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 aged 19 years or older at the time of signing the consent form
• People diagnosed with hormone receptor-positive, HER2-negative breast cancer that has spread to other parts of the body or cannot be removed with surgery
• People whose cancer has continued to grow after receiving hormone therapy and a CDK4/6 inhibitor treatment
• People whose blood counts and organ function (liver, kidneys, and bone marrow) fall within acceptable ranges when tested within 28 days before starting the study
• People with a general health and activity level rated as fully active or restricted only in physically strenuous activity (ECOG score of 0 or 1)
• People with a life expectancy of at least 16 weeks
• People who have at least one area of cancer that can be measured or assessed by CT or MRI scan at the start of the study and monitored over time
• Women who are past menopause, or who have had surgical sterilisation, or whose menopause was brought on by chemotherapy or radiation — or women who are pre- or peri-menopausal and are willing to receive monthly hormone-suppressing injections (goserelin or leuprorelin) starting at least 3 weeks before the first treatment
• Women who could potentially become pregnant must have a negative pregnancy test within 28 days before starting treatment and again on the first day of treatment
• Male participants must use a condom during treatment and for 3 months after the last dose when having sexual intercourse with a pregnant woman or a woman who could become pregnant; female partners who could become pregnant should also use a highly effective form of contraception
• For Cohort A only: People with a known inherited (germline) or tumour-based (somatic) mutation in the BRCA1 or BRCA2 gene
• For Cohort B only: People with a known tumour-based mutation in BRCA1, BRCA2, or certain other DNA repair genes (such as ATM, ATR, BRIP1, PALB2, CHEK1, CHEK2, FANC family, RAD51 family, and similar genes) — eligibility for other DNA repair gene changes can be discussed with the principal investigator

Who may not be able to join:

• People whose doctor judges that a health condition or illness makes it inadvisable for them to take part
• People who have had another cancer in the past, unless it was fully treated with no signs of return for 5 or more years — certain exceptions apply for some low-risk or non-invasive cancers (confirm with trial site)
• People with certain uncontrolled heart conditions shown on a resting ECG, or those born with a condition called long QT syndrome
• People still experiencing significant side effects (above a moderate level) from previous cancer treatments, apart from hair loss
• People with a blood or bone marrow disorder called myelodysplastic syndrome or acute myeloid leukaemia, or signs suggesting these conditions
• People with active, uncontrolled cancer that has spread to the brain; people with spinal cord compression unless it has been definitively treated and the condition has been stable for at least 28 days
• People considered to be at serious medical risk due to uncontrolled medical conditions, serious infections, or certain conditions such as a recent heart attack (within 3 months), uncontrolled seizures, or a psychiatric disorder that prevents giving informed consent
• People who are unable to swallow tablets or capsules, or who have digestive conditions that would prevent the medication from being properly absorbed
• People with a weakened immune system, including those known to be HIV-positive
• People with active hepatitis B or hepatitis C infection (certain past or resolved cases may still be eligible — confirm with trial site)
• People weighing 30 kg or less
• People with a history of serious bleeding disorders, or those on long-term blood-thinning medication — although people on low-dose blood thinners with a normal clotting level may still be eligible (confirm with trial site)
• People who have previously received fulvestrant, olaparib, or other drugs that directly target DNA damage repair pathways
• People who have received chemotherapy or radiotherapy (other than for pain relief) within 3 weeks before starting the study
• People currently taking certain medications that strongly or moderately affect how the body processes a liver enzyme called CYP3A, including some antifungals, antibiotics, and HIV medications — a washout period of 2 weeks is required before starting the study (confirm with trial site)
• People currently taking certain medications that strongly or moderately reduce the effectiveness of CYP3A-processed drugs, including some anti-seizure medications, certain antibiotics, and St John's Wort — washout periods of 3 to 5 weeks are required depending on the specific drug (confirm with trial site)
• People who have had major surgery within 2 weeks before starting the study, or who have not yet fully recovered from major surgery
• People who have previously had a bone marrow transplant or a double umbilical cord blood transplant
• People who have taken part in another clinical trial involving an investigational medicine within the past 4 weeks, or within 5 half-lives of that medicine — whichever is the longer period
• People with a known allergy to fulvestrant, olaparib, or any of the ingredients in the study medicines
• People who have been involved in planning or running this study
• People who the investigator believes are unlikely to follow the study procedures and requirements
• People who have previously been enrolled in this study
• Women who are currently breastfeeding

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