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 18 to 74 years, whether they have gone through menopause, are approaching menopause, or are still having periods (women still having periods must be willing to receive a hormone-suppressing treatment called an LHRH agonist during the study)
• People whose breast cancer has been confirmed by tissue testing to be a type driven by the hormone estrogen (more than 10% ER-positive) and is HER2-negative
• People with at least one area of cancer that can be measured on scans, and whose cancer falls within certain size and spread categories (confirm specific staging with trial site)
• People who have not previously received any cancer treatment for breast cancer, including chemotherapy, hormone therapy, or targeted therapy
• People who are able to swallow tablets or capsules
• People whose heart is pumping well enough, with a heart pumping function of at least 50% on testing
• People whose blood counts, liver, and kidney function meet specific healthy ranges on recent tests (within one week before joining)
• People whose heart electrical activity (measured by an ECG) shows a certain reading within a safe range
• People who are willing and able to have tissue biopsies as required by the study
• Women who could become pregnant must have a negative pregnancy test before starting and agree to use reliable contraception throughout the study; women who are post-menopausal are not required to do this
• People who are willing to take part voluntarily, sign a consent form, and attend all required follow-up visits

Who may not be able to join:

• Women who are pregnant, breastfeeding, or have a positive pregnancy test at the start of the study, or women who could become pregnant but are unwilling to use effective contraception
• People who have cancer in both breasts, or who have a type called inflammatory breast cancer
• People whose breast cancer has already spread to other parts of the body (Stage IV) at the time of diagnosis
• People with a history of heart failure, unstable chest pain (angina), serious heart rhythm problems, or a heart attack
• People with active lung conditions, such as lung inflammation, pneumonia, or lung scarring
• People with serious liver disease, such as severe or sudden-onset hepatitis or problems with blood clotting related to liver function
• People with a certain hepatitis B infection marker in their blood, unless the level of the virus in their blood is below a specific threshold (confirm details with trial site)
• People with any other ongoing illness or condition that could interfere with safe participation in the study, such as an active or uncontrolled infection
• People who have, or have had, another type of invasive cancer that could affect the study results or their ability to participate
• People who have previously received chemotherapy, hormone therapy, or biological therapy for breast cancer (a diagnostic biopsy is not considered treatment)
• People who have had major surgery within four weeks before joining, or who have unresolved serious medical issues
• People whose tumour cannot be measured during the treatment phase of the study
• People who, in the opinion of the study doctor, are not suitable for any other reason

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