they cannot become pregnant (for example, being post-menopausal or having had both ovaries surgically removed)
• Pre- or peri-menopausal women may be considered if they are willing to receive monthly hormone-suppressing injections (goserelin or leuprorelin) throughout the trial, starting on or before the first dose of the study treatment
• Male participants must either be surgically sterile or use an accepted contraception method throughout the trial and for the washout period afterward, and must not donate or bank sperm during this time
• Male participants may be considered if they are willing to receive monthly hormone-suppressing injections (goserelin or leuprorelin), unless they have a documented history of having had both testicles surgically removed, and must be willing to use two non-hormonal contraception methods throughout the study

Who may not be able to join:

• People for whom a combination of hormone therapy and the drug ribociclib (a CDK4/6 inhibitor) is not considered clinically appropriate by their treating doctor
• People who do not have confirmed advanced disease that cannot be surgically removed, or who have cancer that has spread only to bone in a specific hardened (sclerotic/osteoblastic) form, based on standard imaging (confirm with trial site)
• People whose cancer has spread extensively to internal organs in a way that is causing serious symptoms and poses a risk to life in the near term, or who have cancer spreading through the lymph vessels of the lungs
• People who are still experiencing significant side effects (above a moderate level) from a previous cancer treatment
• People with a currently active infection, including tuberculosis, hepatitis B, or hepatitis C
• People who have tested positive for HIV — although people with HIV whose condition meets specific guidelines set by the FDA and ASCO may still be considered (confirm with trial site)
• People who have clinically significant abnormal heart rhythm or electrical conduction problems — though people with pacemakers or medically managed atrial fibrillation are not automatically excluded (confirm with trial site)
• People who have ongoing low blood pressure that is causing symptoms
• People who are currently pregnant or breastfeeding, or who are unwilling to use the required contraception methods as set out by the trial

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