Phase 1 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 were assigned female at birth, are 18 years of age or older, and are able to give informed consent
• People who have been diagnosed with breast cancer that has spread to other parts of the body or has grown into nearby tissues, confirmed by a tissue sample (biopsy)
• People whose menopausal status is confirmed — either through surgery, natural menopause, or medication that stops the ovaries from producing hormones (called a GnRH agonist)
• People who have previously received at least one hormone-based therapy for advanced breast cancer, at least one CDK4/6 inhibitor (a type of targeted cancer drug, given at any stage), and no more than two chemotherapy regimens for advanced disease
• People whose cancer has been shown on scans to have continued growing on their most recent treatment
• People whose cancer can be measured on scans according to standard criteria (called RECIST v1.1)
• People who are willing to have tissue samples taken at the start of the trial and during treatment, where this is safe and possible
• People whose cancer has been confirmed as oestrogen receptor (ER) positive and HER2 negative within the past two years
• People who are in good general health (as measured by a standard scale called ECOG, score 0 or 1) and are expected to live for at least three months
• People whose organs (such as kidneys and liver) are functioning well enough, and who have recovered from most side effects of previous treatments
• People who are able to swallow tablets or capsules and follow the study requirements
• People who, if taking bone-strengthening medications (bisphosphonates or denosumab), have been on a stable dose for at least 30 days

Who may not be able to join:

• People who have inflammatory breast cancer or cancer that has spread to the brain
• People who have had a significant bleeding episode recently, or who have a bleeding disorder that is not under control
• People who are currently taking corticosteroids (such as prednisone) at a dose above 10 mg per day on an ongoing basis
• People who have received cancer treatment or an experimental therapy within the past 14 days (or 28 days for a drug called fulvestrant)
• People who have pressure on the spinal cord from the cancer that has not been treated or is not stable
• People who have had a serious heart or cardiovascular condition in the past six months, or who have an ongoing heart condition that is not well controlled
• People who have an active infection that is not under control (note: well-controlled HIV or previously treated hepatitis C may be considered — confirm with trial site)
• People who have kidney, pancreatic, or liver disease that is not well controlled (certain stable conditions may be allowed — confirm with trial site)
• People who have had another cancer requiring treatment within the past two years (some low-risk cancers that were fully treated may be considered — confirm with trial site)
• People who have had major surgery within the past 28 days
• People who have any other condition that could affect safety or the ability to follow the study requirements
• People who are pregnant or breastfeeding

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