[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-lobular-carcinoma-in-situ\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-lobular-carcinoma-in-situ":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,71,96],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100530282","phase-2-finding-the-best-tamoxifen-dose-for-breast-cancer-risk-reduction-in-premenopausal-women-renaissance-trial-100530282",false,"NCT06184750","Finding the Best Tamoxifen Dose for Breast Cancer Risk Reduction in Premenopausal Women, RENAISSANCE Trial","Refining Tamoxifen Dose for Premenopausal Breast Cancer Risk Reduction (RENAISSANCE): A Phase II Single Arm Trial","Inclusion Criteria:\n\n* Premenopausal women at the time of enrollment defined by any of the following:\n\n  * Age under 50 years and regular menstruation (most recent period within the past 3 months)\n  * Age under 50 years and continuous hormonal contraception use and at least one intact ovary\n  * Women who are not postmenopausal based on serum hormone levels. Women with estradiol =\\\u003C 30 pg\u002FmL, follicle-stimulating hormone (FSH) \\>= 30 IU\u002FmL are eligible\n* Women with any of the following:\n\n  * A history of unilateral estrogen receptor (ER) positive ductal carcinoma in situ (DCIS) with local therapy completed (as determined by treating physician recommendation and patient acceptance) at least 1 month prior to study entry. (The untreated breast will be the study breast, for both imaging and optional biopsy)\n  * Recent or prior lobular carcinoma in situ (LCIS), or any form of epithelial atypia, flat epithelial (FEA), atypical ductal hyperplasia (ADH), or atypical lobular hyperplasia (ALH)\n  * Are risk eligible for preventive medication based on a five-year risk of 1.7% or greater, estimated with a validated model: the National Cancer Institute (NCI) Breast Cancer Risk Assessment Tool, Tyrer-Cusick, Breast Cancer Surveillance Consortium. If the Tyrer-Cuzick model is used a ten-year risk of 3.4% or greater is acceptable\n  * Are tamoxifen-eligible by American Society of Clinical Oncology (ASCO) guidelines (\\>= 2-fold increased risk compared to peer if age \\>= 45 years, and \\>= 4-fold increased risk if age \\\u003C 45 years)\n  * A history of mantle radiotherapy\n  * A moderate penetrance germline pathogenic variant\n* Participants ≥ 18 and ≤ 55 years old will be enrolled. Our trial objectives are not relevant to females under 18 years of age since breast cancer is extraordinarily rare in this age group, and there are no guidelines regarding use of tamoxifen in children, even if know to be at very high risk for breast cancer when older. Because no dosing or adverse event (AE) data are currently available on the use of tamoxifen in participants \\\u003C 18 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status must be =\\\u003C 2 (Karnofsky \\>= 60%)\n* Human immunodeficiency virus (HIV)-infected patients are eligible to participate if they are on effective anti-retroviral therapy with undetectable viral load within the prior 6 months\n* Women with evidence of chronic hepatitis B virus (HBV) infection, are also eligible if the HBV viral load is undetectable; they may be on suppressive therapy, if indicated\n* Women with a history of hepatitis C virus (HCV) infection are eligible if treated and cured. For those who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Women with herpes simplex virus (HSV) infection are eligible if on chronic or as needed (due to a flare) suppressive antiviral therapy\n* Hormonal contraceptive users are eligible and should maintain the same oral contraceptive preparation throughout the duration of the trial. For women who have a levonorgestrel-coated intra-uterine device, removal for medical reasons will be allowed\n* The effects of tamoxifen on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because tamoxifen is known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately\n* Ability to understand and the willingness to sign a written informed consent document\n* Breast Imaging Reporting and Data System (BIRAD) 1 or 2. If BIRAD 0, follow-up diagnostic imaging must be BIRAD 1 or 2 or cleared clinically with radiology recommendation of return