Phase 2 Breast Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Women who are postmenopausal — meaning no menstrual periods for at least 12 months without another medical explanation, or who have had a hysterectomy, both fallopian tubes removed, or both ovaries removed.
• Women who meet at least one of the following risk-related conditions: a recent diagnosis (within the last 12 months) of a specific non-invasive breast condition called DCIS (with ER+ status above 5%) where the tumour was surgically removed with clear margins followed by radiation; OR a diagnosis within the past 3 years of certain high-risk breast tissue changes (ADH, LCIS, or ALH); OR a calculated breast cancer risk of at least 3% over 5 years (or 5% over 10 years) based on specific approved risk tools; OR a confirmed genetic variant in the CHEK2 or ATM genes; OR a history of chest wall radiation treatment received before age 30.
• People with a general health and activity level rated as fully active or restricted only in physically strenuous activity (confirm with trial site).
• People who are able to swallow tablets or capsules.
• People who have had another cancer diagnosed 3 or more years ago (excluding breast and endometrial cancers), where that cancer or its treatment is unlikely to affect the trial assessment.
• People who are willing and able to understand and sign a written consent form.
• People who have had a mammogram within the 6 months before signing the trial consent form.
• People who have had a bone density scan (DEXA) within the 12 months before signing the trial consent form.
• People with a life expectancy of 10 years or more.
• People with normal liver function and normal blood cell counts.
• People who have had a gynaecological examination with a negative result within the 6 months before signing the trial consent form.

Who may not be able to join:

• Women who are pre-menopausal or in the transition period around menopause (perimenopause).
• People with a history of deep vein thrombosis (blood clots in the veins) or pulmonary embolism (blood clots in the lungs).
• People who have had endometrial (uterine) cancer.
• People with a disorder affecting the macula in the eye.
• People who are unable to follow the study procedures.
• People who have used anti-oestrogen medications within the 12 months before signing the consent form.
• People who have used hormone replacement therapy (HRT) within the 3 months before signing the consent form.
• People with severe osteoporosis (based on a specific bone density score) or a recent spinal fracture within the past 6 months that has not been treated with specific bone-strengthening medications (confirm with trial site).
• People currently taking any of the following medications: terbinafine, quinidine, cinacalcet, rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's Wort, warfarin, erythromycin, cyclosporin, nifedipine, or any coumarin-type blood-thinning medication.
• People with moderate or severe kidney impairment.
• People with a known allergy or sensitivity to the study medications.

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