[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-ductal-carcinoma-in-situ\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-ductal-carcinoma-in-situ":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,45,78,103,125,149,176,199,221,247,271],{"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":5},"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",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100619029","a-novel-fluorescent-ductal-needle-for-localization-and-sampling-of-micro-lesions-in-breast-ducts-100619029","NCT07339306","A Novel Fluorescent Ductal Needle for Localization and Sampling of Micro Lesions in Breast Ducts","A Novel Fluorescent Ductal Needle With Controllable Detachment for Realtime Localization and Sampling of Micro Lesions in Breast Ducts: a Prospective, Multicenter Study","Inclusion Criteria:\n\n1. Female patients aged 18-75 years.\n2. Patients scheduled to undergo duct excision surgery.\n3. Patients who are capable of providing written informed consent and adhering to the study protocols.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding.\n2. Patients who have known allergy to quantum-dot materials or localization needle components.\n3. Patients with active hepatitis B or C infection with detectable viral load.\n4. Patients with unstable cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia, NYHA class III-IV heart failure).\n5. Patients with history of neurological or psychiatric disorders that may impair compliance (e.g., epilepsy, dementia).\n6. Patients who concurrent participation in another interventional clinical trial.","75 Years",{"count":54,"type":21},300,[56],"NA","This prospective, multicenter cohort study investigates the differences in the reliability of rapid pathology compared to postoperative pathology when utilizing a novel fluorescent localization needle equipped with a controllable shedding quantum dot chiral nanofluorescent coating, in contrast to traditional localization techniques for breast duct lesions. The principal objective is to assess the clinical efficacy of this innovative fluorescent localization needle in enabling precise pathological diagnosis of micro lesions in breast ducts.",[59,60,30],"Mammary Tumor","Nipple Discharge",[62,63,64,65,66],"micro lesions","breast duct","fluorescent ductal needle","localization needle","controllable detachment","2026-06-10",{"date":69,"type":37},"2026-06-11",{"date":71,"type":37},"2026-01-01",{"date":73,"type":21},"2026-09-30",{"name":75,"class":76},"The Fourth Affiliated Hospital of China Medical University","OTHER",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":16,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"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":89,"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.",[93,29,30,31],"Breast Atypical Hyperplasia","2026-05-19",{"date":96,"type":37},"2026-05-20",{"date":98,"type":37},"2025-07-28",{"date":100,"type":21},"2028-01-01",{"name":43,"class":44},3,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":110,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},"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":112,"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.",[93,29,30,31],"2026-05-12",{"date":118,"type":37},"2026-05-13",{"date":120,"type":37},"2024-08-23",{"date":122,"type":21},"2028-09-01",{"name":43,"class":44},4,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":124},"100375518","impact-of-covid-19-pandemic-on-out-of-pocket-costs-lost-wages-and-unemployment-in-patients-with-breast-cancer-undergoing-breast-surgery-100375518","NCT04169542","Impact of COVID-19 Pandemic on Out-of-Pocket Costs, Lost Wages, and Unemployment in Patients With Breast Cancer Undergoing Breast Surgery","Potential Impact of the COVID -19 Pandemic on Financial Toxicity in Breast Cancer Surgical Patients: The Impact on Out of Pocket Costs, Lost Wages and Economic Strain","Inclusion Criteria:\n\n* Have an indication for surgical treatment of invasive breast cancer or ductal breast carcinoma in situ (DCIS) or prophylaxis in the setting of genetic mutations or strong family history\n* English-speaking\n* Able to complete consent\n* Able to fill out computer survey material\n\nExclusion Criteria:\n\n* Non-English-speaking\n* Those with recurrent or metastatic disease or concurrent primary cancers\n* Patients undergoing breast conservation therapy will also be excluded from the study",{"count":133,"type":21},600,"OBSERVATIONAL","This study investigates the impact of COVID-19 pandemic on out-of-pocket costs, lost wages, and unemployment in patients with breast cancer