to annual screening\n* Women who are factor V leiden carriers and have not had a blood clot are eligible, if approved by their treating physician\n\nExclusion Criteria:\n\n* BIRADS breast density category A on most recent mammogram\n* History of selective estrogen receptor modulator (SERM) use within the past 5 years unless:\n\n  * Use was less than 6 months duration in the past 5 years and not used in the 1 year prior to enrollment OR\n  * Use was no greater than 2 months duration in the past 1 year and not used in the 6 months prior to enrollment\n* History of invasive breast cancer\n* Prior bilateral mastectomy or breast augmentation surgery including breast implants. Prior bilateral excisional surgical biopsy, mastopexy (breast lift) or mammoplasty (breast reduction) is allowed, as long as \\> 1 year has passed since the procedure\n* Women with \"mosaic mammographic screening views\", i.e., whose larger breast size precludes being imaged within a single mammographic screening view\n* Current use of a strong CYP3A4 inducer or a strong CYP2D6 inhibitor unless willing and able to discontinue use and switch to an alternative medication for the duration of participation, under the advice of their physician. If the physician believes the current medication cannot be replaced, the participant will not be eligible\n* Current use of Warfarin\n* Planning to become pregnant within the next two years. Potential study participants will be questioned about this and excluded if they are planning pregnancy over the next 20 months\n* History of thromboembolism, pulmonary embolism, thrombotic stroke, arterial thrombosis of the extremity or deep vein thrombosis. A history of superficial thrombophlebitis is allowed\n* History of uterine cancer or atypical uterine hyperplasia with uterus intact\n* Participants may not be receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to tamoxifen\n* Uncontrolled intercurrent illness or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant women are excluded from this study because tamoxifen a category D agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with tamoxifen. Breastfeeding should be discontinued if the mother is treated with tamoxifen\n* Women with known gene mutations associated with an increased risk for breast cancer such as BRCA1\u002F2, CDH1, PALB2, PTEN, STK11, or P53\n* Current use of sex hormones (estrogen, progesterone, or androgens), unless part of oral contraception pills\n* Prior invasive cancer, unless curatively treated, and all treatment was completed \\> 5 years prior to enrollment","FEMALE","18 Years","55 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This phase II trial evaluates response-guided low-dose tamoxifen for reducing breast density in women who are at higher than average risk for breast cancer. Increasing breast density is a well established risk factor for breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works by blocking the effects of the hormone estrogen in the breast. Tamoxifen has been shown to reduce breast density, even at reduced dosages, and is approved for the prevention of breast cancer.",[27,28,29,30,31,32],"Breast Atypical Ductal Hyperplasia","Breast Atypical Lobular Hyperplasia","Breast Carcinoma","Breast Ductal Carcinoma In Situ","Breast Lobular Carcinoma In Situ","Estrogen Receptor-Positive Breast Carcinoma","RECRUITING","2026-06-16",{"date":36,"type":37},"2026-06-17","ACTUAL",{"date":39,"type":37},"2024-09-27",{"date":41,"type":21},"2028-09-30",{"name":43,"class":44},"National Cancer Institute (NCI)","NIH",11,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100452975","impact-of-dietary-inflammatory-potential-on-breast-cancer-risk-100452975","NCT05178498","Impact of Dietary Inflammatory Potential on Breast Cancer Risk","Longitudinal Study Evaluating the Impact of Dietary Inflammatory Potential on Breast Cancer Risk in a Cohort of Women Followed in the Breast Cancer Prevention Clinic at the Ohio State University Comprehensive Cancer Center- James Cancer Hospital and Solove Research Institute","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Established in the high risk clinic at OSUCCC- James (includes patients with family history of