Phase 2 Breast Cancer Trial, Recruiting

Written by an AI model from the 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 between 18 and 75 years old at the time of signing the consent form (women who have not gone through menopause may also be eligible but would need to receive treatment to temporarily stop their ovaries from working)
• Your breast cancer has been confirmed by a tissue sample to be hormone receptor positive (a specific protein called ER is present at 10% or more) and HER2 negative (confirmed by laboratory testing)
• Your breast cancer is either locally advanced (cannot be fully removed by surgery or other local treatment) or has spread to other parts of the body
• You have previously been treated with a type of cancer drug called CDK4/6 inhibitors as part of hormone-based treatment, and your cancer got worse; you have also received no more than two rounds of chemotherapy
• You have at least one tumour that can be measured on a scan before joining the trial
• Your general physical fitness and ability to carry out daily activities falls within an acceptable range on a standard scale (confirm with trial site)
• Any side effects from previous cancer treatments have mostly cleared up before the screening period (minor side effects like hair loss may be acceptable)
• Your blood, liver, kidney, and heart test results meet the required healthy ranges (confirm with trial site for specific values)
• Your expected survival is at least 3 months
• You are willing to take part and sign a written consent form

Who may not be able to join:

• You have ever taken drugs that target a pathway called mTOR or drugs called HDAC inhibitors at any point in the past
• You have received chemotherapy, targeted therapy, immunotherapy, or similar cancer treatments within the last 4 weeks before starting the trial drug (different time limits apply to certain specific drugs — confirm with trial site)
• You have had a major operation or serious injury within 4 weeks before joining, or you are expected to need major surgery
• You have cancer that has spread to the brain or the lining around the brain, unless it has been stable for at least 4 weeks or is causing no symptoms (confirm with trial site)
• You have other serious health conditions that your doctor believes could put you at risk or stop you from completing the trial (for example, severe high blood pressure, thyroid problems, high cholesterol, or active infection)
• You have diabetes that is not well controlled (as judged by the doctor)
• You have significant digestive or gut problems that could affect how you swallow or absorb the trial medicine (for example, difficulty swallowing, ongoing severe diarrhoea, or bowel blockage)
• You have a serious heart condition, such as significant heart failure, unstable chest pain, a heart attack in the last 6 months, or a serious irregular heartbeat
• You have active hepatitis B, active hepatitis C, or are known to be HIV positive
• You are pregnant, breastfeeding, have a positive pregnancy test at the start of the trial, or are of childbearing age and are unwilling to use effective contraception throughout the trial and for 90 days after the last dose
• You have a confirmed history of a significant neurological or mental health condition, such as epilepsy or dementia
• Your doctor believes, for any reason, that joining this trial would not be appropriate for you

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