[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521927":3},{"organization":4,"armGroups":7,"interventions":33,"overallOfficials":65,"centralContacts":73,"locations":84,"responsibleParty":500,"collaborators":39,"id":502,"slug":503,"hasResults":504,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":39,"eligibilityCriteria":508,"healthyVolunteers":504,"sex":509,"minAge":510,"maxAge":39,"enrollmentInfo":511,"targetDuration":39,"studyType":514,"phases":515,"briefSummary":517,"conditions":518,"keywords":520,"overallStatus":87,"whyStopped":39,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":533},{"fullName":5,"class":6},"QuantumLeap Healthcare Collaborative","OTHER",[8,17,23,28],{"label":9,"type":10,"description":11,"interventionNames":12},"chemoprevention therapy per investigator choice","ACTIVE_COMPARATOR","For premenopausal women: 20 mg tamoxifen orally daily (standard dose) or 10 mg every other day (low dose).\n\nFor postmenopausal women: standard oral doses of AI of choice: exemestane 25 mg daily, letrozole 2.5 mg daily, or anastrozole 1 mg daily; or reduced exemestane dosing: 25 mg 3X per week orally.\n\nFor postmenopausal women who are not tolerating an AI, investigators can change them to the low dose (10 mg every other day) or standard dose (20 mg) of tamoxifen.\n\nThere is active follow up with MRI at baseline, 3 months, 6 months after treatment initiation, and every 6 months alternating MRI and mammogram for up to 5 years. Participants may continue treatment for up to 5 years.",[13,14,15,16],"Drug: Tamoxifen","Drug: Exemestane","Drug: Letrozole","Drug: Anastrazole",{"label":18,"type":19,"description":20,"interventionNames":21},"Testosterone + Anastrazole (T+Ai)","EXPERIMENTAL","White solid pellet for subcutaneous insertion consisting of 100mg Testosterone and 4mg Anastrazole, an aromatase inhibitor. A cylindrical pellet (4.5mm diameter, 6.35mm diameter) is inserted subcutaneously in the upper outer gluteal region or iliac fossa every 3 months, with treatment up to 36 months. There is active follow up with MRI at baseline, 3 months, 6 months after treatment initiation, and every 6 months alternating MRI and mammogram for up to 5 years. Participants are followed for an additional 5 years.",[22],"Drug: Testosterone + Anastrazole",{"label":24,"type":19,"description":25,"interventionNames":26},"Elacestrant","Selective estrogen receptor degrader, Standard dose: 400mg PO with food once daily for treatment up to 36 months. Dose reduction of Elacestrant by up to 2 dose levels permitted depending on toxicity; 400 mg to 300 mg then 300 mg to 200 mg Participants requiring more than 2 dose reductions must discontinue treatment For patients on this arm there is active follow up with MRI at baseline, 3 months, 6 months after treatment initiation, and every 6 months alternating MRI and mammogram for up to 5 years. Participants are followed by for an additional 5 years.",[27],"Drug: Elacestrant",{"label":29,"type":19,"description":30,"interventionNames":31},"Endoxifen","(Z)-endoxifen is the most active metabolite of the selective estrogen receptor modulator (SERM), tamoxifen. Standard dose: 10mg PO delayed release capsule of z-endoxifen once daily for treatment up to 36 months. same time with a glass of water either 1 hour before a meal or 2 hours after a meal and should not take with alcohol. For patients on this arm there is active follow up with MRI at baseline, 3 months, 6 months after treatment initiation, and every 6 months alternating MRI and mammogram for up to 5 years. Participants are followed for an additional 5 years.",[32],"Drug: Z-endoxifen",[34,40,44,48,52,58,61],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"DRUG","Tamoxifen","For premenopausal women: 20 mg tamoxifen orally daily (standard dose) or 10 mg every other day (low dose).