breast cancer \\[BC\\], known genetic predisposition, personal history of known atypia\u002Fbreast lobular carcinoma in situ \\[LCIS\\], or prior chest wall radiation)\n* Patients at high risk for BC established in the surgical oncology clinic at Stefanie Spielman Comprehensive Breast Center (SSCBC), with one of the following diagnoses: Atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), lobular carcinoma in situ (LCIS), sclerosing adenosis (SA), or radial scars (RS)\n* Able to read and understand English\n* Able to provide informed consent\n* Must consent to continued follow-up of medical records during the study period\n\nExclusion Criteria:\n\n* Prisoners\n* Not able to speak and understand English\n* Known personal history of ductal carcinoma in situ (DCIS) or Invasive BC","ALL",{"count":55,"type":21},960,"OBSERVATIONAL","This study evaluates the association of dietary inflammatory potential with breast cancer risk. Information collected in this study may help doctors to identify modifiable risk factors, screen high risk patients early, improve prevention strategies, and provide timely intervention for early therapeutic management as needed.",[27,28,29,31,59],"Breast Sclerosing Adenosis","2026-06-10",{"date":62,"type":37},"2026-06-12",{"date":64,"type":37},"2023-10-25",{"date":66,"type":21},"2035-12-31",{"name":68,"class":69},"Ohio State University Comprehensive Cancer Center","OTHER",1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":16,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100531093","phase-2-low-dose-tamoxifen-with-or-without-omega-3-fatty-acids-for-breast-cancer-risk-reduction-100531093","NCT06195306","Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction","Phase 2 Study of Low Dose Tamoxifen +\u002F- High Dose Omega-3 Fatty Acids in Overweight Postmenopausal Women at Increased Risk for Breast Cancer","Inclusion Criteria:\n\n* Age 45 - 74\n* Postmenopausal female\n\n  * Postmenopausal is defined as either\n\n    * Prior removal of the ovaries, or if ovaries intact amenorrhea for \\>= 12 months and not on any form of contraception, or\n    * Amenorrhea for greater than 2 months with serum follicle-stimulating hormone (FSH) in postmenopausal range (\\>= 25 IU\u002FL). Women with ovaries and a prior hysterectomy or endometrial ablation \\\u003C age 55 must have a FSH \\>= 25 IU\u002FL. Women may be on vaginal low dose estrogen preparations for vaginal dryness. Women over age 50 with a levonorgestrel intrauterine device in place for 2 or more years and not planning removal in the next 6 month are also eligible if FSH \\>= 25 IU\u002FL\n\n      * Note: FSH will be done at time of screening\n* Women with intact ovaries and uterus \\\u003C age 55 must have a negative pregnancy test prior to randomization\n* Overweight or obese (body mass index \\[BMI\\] \\>= 25 kg\u002Fm\\^2)\n\n  * Note: BMI must be calculated within 28 days of randomization\n* Willing to undergo a fasting blood draw and non-fasting RPFNA with fixed and frozen aliquots sent to University of Kansas Medical Center (KUMC)\n* At increased risk of breast cancer per at least one of the following:\n\n  * Personal medical history\n\n    * History of atypical hyperplasia or lobular carcinoma in situ (LCIS) found on breast biopsy\n    * History of unilateral ductal carcinoma in situ treated with unilateral mastectomy, lumpectomy, or local excision with or without radiation and this treatment was completed at least 3 months prior to the screening RPFNA\n    * High mammographic density determined by one of the following:\n\n      * Visual estimate of area of density (VAS) \\> 50%,\n      * Volpara (trademark) \\>= 15% dense volume (Volpara d)\n      * Breast Imaging Reporting and Data System (BIRADS) assessment = extremely dense (BIRADs D)\n  * Genetic test result\n\n    * Germline gene mutation in ATM, BARD1, BRCA2, CDH1, CHEK2, NF1, PALB2, PTEN, RAD51C, RAD51D, or STK11\n    * Polygenic lifetime risk score \\>= 2x average or 25%\n  * Calculated risk based on standard models\n\n    * Five-year Breast Cancer Risk Assessment Tool (BCRAT) (version 2.0) \\>= 1.66%\n    * Ten-year International Breast Cancer Intervention Study risk evaluation tool (IBIS) (version 