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:

• People who are older than 18 years of age
• People who are well enough to carry out daily activities, ranging from fully active to capable of limited self-care (as assessed by a doctor using a standard scale)
• People who are able to understand and sign a consent form agreeing to take part in the study
• People who are willing and available to follow all study procedures for the full length of the study
• People who have advanced breast cancer (meaning it cannot be removed by surgery or has spread to other parts of the body) that has been confirmed by lab testing to be hormone receptor positive (HR+) and HER2 negative (HER2-)
• People whose cancer is considered sensitive to hormone-based treatments, meaning it did not come back in the first 2 years of hormone therapy after surgery, or did not progress within the first 6 months of hormone therapy used for advanced disease
• People whose cancer has progressed — either seen on scans or assessed by their doctor — after at least 6 months of treatment with a type of drug called a CDK4/6 inhibitor (with or without hormone therapy) for advanced disease, or within 6 months of finishing a CDK4/6 inhibitor given after surgery
• People for whom an additional course of CDK4/6 inhibitor treatment is considered possible and available by their treating doctor
• People who have received zero or one prior course of chemotherapy or a type of targeted drug called an antibody-drug conjugate for their advanced cancer
• People who have had, or are able to have, a specific type of detailed genetic test (called next-generation sequencing) done on a tumour tissue sample collected within 6 months before joining the study and after having received a CDK4/6 inhibitor — with the sample coming from a non-bone site (confirm with trial site for details on acceptable tissue sources and labs)
• People whose cancer is identified as sensitive to a specific CDK4/6 inhibitor drug called palbociclib, based on a particular predictive model called the palbo-VNN model
• People who have cancer that can be measured or tracked on scans or other assessments
• People whose blood counts and organ function meet the following minimum levels: white blood cell count above 3,000 per microlitre, haemoglobin above 8 g/dL, neutrophil count above 1,200 per microlitre, and platelet count above 75,000 per microlitre
• People of reproductive potential who are willing to use effective non-hormonal contraception (such as a copper IUD, barrier methods, or diaphragm with spermicide) for at least one month before starting treatment and for three months after finishing — for female participants; and who agree to use condoms or other effective methods during and for three months after treatment — for male participants (partners of male participants may use hormonal contraception)
• People who have received or are receiving palliative radiotherapy
• People who have cancer that has spread to the brain or the lining around the brain, if their treating doctor determines that immediate specialised brain treatment is not needed and is unlikely to be needed in the first treatment cycle
• People living with HIV who are on effective treatment and have had an undetectable level of virus in their blood within the past 6 months
• People with a long-term hepatitis B infection whose virus levels are undetectable while on suppressive treatment (if treatment is needed)
• People who have had hepatitis C and have been successfully treated and cured, or who are currently being treated for hepatitis C with an undetectable viral load
• People who have had or currently have another type of cancer, if that cancer or its treatment is not expected to interfere with this study's safety or results

Who may not be able to join:

• People whose life expectancy is estimated to be less than 6 months
• People who have a medical or mental health condition that would make it unsafe to take the study drugs or prevent them from participating in study procedures
• People who are currently taking part in another clinical trial involving an investigational drug within 3 weeks of joining this study, if that drug is known to interact with the study medications (confirm with trial site regarding washout requirements)
• People with serious uncontrolled health conditions, such as an active infection, heart failure, unstable chest pain, irregular heartbeat, a lung condition requiring continuous oxygen, severe liver disease, kidney failure requiring dialysis, or a psychiatric condition that would prevent full participation
• People for whom the drugs used in this trial — abemaciclib, palbociclib, ribociclib, or fulvestrant — are not available as a standard treatment option through their treating doctor or health system
• People who are pregnant or currently breastfeeding

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