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 willing to take part, fully understand what the study involves, and sign a consent form.
• Women aged 18 to 75 at the time of signing the consent form.
• People with a general health and activity level rated as fully active or restricted only in physically strenuous activity (as measured by a standard oncology scale).
• People with a life expectancy of at least 3 months.
• Women with locally advanced or metastatic breast cancer that cannot be treated with surgery or other local treatments, where the cancer has been confirmed by tissue testing to be hormone receptor positive and HER2 negative.
• People who have not previously received systemic (whole-body) treatment for their locally advanced or metastatic breast cancer.
• People who have at least one tumour that can be measured on scans according to standard criteria.
• Women who are postmenopausal, or who are pre- or perimenopausal and are willing to receive a hormone-suppressing injection called goserelin during the study.
• People whose blood test results before the start of the study show their organs are functioning well enough to meet the study's requirements.

Who may not be able to join:

• People who have previously been treated with a CDK4/6 inhibitor (a type of targeted cancer drug).
• People with inflammatory breast cancer.
• People the treating doctor considers unsuitable for hormone-based (endocrine) therapy.
• People who have had another cancer in the 5 years before starting the study treatment.
• People with known cancer spread to the brain or central nervous system.
• People who are taking anti-tumour traditional Chinese medicines at the time of signing the consent form.
• People who have had surgery within 28 days before the start of study treatment and have not yet fully recovered from it.
• People with a history of heart attack, unstable chest pain, serious irregular heartbeat, or heart failure; or whose heart function tests fall outside the required ranges for this study.
• People with a history of stroke or serious blood clot conditions before starting the study treatment.
• People taking certain strong medications that significantly affect how the body processes a group of drugs (called CYP3A4 inhibitors or inducers) at the time of signing the consent form (confirm with trial site).
• People with active hepatitis B at certain viral levels, active hepatitis C, or known HIV infection.
• People who have taken another experimental drug as part of a clinical trial within 30 days before starting this study's treatment.
• People with a history of severe allergic conditions or known allergy to any ingredient in the study drug.
• People with conditions that may affect their ability to take medication or absorb it through the digestive system, as judged by the treating doctor.
• People with an uncontrolled infection within 2 weeks before the start of study treatment, as judged by the treating doctor.
• Women who are pregnant or breastfeeding.
• People with a known history of substance abuse, heavy alcohol use, or illegal drug use, or a diagnosed neurological or psychiatric condition.
• People who, in the opinion of the treating doctor or study sponsor, have other health conditions where the risks of the study treatment outweigh the potential benefits.

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