8) \\>= 3%\n    * Ten-year relative risk IBIS (version 8) \\>= 2X that for age group\n    * Ten- year Breast Cancer Surveillance Consortium (version 2) \\>= 3%\n  * Family History\n\n    * Breast cancer in a first or second degree relative (female or male) with onset under age 50. (First degree relative = parent, sibling, or child. Second degree relative = grandparent, uncle, aunt, nephew, niece, half-sibling, grandchild or first cousin)\n    * Breast cancer in two or more first or second-degree relatives from either the maternal or paternal linage without regard to age\n    * Bilateral breast cancer or breast and ovarian cancer in the same first or second degree relative without regard to age\n  * Primary source documentation of risk is required and must be submitted to the lead academic organization (LAO) for review along with the eligibility checklist\n\n    * Risk factor: Atypical hyperplasia or LCIS; Primary source document: Copy of pathology report or clinical note confirming the diagnosis\n    * Risk factor: Ductal carcinoma in situ (DCIS) and treatment history; Primary source document: Copies of pathology report or clinic notes confirming the diagnosis, treatment plan and treatment end date(s)\n    * Risk factor: Mammographic density; Primary source document: Copy of clinic note or mammogram report\n    * Risk factor: Genetic; Primary source document: Copy of genetic test report\n    * Risk factor: Calculated based on standard models; Primary source document: Copy of the calculation result\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN)\n\n  * Note: Higher total bilirubin levels (=\\\u003C 3 mg\u002FdL) can be allowed if due to known benign liver condition, i.e., Gilbert's syndrome\n  * Results from prior laboratory testing within 180 days of randomization may be used\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) =\\\u003C 3.0 x institutional upper limit of normal\n\n  * Results from prior laboratory testing within 180 days of randomization may be used\n* Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3.0 x institutional upper limit of normal\n\n  * Results from prior laboratory testing within 180 days of randomization may be used\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 60%)\n* Women must have at least 1 unaffected untreated breast for fine needle aspiration. Women may have had prior unilateral breast radiation or mastectomy for DCIS\n* Ability to understand and the willingness to sign a written informed consent document\n* Most recent screening mammogram must be performed ≤ 12 months prior to RPFNA and must be reported as BIRAD 1 or 2. If BIRAD 0 then follow-up diagnostic imaging must be BIRAD 1 or 2 or cleared clinically with radiology recommendation of return to annual screening\n* Confirmation that baseline research blood was drawn fasting (\\>= 10 hours), has been received in good condition at KUMC, and is archived for assessment of primary endpoint\n\nExclusion Criteria:\n\n* Exclusions based on current or past conditions:\n\n  * Bilateral breast implants (danger of implant puncture with RPFNA)\n  * Prior invasive breast cancer\n  * Prior invasive uterine cancer\n  * Other prior invasive cancer and haven't completed cancer related therapy or with evidence of disease (other than non-melanoma skin cancer) within the past 2 years\n  * Currently breastfeeding (concern that tamoxifen may be in breast milk) or nursing within past 12 months (concern about milk fistula with RPFNA)\n  * Type I or type II diabetes mellitus requiring current pharmacologic treatment (including metformin, glucagon-like peptide 1 agonists, insulin, sulfonylurea)\n  * Prior deep vein thrombosis, pulmonary embolus, or stroke\n  * Prior gastric bypass surgery\n  * History of chronic liver disease including NASH (nonalcoholic steatohepatitis) or cirrhosis\n  * Pathogenic or likely pathogenic germline mutation in BRCA1 or TP53\n* Exclusions based on medications:\n\n  * Current use of prescription anticoagulants such as Coumadin (warfarin), direct-acting oral anticoagulants such as Xarelto (rivaroxaban) or Eliquis (apixaban) or heparin\n  * Women who would not be able to or do not wish to discontinue daily use of aspirin (81mg or