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 35 years of age or older.
• People who are premenopausal (have not yet gone through menopause), as determined by a doctor.
• People who have regular menstrual cycles (every 21 to 35 days), or whose periods are suppressed by a hormonal IUD (such as a Mirena) or oral contraceptives, or who have had their uterus removed but still have at least one ovary.
• People who are not planning to become pregnant for at least 12 months.
• People who are sexually active with a male partner and are able to use at least one reliable form of birth control for 8 weeks before and 8 weeks after the study, due to potential risks to a developing baby from the study drugs.
• People who have at least one breast that has not been treated or affected by cancer, available for a needle sampling procedure.
• People whose breast cancer risk is elevated, based on one or more of the following (as confirmed by medical records or test reports):
  • A past breast biopsy showing a non-cancerous but high-risk finding, such as DCIS (treated at least 3 months before the study), LCIS, or atypical hyperplasia.
  • A confirmed high- or moderate-risk gene change (variant) in certain genes, including ATM, BRCA2, PALB2, CHEK2, or several others listed in the criteria (confirm with trial site for full list).
  • A high polygenic risk score showing a lifetime breast cancer risk of 25% or more, or at least twice the average risk.
  • A close family member (parent, sibling, child, grandparent, aunt, uncle, cousin, or similar) diagnosed with breast cancer before age 50.
  • Two or more close family members (on either side of the family) diagnosed with breast cancer at any age.
  • A close family member who had breast cancer in both breasts, or both breast and ovarian cancer.
  • Very high breast density on a mammogram, based on specific measurements.
  • Radiation treatment to the chest area before age 30.
  • A 10-year breast cancer risk of 3% or more, or a significantly elevated age-specific risk, as calculated by recognised risk assessment tools (IBIS 8 or BCSC).
  • A lifetime risk of 25% or more as calculated by the IBIS Version 8 tool.
• People who are generally well enough to carry out everyday activities, based on a standard health performance assessment done within 3 months before joining.
• People with liver and kidney blood test results within acceptable ranges, tested within 6 months before joining.
• People who are willing and able to attend all scheduled visits, follow the study plan, and complete required tests and procedures.
• People who understand the study and are willing to sign a written consent form.
• People whose tissue samples, collected by needle procedure, have been confirmed as received in good condition at the study laboratory.
• People whose breast density imaging data has been received or archived at the study site in the required format.

Who may not be able to join:

• People who have breast implants in both breasts.
• People who are currently pregnant.
• People who are currently breastfeeding, or who have breastfed within the past 12 months.
• People who have had an invasive breast cancer diagnosis within the past 5 years.
• People who have had another invasive cancer (other than certain common skin cancers) of a certain size or stage within the past 5 years (confirm with trial site).
• People who have a confirmed high-risk gene change in the BRCA1 gene.
• People who have Type 1 or Type 2 diabetes managed with prescription medication.
• People who have had a blood clot in a deep vein, a blood clot in the lungs, or a stroke.
• People with a history of chronic liver disease, including a condition called NASH, or chronic hepatitis C.
• People with a history of chronic hepatitis B or hepatitis C.
• People with a history of HIV infection.
• People currently taking prescription blood-thinning medications, such as warfarin (Coumadin), rivaroxaban (Xarelto), apixaban (Eliquis), or heparin.
• People who, due to a medical condition, cannot stop taking daily aspirin (81 mg or more) at least 3 weeks before each needle sampling procedure.
• People who have started or stopped the oral contraceptive pill or a hormonal IUD within 8 weeks of the initial needle sampling procedure.
• People who are currently using, or have used within the past 8 weeks, progestin injections or progestin implants.
• People who are currently taking part in another clinical trial involving an investigational drug.
• People who have previously taken acolbifene (one of the study drugs) for more than 2 months.
• People who have previously taken tamoxifen (one of the study drugs) for more than 2 months.
• People currently taking prescription medications that suppress the immune system.
• People with a known allergic reaction to tamoxifen, acolbifene, or chemically similar compounds.
• People with serious uncontrolled health conditions, such as active infection, heart failure, unstable chest pain, irregular heartbeat, or mental health conditions that could affect participation in the study.
• People who have used certain weight or blood sugar medications known as GLP-1 or GIP receptor agonists (such as medications used for type 2 diabetes or weight management) within 8 weeks of joining, or who plan to use them during the study (confirm with trial site).

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