undergoing breast surgery. Post-mastectomy reconstructive patients are at high risk for financial toxicity (adverse effects of escalating health care cost on well-being). The goal of this study is to collect information about financial costs patients may have as a result of surgical treatment for cancer with or without breast reconstruction and to learn if COVID-19 affects patient costs of breast reconstruction. This may help researchers demonstrate the financial consequences of undergoing breast surgery.",[30,137,138,139],"COVID-19 Infection","Hereditary Breast Carcinoma","Invasive Breast Carcinoma","2026-04-28",{"date":142,"type":37},"2026-05-04",{"date":144,"type":37},"2019-05-21",{"date":146,"type":21},"2028-03-31",{"name":148,"class":76},"M.D. Anderson Cancer Center",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":77},"100557459","phase-2-high-cannabidiol-plant-extract-brc-001-to-improve-aromatase-inhibitor-induced-arthralgia-in-women-with-breast-cancer-100557459","NCT06538389","High Cannabidiol Plant Extract (BRC-001) to Improve Aromatase Inhibitor-Induced Arthralgia in Women With Breast Cancer","High Cannabidiol (CBD) Standardized Extract for Aromatase Inhibitor-Induced Arthralgia - A Randomized Controlled Double Blind Clinical Trial","Inclusion Criteria:\n\n* Documented informed consent of the participant\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Postmenopausal by last menses \\> 12 months or medically induced menopause in premenopausal women for AI therapy use\n* At least 5 years since other malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or adequately treated stage I or II cancer from which the patient is currently in complete remission\n* Ability to read and understand English, Spanish, or translations by interpreters for questionnaires\n* Histologically confirmed primary invasive adenocarcinoma of the breast or ductal carcinoma in situ of the breast\n\n  * Stage 0, I, II, or IIIA disease\n  * No metastatic disease\n* Must have undergone definitive breast cancer surgery and recovered\n* Must have completed adjuvant chemotherapy as applicable, including systemic chemotherapy, anti-HER2 therapy, and\u002For radiation therapy\n* Estrogen-receptor positive (ER+) and\u002For progesterone-receptor positive (PR+)\n* Currently taking a third-generation aromatase inhibitor (AI) (e.g., anastrozole \\[Arimidex (registered trademark)\\], letrozole \\[Femara (registered trademark)\\], or exemestane \\[Aromasin (registered trademark)\\]) for ≥ 90 days prior to registration with plans to continue for ≥ 180 days after registration\n* Must have a worst pain\u002Fstiffness of ≥ 4 on the Brief Pain Inventory (BPI) (item #2) that has started or increased with AI therapy\n\nExclusion Criteria:\n\n* \\\u003C 3 months since prior cannabinoid containing cannabis or hemp products including CBD, tetrahydrocannabinol (THC), Marinol, and Epidiolex and must agree to refrain from use from sources outside of this study\n* \\\u003C 28 days since prior investigational agents\n* Medical therapy, alternative therapy, or physical therapy for joint pain\u002Fstiffness within the past 30 days\n* Narcotic use within 14 days of registration\n* Patients may have received corticosteroid treatment; however, the following criteria apply:\n\n  * Patients must not have received oral or intramuscular corticosteroids within 28 days prior to registration\n  * Patients must not have received intra-articular steroids to the study, or any other, joint within 28 days prior to registration\n* Patients must not have received topical analgesics (e.g., capsaicin preparations) to the study joint or any other analgesics (e.g., opiates, tramadol; with exception of nonsteroidal anti-inflammatory drugs \\[NSAIDs\\] and acetaminophen) within 14 days prior to registration\n* History of bone fracture or surgery of the afflicted hands, knees, and\u002For other joints within 6 months prior to registration\n* Any uncontrolled illness including ongoing or active infection\n* Known allergies or contraindications to cannabis\n* Significantly impaired hepatic function (alanine aminotransferase \\[ALT\\] \\> 5 x upper limit of normal \\[ULN\\] or total bilirubin \\[TBL\\] \\> 2 x ULN) OR the ALT or aspartate aminotransferase (AST) \\> 3 x ULN and TBL \\> 2 x ULN (or international normalized ratio \\[INR\\] \\> 1.5\n* Grade 3+ renal impairment\n* Clinically significant lab abnormalities in ALT, AST, total bilirubin, hemoglobin, hematocrit, or creatinine or any other laboratory tests that in the opinion of the investigator would prevent the patient from safely participating in the