higher) and aspirin containing products (81 mg or higher) at least 3 weeks prior to each RPFNA\n\n    * Note: Women may resume daily use of aspirin and aspirin containing products 3 days after each RPFNA procedure\n  * Current use of a levonorgestrel intrauterine device if in place less than 2 years or if there is planned removal within the next 6 months\n  * Current use of hormone therapy (oral, transdermal, or injectable)\n\n    * Note: Vaginal estrogen is allowed\n  * Prior treatment with tamoxifen, aromatase inhibitor or selective estrogen receptor degrader for more than 2 months\n\n    * Note: Women with \\\u003C 2 months of these drugs must be off for at least 6 months before they may begin biomarker screening tests\n  * Greater than 1 gram daily of omega-3 fatty acid supplement within the last 6 months\n  * Current use of prescription immunosuppressive drugs\n  * Current use of CYP3A4 strong inducers rifampin or aminoglutethimide\n  * Current use of or plans to initiate a glucagon-like peptide 1 agonist within the next 6 months\n  * Current use of metformin for any indication\n* Participants may not be receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to tamoxifen or omega-3 fatty acid or generic Lovaza or compounds of similar chemical composition\n* Uncontrolled intercurrent illness or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",true,"45 Years","74 Years",{"count":82,"type":21},66,[24],"This phase II trial evaluates tamoxifen, with or without omega-3 fatty acids, for reducing risk of breast cancer among postmenopausal and overweight or obese women who are at increased risk of developing breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works by blocking the effects of the hormone estrogen in the breast. Tamoxifen is approved by the Food and Drug Administration for prevention of breast cancer in women at increased risk. Omega-3 fatty acids have been shown to decrease the amount of fats made in the liver. Omega-3 fatty acids may work to prevent cancer in overweight or obese individuals. Tamoxifen with or without omega-3 fatty acids may be effective at reducing risk of breast cancer among women who are postmenopausal, overweight or obese, and at increased risk.",[86,29,30,31],"Breast Atypical Hyperplasia","2026-05-19",{"date":89,"type":37},"2026-05-20",{"date":91,"type":37},"2025-07-28",{"date":93,"type":21},"2028-01-01",{"name":43,"class":44},3,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":103,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":5},"100511598","phase-2-acolbifene-versus-low-dose-tamoxifen-for-the-prevention-of-breast-cancer-in-premenopausal-women-at-high-risk-for-development-of-breast-cancer-100511598","NCT05941520","Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High Risk for Development of Breast Cancer","Phase IIA Trial of Acolbifene (20 mg) vs Low Dose Tamoxifen (5 mg) in Pre-menopausal Women at High Risk for Development of Breast Cancer","Inclusion Criteria:\n\n* Age \\>= 35 years\n* Considered clinically premenopausal\n* Having regular menstrual cycles (between 21 and 35 days) unless a contraceptive device such as progestin containing intrauterine device (IUD) (e.g., Mirena IUD) is being used which suppresses menstrual periods, or premenopausal women who have undergone a hysterectomy, but ovaries are intact\n* Not considering pregnancy for at least 12 months\n* Women of child-bearing potential capacity must be willing to have used effective birth control precautions for 8 weeks prior to fine needle aspiration and be willing to continue for 8 weeks after study completion as tamoxifen may have teratogenic effects on the developing fetus. Reproductive and developmental toxicity studies have not been conducted with acolbifene. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must stop study drug and inform her study physician immediately.\n\n  * For women not using oral contraceptive (progestin alone or estrogen plus a progestin), two of the following are recommended but woman must agree to at least one of the following methods:\n\n    * IUD non-hormonal or hormone containing (usually a progestin) intrauterine device (IUD) or rings. Any of these should have been inserted at least 8 weeks prior to RPFNA.