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 have chosen to take part voluntarily and have signed a consent form
• Women aged 18 or older
• People who are able to provide a blood sample for testing of a gene mutation called ESR1 and other markers (in the second phase of the study, only people with a confirmed ESR1 mutation will be enrolled)
• People with a diagnosis of locally advanced or metastatic breast cancer that has been confirmed by laboratory testing of tissue or cells, where the cancer is hormone receptor-positive (ER-positive) and HER2-negative, as defined by specific laboratory staining results
• People who are confirmed to be in menopause — not due to ovarian suppression medication — meeting one of these conditions: previous surgical removal of both ovaries; aged 60 or older; or aged under 60 with specific hormone level results and menstrual history meeting defined criteria (confirm with trial site)
• Women who are pre-menopausal or approaching menopause who agree to receive and continue ovarian suppression treatment (LHRH agonist injections) throughout the study, starting at least 14 days before the first dose
• People whose prior treatment history meets all of the following: disease has progressed on or they could not tolerate standard treatment; previous hormone therapy for at least 2 years before recurrence, or at least one course of hormone therapy for advanced disease with progression after at least 6 months; no more than 2 prior chemotherapy courses for advanced disease; if previously treated with fulvestrant, at least 6 weeks must have passed since the last dose; if previously treated with tamoxifen, at least 6 weeks must have passed since the last dose; no more than one prior course of CDK4/6 inhibitor treatment
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or restricted in strenuous activity only)
• People with at least one measurable area of cancer according to standard imaging criteria (previously treated lesions are only counted if progression has been confirmed)
• People with an expected survival of at least 3 months
• People whose blood test results show that the kidneys, liver, bone marrow, and heart are functioning within defined acceptable ranges at the time of screening, without having received blood transfusions or certain blood-boosting treatments in the 7 days before testing
• Women of childbearing potential who have a negative pregnancy test within 7 days before the first dose, are not breastfeeding, and agree to use effective contraception from the time of signing the consent form until 6 months after the last dose

Who may not be able to join:

• People with cancer that has spread to the lining of the brain or spinal cord, or with unstable or symptomatic spread to the brain or spinal cord
• People with ongoing gut or digestive conditions that could affect absorption of oral medication, including inability to swallow tablets, need for intravenous feeding, previous stomach surgery, Crohn's disease, ulcerative colitis, active peptic ulcer disease treated within the past 6 months, malabsorption conditions, or uncontrolled nausea, vomiting, or diarrhoea
• People with cancer spread to internal organs causing symptoms, or with significant unstable fluid build-up around the lungs, abdomen, or heart, or cancer spreading through the lung's lymph vessels — unless the fluid has been stable for at least 14 days after drainage or treatment; or people the doctor considers unsuitable for hormone therapy
• People who have not completed the required waiting periods after previous treatments, including: other experimental drugs within 4 weeks; CDK4/6 or mTOR inhibitors within 2 weeks, or other targeted therapies, chemotherapy, or immunotherapy within 4 weeks; radiotherapy, hormone drugs, or certain herbal anti-cancer medicines within 2 weeks; certain chemotherapy agents (mitomycin or nitrosoureas) within 6 weeks; specific drugs known to interact with how this study drug is processed by the body within 2 weeks or 5 half-lives; stomach acid-reducing medications within 2 weeks or 5 half-lives; certain other interacting medications within 2 weeks or 5 half-lives (confirm specific drug lists with trial site)
• People still experiencing side effects from previous cancer treatment rated above a mild level (except hair loss, or mild-to-moderate chemotherapy-related nerve tingling or numbness)
• People who have had major surgery (other than a biopsy) within 4 weeks before the first dose, or whose surgical wound has not fully healed
• People with another active cancer diagnosed within the past 5 years, except for certain skin cancers, cervical changes, a specific type of thyroid cancer, or non-invasive breast changes that have been fully treated
• People with a history of interstitial lung disease, drug-related lung inflammation, or signs of active lung inflammation on a chest scan within 4 weeks before the first dose
• People with poorly controlled high blood pressure despite medication (blood pressure above defined thresholds)
• People with active hepatitis B or hepatitis C infection meeting defined levels of virus in the blood; known HIV infection or AIDS; active tuberculosis; or active syphilis
• People who have had a serious infection requiring antibiotic treatment through a drip within 14 days before dosing, or an active infection requiring systemic treatment
• People who have had a blood clot in an artery or vein within the past 6 months, including stroke, mini-stroke, deep vein thrombosis, or pulmonary embolism
• People with a history of significant heart problems, including: slow heart rate below a defined threshold; angina or coronary artery disease within the past year; moderate-to-severe heart failure, heart muscle disease, or heart-related chest pain requiring ongoing medication; heart attack within the past 6 months; irregular heart rhythms of certain types within the past year; risk factors for dangerous heart rhythms including certain inherited conditions or relevant family history; poorly controlled atrial fibrillation; heart bypass surgery within 6 months; stroke symptoms including mini-strokes; a specific heart electrical reading (QTcF) above 470 ms; or other significant abnormalities on a heart tracing as judged by the doctor
• People with a known history of severe allergic reactions to this study drug or its ingredients
• People who have previously been treated with any selective oestrogen receptor degrader other than fulvestrant, or any experimental drug targeting the oestrogen receptor pathway
• People with active or ongoing corneal (eye surface) disease or other active eye conditions requiring treatment, where monitoring for drug effects on the eye would not be possible
• People with a history of drug, alcohol, or substance misuse
• People who have received live or weakened live vaccines within 4 weeks before the first dose; people who have used immune-modifying drugs (such as thymosin, interleukin-2, or interferon) within 14 days before the first dose; or people who have had an organ, stem cell, or bone marrow transplant from another person
• People the doctor considers unsuitable for the study for other reasons, including conditions such as epilepsy or dementia, concerns about ability to follow the study requirements, or any other circumstances the doctor believes make participation inadvisable

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