study\n* Having current thoughts of suicide or self-harm or history of suicidal ideation or attempted suicide\n* Meeting Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria for current major psychiatric illness, such as bipolar disorder, major depression, or psychosis (including schizophrenia and affective psychosis)\n* History of seizure disorder\n* Concomitant administration with drugs that may interact adversely with CBD including warfarin, theophylline, amiodarone, anti-epileptic (e.g., clobazam, stiripentol, valproate, topiramate), anticonvulsant (e.g., diazepam, lamotrigine, phenytoin, ethosuximide, oxcarbazepine, pregabalin, tigabine, gabapentin); 3) barbiturate (e.g., phenobarbital, hexobarbital), benzodiazepine (e.g, chlordiazepoxide, clonazepam), opioid\u002Fnarcotic (e.g, codeine, morphine)\n* Concomitant administration of cyclin-dependent kinase 4\u002F6 inhibitors, such as abemaciclib, with AI therapy\n* Following a physical examination, the patient has any abnormalities that, in the opinion of the investigator would prevent the patient from safely participating in the study\n* Other active malignancy\n* Any other condition or medication use that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Participants unwilling to abstain from donation of blood during the study\n* Participants who plan to travel outside of the United States during the study period\n* Women with childbearing potential are not eligible to participate. The study is for postmenopausal women taking aromatase inhibitors for adjuvant endocrine therapy\n* Participants with cognitive impairment are excluded due to dose titration instructions and completion of questionnaires\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":157,"type":21},36,[24],"This phase II trial tests the effectiveness of cannabidiol (CBD) plant extract (BRC-001) in improving joint stiffness and pain (arthralgia) in women with breast cancer taking aromatase inhibitors (AIs). AIs lower blood levels of estrogen in postmenopausal women to reduce breast cancer recurrence. Women on AI therapy may experience joint stiffness, pain and arthritis symptoms as a side effect of the medication. Some women stop AI therapy due to these side effects and do not receive the maximum benefit from the medication. CBD is derived from the same plant family as marijuana but is not associated with a \"high\" or mind-altering effect and is not habit-forming. Research in animals and humans indicates that CBD might decrease inflammation in joint tissues and may help reduce chronic pain in ailments such as arthritis. BRC-001 may reduce joint pain in women with breast cancer taking AIs.",[161,162,163,164,165,30,32,166],"Anatomic Stage 0 Breast Cancer AJCC v8","Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage IIIA Breast Cancer AJCC v8","Breast Adenocarcinoma","Progesterone Receptor-Positive Breast Carcinoma","2026-04-27",{"date":169,"type":37},"2026-04-30",{"date":171,"type":37},"2024-08-26",{"date":173,"type":21},"2027-01-24",{"name":175,"class":76},"City of Hope Medical Center",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":198},"100373560","phase-1-a-vaccine-h2nvac-before-surgery-for-the-treatment-of-her2-expressing-ductal-carcinoma-in-situ-100373560","NCT04144023","A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ","A Phase IB Trial of Neoadjuvant Multi-Epitope HER2 Peptide Vaccine in Patients With HER2-Expressing DCIS","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Patients must not have received any prior therapy for current DCIS\n\n  * Note: Patients who received tamoxifen, raloxifene, aromatase inhibitor or another agent for prevention of breast cancer may be included as long as the patient has discontinued the treatment at least 2 months prior to baseline study biopsy if they chose to have this collected\n  * Note: Concurrent use of endocrine therapy during the vaccination\u002Fpreoperative period is not allowed. However, standard adjuvant endocrine therapy with tamoxifen or aromatase inhibitor after completion of vaccination and surgery is allowed\n* Any degree of HER2 expression as performed on the diagnostic clinical biopsy defined by immunohistochemistry +1, +2, or +3\n* Histologically confirmed un-resected operable ductal carcinoma in situ with no evidence of lymph node involvement or distant metastasis\n\n  * Note: suspected microinvasion or definite microinvasion (\\\u003C 0.1 mm invasion) on core biopsy is allowed\n* Patients will be asked to have an additional research biopsy prior to the first vaccination. This is not mandatory for participation\n* Patients must have evidence