\n    * Barrier method (such as condoms and diaphragms or cervical caps with or without a spermicide)\n    * Partner has had a vasectomy.\n  * For women using oral contraceptive (progestin alone or estrogen plus a progestin), woman must agree to at least a non- hormonal IUD or a barrier method (below) or her partner must have had a vasectomy:\n\n    * Non-hormonal IUD\n    * Barrier method (such as condoms and diaphragms or cervical caps with or without a spermicide)\n    * Partner has had a vasectomy\n* Must have increased breast cancer risk as predicted by any one or more of the conditions listed below or increased model calculated risk as below:\n\n  * Any one or more of the following conditions associated with increased risk (condition must be documented in electronic medical record or copy of relevant pathology or genetic testing reports submitted with the eligibility checklist)\n\n    * A prior biopsy at any time in the past showing ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), atypical hyperplasia. (If DCIS must have been treated by mastectomy or local excision +\u002F- radiation with this treatment completed at least 3 months prior to screening with RPFNA)\n    * High or moderate penetrance risk pathogenic or likely pathogenic germline gene mutation in ATM, BARD1, BRIP1, CDH1, CHEK2, MSH6, NBN, NF1, PTEN, PMS2, RAD51C, RAD51D, or TP53\n    * High polygenic risk score (Life-time risk of \\>= 2x average or 25%)\n    * Breast cancer in a first or second degree relative (female or male) with onset under age 50. First degree relative is defined as parent, sibling, or child. Second degree relative is defined as grandparent, uncle, aunt, nephew, niece, half-sibling, grandchild or first cousin\n    * Two or more affected first or second-degree relatives from either the maternal or paternal lineage without regard to age\n    * Bilateral breast cancer or breast and ovarian cancer in the same first or second degree relative without regard to age.\n    * High mammographic density defined as either visual estimate of area of density (VAS) \\> 50%, or Volpara (Trademark) \\>= 15% dense volume (Volpara d) or Breast Imaging Reporting and Data System (BIRADS) assessment of extremely dense (BIRADs D)\n  * Alternatively, instead of conditions listed above, an increased risk of breast cancer as calculated by International Breast Cancer Intervention Study Version 8 (IBIS 8), or Breast Cancer Surveillance Consortium (BCSC) 3 by one or more of the following criteria:\n\n    * 10-year risk of breast cancer of \\>= 3%\n    * Increase in age specific 10-year relative risk by age group\n\n      * Age 35-39 10-year relative risk of \\>= 5X that for age group\n      * Age 40-44 10-year risk of \\>= 4X that for age group\n      * Age 45 and up 10-year risk of \\>= 2X\n    * IBIS Version 8 Remaining lifetime risk of \\>= 25% or \\>= 2X that of population\n  * A copy of the output of model calculations from IBIS 8 (https:\u002F\u002Fems-trials.org\u002Friskevaluator\u002F), or BCSC version 3.0 (https:\u002F\u002Ftools.bcsc-scc.org\u002FBC5yearRisk\u002Fcalculator.htm) online tools, if used for qualifying risk assessment, or polygenetic risk score should be submitted with the eligibility checklist. Otherwise, these risk qualifying factors need to be documented in the medical record if that is considered the source document\n* Women must have at least 1 unaffected untreated breast for fine needle aspiration. Women may have had prior unilateral breast radiation or mastectomy for DCIS\n* Eastern Cooperative Oncology Group (ECOG) current performance status (PS) ≤ 2 as documented within 3 months prior to randomization or Karnofsky score \\>= 60%\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (measured within 180 days prior to randomization)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) =\\\u003C 1.5 x institutional upper limit of normal (measured within 180 days prior to randomization)\n* Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 1.5 x institutional upper limit of normal (measured within 180 days prior to randomization)\n* Creatinine =\\\u003C 2.0 mg\u002FdL (measured within 180 days prior to