Phase 2 Ovarian 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 18 or older
• People who are willing and able to follow the study schedule, including visits, treatments, tests, and other procedures for the full duration of the trial
• People who are enrolled in a social security system or equivalent health coverage scheme
• Women who are premenopausal, confirmed either by having had regular periods in the last 6 months without hormonal treatment or contraception, or by hormone blood test results falling within the premenopausal range (confirm with trial site)
• People with a confirmed breast cancer diagnosis from a tissue sample, where the cancer is oestrogen receptor (ER)-positive (≥10% staining), HER2-negative, and has a specific cell growth marker (Ki67) between 10% and 30%, measured on untreated tumour tissue
• People with early-stage breast cancer (Stage I or II) that a surgeon considers suitable for upfront breast surgery — tumours that appear in multiple spots in the breast may still be eligible if they fall within Stage I or II
• People who have a pre-treatment tissue biopsy sample available for testing
• People with a general health status rated 0 or 1 on a standard medical fitness scale (meaning fully active or able to carry out light activity), assessed within 14 days before joining the study
• Women who could potentially become pregnant and have a negative blood pregnancy test taken within 72 hours before the first dose of study medication
• People whose blood test results show that their bone marrow, kidneys, liver, and electrolyte levels are within acceptable ranges as defined by the study (tested within 7 days of joining)
• Women who could potentially become pregnant and agree to use specific non-hormonal contraception methods — either complete abstinence in line with their usual lifestyle, or a non-hormonal intrauterine device — during treatment and for at least 120 days after the last dose

Who may not be able to join:

• People who are not considered suitable for upfront breast surgery, or who would normally be recommended chemotherapy before surgery
• People who have already received chemotherapy, targeted therapy, immunotherapy, or radiotherapy for their current breast cancer before joining the study
• People who have received LHRH-agonist treatment (a type of hormone-suppressing injection) in the 6 months before signing the consent form
• People currently receiving treatment for any other cancer
• People who have experienced any of the following in the 6 months before joining: heart attack, severe or unstable chest pain, significant heart rhythm problems, a prolonged electrical interval in the heart (QTcF >480ms), uncontrolled atrial fibrillation, heart bypass surgery, moderate-to-severe heart failure, stroke or mini-stroke, significant liver disease (Child-Pugh Class B or C), a severe allergic reaction to the study drug or similar medicines, or a blood clotting disorder including deep vein thrombosis or pulmonary embolism (some exceptions may apply — confirm with trial site)
• People receiving blood-thinning medication (such as warfarin or heparin) for a clotting event that occurred within the past 6 months, unless the clotting event was more than 6 months ago and the medication dose has been stable for at least 28 days (confirm with trial site)
• People who have difficulty swallowing or absorbing oral medications, including those with severe nausea or vomiting, bowel blockage or motility problems, malabsorption conditions, or a history of gastric bypass surgery
• People who are unable or unwilling to avoid certain medications, supplements (such as St. John's Wort), or foods (such as grapefruit, pomelos, star fruit, and Seville oranges) that can interfere with how the study drug is processed by the body — unless these can be stopped for at least 14 days or five half-lives (whichever is longer) before and during the study
• People who are pregnant, breastfeeding, or planning to become pregnant within the study period and up to 120 days after the last dose
• People with any serious ongoing medical or psychiatric condition, or significant abnormal test results, that the investigator believes could increase risk or interfere with the study
• People who are under legal custody, protective supervision, or guardianship
• People whose personal, family, social, or geographical circumstances would make it difficult to follow the study requirements
• People who are unwilling or unable to follow the study protocol, as assessed by the investigator

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