of at least 0.5 cm of disease extent based on mammogram, ultrasound, or magnetic resonance (MRI) imaging\n* Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3 (less than or equal to 28 days prior to registration)\n* Platelet count \\>= 75,000\u002Fmm\\^3 (less than or equal to 28 days prior to registration)\n* Hemoglobin \\>= 9.0 g\u002FdL (less than or equal to 28 days prior to registration)\n* Creatinine =\\\u003C 2 x upper limit of normal (ULN) (less than or equal to 28 days prior to registration)\n* Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \\[AST\\]) =\\\u003C 2 x ULN (less than or equal to 28 days prior to registration)\n* Albumin \\>= 3 g\u002FdL (less than or equal to 28 days prior to registration)\n* Negative serum pregnancy test done =\\\u003C 7 days prior to Registration, for women of childbearing potential only\n* Willing to employ adequate contraception from the time of Registration through 6 months after the final vaccine cycle\n\n  * Note: Adequate contraception methods include birth control pills, barrier device, intrauterine device, or abstinence\n* Capable of understanding the investigative nature, potential risks, and benefits of the study\n* Capable of providing valid informed consent\n* Willing to return to enrolling institution for all study visits (immunizations, blood draws, etc)\n* Willing to provide blood samples for correlative research purposes\n* Willing to receive a tetanus vaccination if subject has not had one within the past year\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:\n\n  * Pregnant women\n  * Nursing women unwilling to stop breast feeding\n  * Women of child bearing potential who are unwilling to employ adequate contraception from the time of registration through 6 months after the final vaccine cycle\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive or those on chronic steroids, unless physiologic replacement for adrenal or pituitary insufficiency\n\n  * Note: Must be off systemic steroids greater than or equal to 90 days prior to Registration. However, topical steroids, inhalants or steroid eye drops are permitted\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 requirements\n* Uncontrolled acute or chronic medical conditions including, but not limited to the following:\n\n  * Active infection requiring antibiotics\n  * Congestive heart failure with New York Heart Association class III or IV moderate to severe objective evidence of cardiovascular disease\n  * Myocardial infarction or stroke less than or equal to 6 months prior to registration\n* Receiving any other investigational agent\n* Other active malignancy at time of registration or less than or equal to the last three years prior to registration. EXCEPTIONS: Non-melanoma skin cancer or carcinoma-in-situ (e.g. of cervix, prostate)\n\n  * NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment (cytotoxics, monoclonal antibodies, small molecule inhibitors) for their cancer\n* Known history of active autoimmune disease that has required systemic treatment in the ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-registration\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded\n* Any prior hypersensitivity or adverse reaction to GM-CSF\n* History of trastuzumab-related cardiac toxicity requiring interruption or discontinuation of therapy, even if left ventricular ejection fraction (LVEF) fully recovered\n* Baseline LVEF with a value below 55%\n* Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment\n* History of myocardial infarction =\\\u003C 168 days (6 months) prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life threatening ventricular arrhythmias\n* History of ipsilateral radiation to the current affected breast with DCIS",{"count":184,"type":21},43,[186],"PHASE1","This phase Ib trial studies the side effects and best dose of a vaccine called H2NVAC before surgery in treating patients with HER2 expressing ductal carcinoma in situ. H2NVAC is a vaccine designed to stimulate specialized white blood cells in hopes of increasing immune response and protecting against breast cancer.",[30],"2026-03-03",{"date":191,"type":37},"2026-03-05",{"date":193,"type":37},"2019-06-27",{"date":195,"type":21},"2027-12-31",{"name":197,"class":76},"Mayo Clinic",2,{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":77},"100543025","a-patient-navigation-program-for-addressing-disparities-in-breast-cancer-care-100543025","NCT06350500","A Patient Navigation Program for Addressing Disparities in Breast Cancer Care","Addressing Disparities in Breast Cancer Care: An Approach to Health Equity","Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Have