randomization)\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Bilateral breast implants (danger of implant puncture with RPFNA)\n* Women who are pregnant\n* Currently breastfeeding (concern that tamoxifen or acolbifene may be in breast milk) or nursing within the past 12 months (concern about milk fistula with RPFNA)\n* Prior invasive breast cancer within the past 5 years\n* Other prior invasive cancer \\> T1 stage (other than non-melanoma skin) within the past 5 years\n* Pathogenic or likely pathogenic germline mutation in BRCA1\u002F2 or PALB2 (These latter individuals are likely to undergo yearly ovarian screening and enlarging cysts could raise concern about ovarian cancer and lead to unnecessary diagnostic procedures)\n* Type I or Type II diabetes mellitus requiring treatment with prescription medication\n* Prior deep vein thrombosis, pulmonary embolus, or stroke\n* History of chronic liver disease including NASH (nonalcoholic steatohepatitis) and chronic hepatitis C\n* History of chronic hepatitis B or hepatitis C (danger of exacerbation of liver damage from hepatitis or tamoxifen-induced non-alcoholic fatty liver disease or non-alcoholic steatohepatitis)\n* History of human immunodeficiency virus (HIV)-infection (danger of exacerbation of underlying clinically inapparent liver damage caused by HIV and\u002For hepatotoxicity can be induced by interaction of tamoxifen-induced CYP3A4 with direct anti-hepatitis C virus \\[HCV\\] agents)\n* Current use of prescription anticoagulants such as Coumadin (warfarin), direct-acting oral anticoagulants such as Xarelto (rivaroxaban) or Eliquis (apixaban), or heparin\n* Women who would not be able to or do not wish to discontinue daily use of aspirin (81 mg or higher) and aspirin containing products (81 mg or higher) at least 3 weeks prior to each RPFNA are not eligible. Women who would be able to stop daily use of aspirin and aspirin containing products at least 3 weeks prior to each RPFNA are eligible\n\n  * NOTE: Women may resume daily use of aspirin and aspirin containing products 3 days after each RPFNA procedure\n* Starting or stopping oral contraceptives (OCs) or hormonal progestin IUDs within 8 weeks of baseline RPFNA\n* Current use or use within the prior 8 weeks of progesterone\u002Fprogestin injections or progestin implants (due to concerns about high levels of progestin and lack of safety and efficacy data with low dose tamoxifen)\n* Current use of other investigational agents\n* Prior treatment with acolbifene for more than 2 months\n* Prior treatment with tamoxifen for more than 2 months\n* Current use of prescription immunosuppressive drugs\n* History of allergic reactions attributed to tamoxifen or acolbifene or compounds of similar chemical composition\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study","35 Years",{"count":105,"type":21},80,[24],"This phase IIA trial compares the effect of acolbifene versus low dose tamoxifen in preventing breast cancer in premenopausal women at high risk for developing breast cancer. The usual approach for patients at increased risk for breast cancer is to undergo yearly breast magnetic resonance imaging or ultrasound in addition to yearly mammogram. Premenopausal women at very high lifetime risk for breast cancer (greater than 50%) can consider preventive removal (mastectomy) of both breasts. Premenopausal women age 35 or older with a prior diagnosis of atypical hyperplasia, lobular carcinoma in situ, or an estimated 10-year risk of greater than or equal to 3% or estimated 10-year risk of greater than or equal to 2-5 times that of the average woman (depending on age) may be advised to consider five years of standard dose tamoxifen. Standard dose tamoxifen is four times the dose used in this study. Estrogen can cause the development and growth of breast cancer cells. Acolbifene and tamoxifen blocks the use of estrogen by breast cells. This study may help researchers measure the effects of acolbifene and low dose tamoxifen on markers of breast cancer risk in mammogram imaging, breast tissue, and in blood samples.",[86,29,30,31],"2026-05-12",{"date":111,"type":37},"2026-05-13",{"date":113,"type":37},"2024-08-23",{"date":115,"type":21},"2028-09-01",{"name":43,"class":44}]