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:

• You are a woman aged 18 or older who is postmenopausal (either naturally, due to both ovaries being removed, or confirmed by hormone blood tests), or if you are pre/perimenopausal, you must be willing to receive hormone-suppressing injections (LHRH agonists) during the study.
• You have been diagnosed with breast cancer that is hormone receptor (HR) positive and HER2 negative, meaning the cancer is fuelled by hormones but does not have high levels of a certain protein (HER2), confirmed by laboratory testing.
• Your cancer cannot be fully treated by surgery or radiation with the aim of curing it.
• You have either newly diagnosed stage IV breast cancer or cancer that has come back and spread, including to internal organs — even if you are experiencing serious complications from organ involvement such as fluid build-up, breathing difficulties, or rapidly rising bilirubin levels.
• Your general health and ability to carry out daily activities meets a certain minimum standard (ECOG score 0–2 — confirm with trial site).
• Your blood counts are at acceptable levels, meaning your white blood cells, platelets, and haemoglobin (red blood cell levels) meet specific thresholds without recent medical corrections.
• If you are not postmenopausal or surgically sterile, you have a negative pregnancy test within 7 days before starting the trial and agree to use highly effective contraception during the study and for 1 year after your last dose.
• You are willing to take part voluntarily, sign a consent form, follow the study rules, and attend follow-up appointments.

Who may not be able to join:

• You have previously been treated with CDK4/6 inhibitors (a type of targeted cancer drug) and/or capecitabine (a chemotherapy tablet).
• Your cancer came back within 2 years of finishing hormone-based treatment given after your original surgery (adjuvant endocrine therapy).
• Your cancer has only spread to your bones, with no other areas affected.
• You currently have active cancer that has spread to your brain.
• You have HIV, AIDS, active hepatitis B (with certain virus levels in your blood), active hepatitis C, or a combination of hepatitis B and C.
• You have had any of the following serious heart or blood vessel problems in the 6 months before joining: heart attack, severe chest pain (unstable angina), significant heart failure, certain irregular heart rhythms, atrial fibrillation, heart bypass surgery, stroke or mini-stroke (TIA), symptomatic blood clots in the lungs, or new blood clots.
• You had a serious infection requiring intravenous antibiotics, antifungal, or antiviral treatment within 4 weeks before starting, or you have an unexplained fever above 38.5°C at the time of screening.
• You are unable to swallow tablets, have a bowel blockage, or have any other condition that would prevent you from taking or absorbing the study medications properly.
• You have a known allergy or sensitivity to any of the drugs used in this trial or their ingredients.
• You have a history of receiving a transplanted organ or bone marrow/stem cells from another person.
• You have a known history of misusing substances or drugs.
• You are currently pregnant or breastfeeding.
• The trial doctor believes, for any other reason, that the trial would not be appropriate for you.

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