a confirmed diagnosis of breast cancer or Ductal Carcinoma In Situ (DCIS)\n* Currently identify their gender as woman or female\n* Was assigned female sex at birth (AFAB)\n\n  \\- Participant is experiencing ≥1 barrier to care as determined by the social needs screening tool\n* Participant must understand the investigational nature of this study and verbally consent to participate prior to receiving any study related intervention\n\nExclusion Criteria:\n\n* Participants who are not suspected of or diagnosed with breast cancer or Ductal Carcinoma in Situ (DCIS)\n* Participants who have had a previous diagnosis of any cancer\n* Participants who were assigned male sex or intersex at birth\n* Unwilling or unable to follow protocol requirements",{"count":207,"type":21},126,[56],"This clinical trial evaluates a patient navigation program for addressing disparities in breast cancer care. The navigation program is designed to help improve patient knowledge about clinical and supportive care services, navigate to existing services, help manage barriers to care, and enhance patient skills related to management of cancer treatment. Offering a patient navigation program may increase health equity and improve social needs and quality of life over time for newly diagnosed breast cancer patients.",[29,211],"Breast Ductal Carcinoma in Situ","2026-02-11",{"date":214,"type":37},"2026-02-17",{"date":216,"type":37},"2024-12-15",{"date":218,"type":21},"2028-03-15",{"name":220,"class":76},"Roswell Park Cancer Institute",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":228,"minAge":229,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":231,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":77},"100436149","pre-operative-sabr-with-and-without-caloric-restriction-for-early-stage-breast-cancer-100436149","NCT04959474","Pre-operative SABR With and Without Caloric Restriction for Early Stage Breast Cancer","SABR-CaRe: A Phase II Randomized Trial of Pre-Operative Stereotactic Ablative Radiation Therapy (SABR) With and Without Caloric Restriction for Early Stage Breast Cancer","Inclusion Criteria:\n\n* • Patients with pathologically proven DCIS or invasive breast cancer histologies\n* Willing and able to provide informed consent\n* Willing and able to comply with study treatments including dietary intervention\n* Body mass index (BMI) \\>= 21 at time of enrollment\n* Age \\>= 40 years at time of consent\n\n  \\* Patients with triple negative breast cancer (TNBC) must be \\>= 50 years of age at time of consent\n* Karnofsky performance status (KPS) score 70 - 100\n* Tumor size =\\\u003C 3.0 cm\n* Gross disease within the breast must be unifocal\n\n  \\* Gross disease may be multifocal as long as the total extent of tumor, gross and microscopic, occupies a volume with greatest dimension =\\\u003C 3 cm\n* Patients with invasive disease are required to have clinical axillary staging including axillary ultrasound (US) that proves patient is clinically node negative or can be done by physical examination if the patient is over 70\n* Patient is not being considered for preoperative chemotherapy\n* Must be English or Spanish speaking\n\nExclusion Criteria:\n\n* Patient is clinically node positive: clinically suspicious axillary lymph node(s) by axillary US or exam unless biopsied and found to be negative\n* Patient has stage IV metastatic disease\n\n  \\* Patients with oligo-metastatic disease who are being treated with curative intent per the treating physician will not be excluded if all other eligibility criteria are met\n* Breast tumor size is \\> 3.0 cm\n* Positive non-axillary sentinel nodes or evidence of suspicious supraclavicular, infraclavicular, or internal mammary nodes by imaging or physical exam, unless biopsied and found to be negative for tumor\n* Evidence by physical examination or mammography of other suspicious masses, densities, or microcalcifications in either breast, unless biopsied and found to be benign\n* Paget's disease of the nipple\n* Previous breast radiation on ipsilateral side\n* Any prior treatment with radiation therapy or chemotherapy for the current breast cancer diagnosis prior to registration\n* Patients with significant psychiatric illness that would preclude them from adhering to the protocol in the judgement of the treating clinician\n* BMI \\\u003C 21 at the time of study enrollment","ALL","40 Years",{"count":112,"type":21},[56],"This phase II trial studies the effect of calorie reduction while undergoing stereotactic ablative radiation therapy in treating patients with breast cancer. Stereotactic