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:

• People aged 45 to 74 years old.
• Women who have gone through menopause, which the trial defines in several specific ways — including having had their ovaries removed, having had no periods for 12 or more months without being on contraception, or having had no periods for more than 2 months with a hormone blood test result (FSH) in the menopausal range. Some women with an IUD or who have had a hysterectomy may also meet this definition (confirm with trial site).
• Women under 55 with intact ovaries and a uterus must have a negative pregnancy test before joining.
• Women who are overweight or obese, meaning a body mass index (BMI) of 25 or higher, measured within 28 days of joining.
• People willing to have a fasting blood draw and a breast cell sampling procedure called an RPFNA (a type of fine needle sampling of breast tissue), with samples sent to the University of Kansas Medical Center.
• People at increased risk of breast cancer based on at least one of the following:
  • A personal history of certain non-cancerous but abnormal breast cell changes (atypical hyperplasia or lobular carcinoma in situ) found on biopsy.
  • A personal history of early-stage non-invasive breast cancer (DCIS) treated with mastectomy, lumpectomy, or local surgery, where treatment finished at least 3 months before the screening procedure.
  • High breast density on a mammogram, measured in specific ways (confirm with trial site).
  • A confirmed gene change (mutation) in one of these genes: ATM, BARD1, BRCA2, CDH1, CHEK2, NF1, PALB2, PTEN, RAD51C, RAD51D, or STK11.
  • A polygenic (multi-gene) lifetime risk score that is at least twice the average risk, or 25% or higher.
  • A five-year breast cancer risk score of 1.66% or more using a standard risk tool called BCRAT (version 2.0).
  • A ten-year breast cancer risk score of 3% or more using a standard tool called IBIS (version 8), or a relative risk score at least twice that expected for the person's age group using the same tool.
  • A ten-year risk score of 3% or more using the Breast Cancer Surveillance Consortium tool (version 2).
  • A close female or male relative (parent, sibling, child, grandparent, aunt, uncle, niece, nephew, half-sibling, grandchild, or first cousin) who was diagnosed with breast cancer before age 50.
  • Two or more close relatives (as described above) from either the mother's or father's side of the family diagnosed with breast cancer at any age.
  • A close relative (as described above) who had breast cancer in both breasts, or both breast and ovarian cancer, at any age.
• People with liver blood test results within acceptable ranges (specific numbers to be confirmed with trial site), tested within the past 6 months.
• People living with HIV who are on effective treatment with an undetectable viral load within the past 6 months.
• People with a history of chronic hepatitis B who have an undetectable viral level while on treatment (if treatment is needed).
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently on treatment with an undetectable viral level.
• People on long-term antiviral medication for the herpes simplex virus (cold sores or genital herpes).
• People who are generally well enough to carry out everyday activities, or with only minor limitations (confirm with trial site).
• Women who have at least one breast that has not been treated with radiation or surgery, available for the fine needle sampling procedure. Women who have had radiation or mastectomy on one side for early-stage non-invasive breast cancer may still be eligible.
• People who are willing and able to understand and sign a consent form.
• People whose most recent mammogram was done within the past 12 months and came back with a routine result (BIRADS 1 or 2), or who had follow-up imaging that confirmed a routine result.
• People who have had a fasting baseline blood sample (after at least 10 hours without eating) successfully received and stored at the University of Kansas Medical Center.

Who may not be able to join:

• People who have breast implants in both breasts.
• People with a personal history of invasive breast cancer.
• People with a personal history of invasive uterine cancer.
• People who have had another type of invasive cancer (other than common skin cancer) and have not finished cancer treatment, or still have signs of disease, within the past 2 years.
• People who are currently breastfeeding or who were breastfeeding within the past 12 months.
• People with type 1 or type 2 diabetes who are currently taking any diabetes medication, including metformin, GLP-1 medications, insulin, or sulfonylurea drugs.
• People with a history of deep vein thrombosis (blood clot in a vein), pulmonary embolism (blood clot in the lungs), or stroke.
• People who have had gastric bypass surgery.
• People with a history of chronic liver disease, including a condition called NASH or cirrhosis.
• People with a confirmed harmful gene change (mutation) in the BRCA1 or TP53 genes.
• People currently taking prescription blood thinners such as warfarin (Coumadin), rivaroxaban (Xarelto), apixaban (Eliquis), or heparin.
• People who are unable or unwilling to stop taking daily aspirin (81mg or more) at least 3 weeks before each breast sampling procedure. (Aspirin may be restarted 3 days after each procedure.)
• People who currently have a levonorgestrel IUD that has been in place for less than 2 years, or where removal is planned within the next 6 months.
• People currently using hormone therapy taken by mouth, skin patch, or injection. (Vaginal oestrogen is allowed.)
• People who have previously used tamoxifen, an aromatase inhibitor, or a selective oestrogen receptor degrader for more than 2 months. (People who took these for less than 2 months must have been off them for at least 6 months before starting screening tests.)
• People who have been taking more than 1 gram per day of omega-3 fatty acid supplements within the past 6 months.
• People currently taking prescription medications that suppress the immune system.
• People currently taking the strong CYP3A4-inducing drugs rifampin or aminoglutethimide (confirm with trial site).
• People currently using a GLP-1 medication (such as those used for weight loss or blood sugar control) or planning to start one within the next 6 months.
• People currently taking metformin for any reason.
• People currently taking part in another clinical trial involving an investigational treatment.
• People with a known allergy to tamoxifen, omega-3 fatty acids, or chemically similar compounds.
• People with a serious uncontrolled illness, or mental health or personal circumstances that would make it difficult to follow the trial requirements.

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