ablative radiation therapy (sABR) is a highly focused radiation treatment that gives an intense dose of radiation concentrated on a tumor, while limiting the dose to the surrounding organ. Giving SABR before surgery may make the tumor smaller. Adding dietary restrictions in combination with radiation therapy may help increase local control and decrease the spread of the cancer to other places in the body. The purpose of this trial is to identify if there is a decrease in tumor tissue in patients undergoing caloric restriction during pre-operative SABR, compared to patients undergoing pre-operative SABR alone.",[161,234,235,236,211,139,237],"Anatomic Stage 1 Breast Cancer AJCC v8","Anatomic Stage 2 Breast Cancer AJCC v8","Anatomic Stage 3 Breast Cancer AJCC v8","Triple Negative Breast Carcinoma","2026-01-21",{"date":240,"type":37},"2026-01-23",{"date":242,"type":37},"2021-08-23",{"date":244,"type":21},"2028-11-01",{"name":246,"class":76},"Thomas Jefferson University",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":85,"sex":228,"minAge":17,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":22,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":264,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":198},"100400493","identifying-and-caring-for-individuals-with-inherited-cancer-syndrome-100400493","NCT04494945","Identifying and Caring for Individuals With Inherited Cancer Syndrome","Approaches to Identify and Care for Individuals With Inherited Cancer Syndromes","Inclusion Criteria:\n\n* ALL COHORTS: 18 years of age or older\n* Retrospective COHORT A: Per HIPAA waiver, Retrospective Cohort A will not actively consent\n* Retrospective COHORT A: Patients may or may not be diagnosed with cancer\n* Retrospective COHORT A: Patients have received genetic counseling in the past 5 years\n* Retrospective COHORT A: Patients have genetic variants that include BRCA1, BRCA2 and\u002For Lynch syndrome\n* COHORT A: Per Health Insurance Portability and Accountability Act (HIPAA) waiver, Cohort A returns survey as consent\n* COHORT A: Patients may or may not be diagnosed with cancer\n* COHORT A: Patients have received genetic counseling in the past 1 - 2 years\n* COHORT A: Patients have genetic variants that include BRCA1, BRCA2 and\u002For Lynch syndrome\n* COHORT A: INCLUSIVE of no contact list to exclude from Cohort B\n* COHORT B: Creation of secure Healthy Oregon Project (HOP) app account\n* COHORT B: Consent to this project, either hard or electronic signature\n* COHORT B: Consent to the HOP repository, either hard or electronic signature\n* COHORT B: Choosing to submit a deoxyribonucleic acid (DNA) sample\n* COHORT B: Patients diagnosed with any National Cancer Institute (NCI)-reportable cancers, including ductal carcinoma in situ (DCIS) and\u002For in situ breast cancer\n* COHORT B: Must have had an encounter within past twelve months\n* COHORT B: Exclude Cohort A\n* COHORT C: Creation of secure Hop app account\n* COHORT C: Consent to this project, either hard or electronic signature\n* COHORT C: Consent to the HOP repository, either hard or electronic signature\n* COHORT C: Choosing to submit a DNA sample",{"count":255,"type":21},27500,[56],"This trial examines approaches to identify and care for individuals with inherited cancer syndrome. The purpose of this study is to offer no cost genetic testing to the general public. Researchers hope to learn the value of providing broad, public-wide testing for high risk cancer types (like hereditary breast and ovarian cancer or Lynch syndromes) instead of only testing people whose families are known to be high risk.",[259,30,260,261,262,263],"BRCA1\u002F2-Associated Hereditary Breast and Ovarian Cancer Syndrome","Hematopoietic and Lymphoid System Neoplasm","Hereditary Neoplastic Syndrome","Lynch Syndrome","Malignant Solid Neoplasm",{"date":240,"type":37},{"date":266,"type":37},"2020-03-09",{"date":268,"type":21},"2026-03-31",{"name":270,"class":76},"OHSU Knight Cancer Institute",{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":228,"minAge":17,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":22,"phases":280,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":77},"100464431","neoadjuvant-breast-cancer-time-restricted-eating-100464431","NCT05327608","Neoadjuvant Breast Cancer Time Restricted Eating","Time Restricted Eating for Patients With HER2- Negative Breast Cancer Receiving Neoadjuvant Chemotherapy","Inclusion Criterion\n\nIndividuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:\n\n1. Patient must be ≥ 18 years of age at time of consent and must be able to understand and provide informed consent.\n2. BMI 25-40 at time of enrollment.\n3. Patients must have an ECOG performance status of 0 or 1.\n4. Patient must have a recent diagnosis of histologically confirmed primary invasive breast carcinoma.\n\n   1. Multifocal or contralateral DCIS or invasive breast cancers are allowed if the breast cancers meet the same eligibility criteria for ER\u002FPR and HER2.\n   2. Oligometastatic disease is allowed if treating physician recommends standard neoadjuvant chemotherapy.\n5. Tumor status must be HER2 negative per ASCO\u002FCAP guidelines (determined by local testing).\n6. Patients must have clinical stage I-III (utilizing TNM criterion) at diagnosis.\n7. Clinical T size must be ≥ 1.5cm if there is no radiographic or clinical evidence of axillary lymph node involvement. Any size tumor is allowed if axillary lymph nodes appear to be involved.\n8. Patient must be willing and able (have no contraindication) to receive recommended standard neoadjuvant therapy consisting of at least 16 weeks of planned neoadjuvant chemotherapy.\n\n   a. Acceptable regimen includes doxorubicin and cytoxan followed by a taxane The schedule will be determined by treating physician. Carboplatin and pembrolizumab can also be added to the neoadjuvant chemotherapy regimen if determined to be appropriate by treating physician.\n9. Patients must have organ and marrow function adequate for initiating neoadjuvant chemotherapy as determined by their treating physician.\n10. Patient must be willing and able (have no contraindication) to participate in TRE consisting of 16 weeks\n11. Women of childbearing potential and sexually active males must use accepted and effective method(s) of contraception or abstain from sexual intercourse for the duration of their participation in the study and for 6 months after the last study intervention.\n12. Patient must have a personal email address, an internet-capable device, and the ability\u002F willingness to read and reply to email every day for the duration of the study.\n\nExclusion Criteria\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Clinical T4 and\u002For N3 disease, including inflammatory breast cancer.\n2. Any prior treatment for the current breast cancer diagnosis, including surgery, chemotherapy, radiation, or experimental therapy.\n3. Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. Patients must also not expect to conceive from the time of registration, while on study treatment, and until at least 6 months after the last study intervention.\n4. Patients with type 1 diabetes, or type 2 diabetes treated with insulin.\n5. Patients with a history of eating disorder or taking weight loss medications\n6. Patients who actively smoke\n7. Patients who work night shifts or on a rotating shift schedule.\n8. Patients must not have impaired decision-making capacity.\n9. Patients who are not English speaking as study staff is only able to provide the study intervention measurement tool.\n10. Patients that are \\>2 weeks into starting neoadjuvant chemotherapy regimen.",{"count":279,"type":21},55,[56],"A phase II study to evaluate an innovative approach of following time restricted eating (TRE) in patients with HER2- negative breast cancer who will start neoadjuvant chemotherapy (NCT) for a new diagnosis of stage I-III breast cancer. Participants at baseline will have a body mass index (BMI) of (25-40) and engage in a TRE 16:8 schedule which includes 16 hours of fasting and 8 hours of eating. Patients will continue TRE for 16 weeks while receiving NCT. For patients who report at the time of the 2-3 week clinic visit that they are finding it challenging to adhere to the 16:8 TRE, instructions will be provided about alternative measures such as changing the time of the day they fast, dietary modifications and finally changing to a 14:10 schedule if other measures fail. For patients requiring NCT for longer than 16 weeks, they will be encouraged to continue TRE. Adherence calculation for the primary endpoint will include data for the first 16 weeks, and then monitored separately for any additional optional fasting beyond the first 16 weeks. Adherence to TRE will be self-reported by patients daily through electronic surveys through RedCap and approximately every 2-3 weeks (+\u002F- 5 days) by the research team during their clinic visit.",[162,163,283,211,284,285,139],"Anatomic Stage III Breast Cancer AJCC v8","HER2 Negative Breast Carcinoma","Hormone Receptor Positive Breast Carcinoma","2025-07-30",{"date":288,"type":37},"2025-08-01",{"date":290,"type":37},"2022-07-28",{"date":292,"type":21},"2027-05-01",{"name":246,"class":76}]