\n\nFor postmenopausal women who are not tolerating an AI, investigators can change them to the low dose (10 mg every other day) or standard dose (20 mg) of tamoxifen.",[9],null,{"type":35,"name":41,"description":42,"armGroupLabels":43,"otherNames":39},"Exemestane","For postmenopausal women: standard oral doses of AI of choice: exemestane 25 mg daily, or reduced exemestane dosing: 25 mg 3 times per week orally",[9],{"type":35,"name":45,"description":46,"armGroupLabels":47,"otherNames":39},"Letrozole","For postmenopausal women: standard oral doses of AI of choice: letrozole 2.5 mg daily.",[9],{"type":35,"name":49,"description":50,"armGroupLabels":51,"otherNames":39},"Anastrazole","For postmenopausal women: standard oral doses of AI of choice: anastrozole 1 mg daily.",[9],{"type":35,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"Testosterone + Anastrazole","Investigational drug. Both pre- and post- menopausal subjects. 100mg testosterone in combination with 4mg anastrazole administered subcutaneously every 3 months for up to 3 years.",[18],[57],"T+Ai",{"type":35,"name":24,"description":59,"armGroupLabels":60,"otherNames":39},"Investigational drug. Both pre- and post- menopausal subjects. Elacestrant 400mg PO with food once daily up to 36 months.",[24],{"type":35,"name":62,"description":63,"armGroupLabels":64,"otherNames":39},"Z-endoxifen","Investigational drug. Both pre- and post- menopausal subjects. (z)-endoxifen 10mg delayed release capsule 1 hour before a meal or 2 hours after a meal once daily for up to 36 months.",[29],[66,70],{"name":67,"affiliation":68,"role":69},"Laura Esserman, MD, MBA","University of California, San Fancisco - Department of Surgery","PRINCIPAL_INVESTIGATOR",{"name":71,"affiliation":72,"role":69},"(Co-PI) Kelly Hewitt, MD, FACS","Huntsman Cancer Institute at the University of Utah",[74,80],{"name":75,"role":76,"phone":77,"phoneExt":78,"email":79},"Kim Nelson, RN","CONTACT","+1 (888) 343-9922","343","k.nelson@qlhc.org",{"name":81,"role":76,"phone":82,"phoneExt":39,"email":83},"Tammy Neseth, MA, CCRP","+1 (507) 269-8060","t.neseth@qlhc.org",[85,110,126,138,154,165,177,193,210,230,246,263,283,292,306,319,337,353,362,371,380,397,416,427,436,445,466,483],{"facility":86,"status":87,"city":88,"state":89,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"Berkeley Outpatient Center","RECRUITING","Berkeley","California","94158","United States","US",{"type":94,"coordinates":95},"Point",[96,97],-122.27275,37.87159,{"lat":97,"lon":96},[100,104,108],{"name":101,"role":76,"phone":102,"phoneExt":39,"email":103},"Niloufar Abdollahi","415.476.3322","Niloufar.abdollahi@ucsf.edu",{"name":105,"role":76,"phone":106,"phoneExt":39,"email":107},"Dasha Peiris","415-533-0141","Dasha.Peiris@ucsf.edu",{"name":109,"role":69,"phone":39,"phoneExt":39,"email":39},"Jordan Jackson, MD",{"facility":111,"status":87,"city":112,"state":89,"zip":113,"country":91,"countryCode":92,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"City of Hope -Duarte Cancer Center","Duarte","91010",{"type":94,"coordinates":115},[116,117],-117.97729,34.13945,{"lat":117,"lon":116},[120,124],{"name":121,"role":76,"phone":122,"phoneExt":39,"email":123},"Mellissa Henry, RN, MSN, FNP-C","626-713-8895","mehenry@coh.org",{"name":125,"role":69,"phone":39,"phoneExt":39,"email":39},"Jennifer Tseng, MD",{"facility":127,"status":87,"city":128,"state":89,"zip":129,"country":91,"countryCode":92,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"City of Hope - Lennar Foundation Cancer Center","Irvine","92618",{"type":94,"coordinates":131},[132,133],-117.82311,33.66946,{"lat":133,"lon":132},[136,137],{"name":121,"role":76,"phone":122,"phoneExt":39,"email":123},{"name":125,"role":69,"phone":39,"phoneExt":39,"email":39},{"facility":139,"status":87,"city":140,"state":89,"zip":141,"country":91,"countryCode":92,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"UCLA","Los Angeles","90095",{"type":94,"coordinates":143},[144,145],-118.24368,34.05223,{"lat":145,"lon":144},[148,152],{"name":149,"role":76,"phone":150,"phoneExt":39,"email":151},"Sophia Quiroz, Clinical Research Coordinator","310-794-0130","SQuiroz@mednet.ucla.edu",{"name":153,"role":69,"phone":39,"phoneExt":39,"email":39},"Mediget Teshome, MD",{"facility":155,"status":87,"city":156,"state":89,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"UCSF","San Francisco",{"type":94,"coordinates":158},[159,160],-122.41942,37.77493,{"lat":160,"lon":159},[163,164],{"name":105,"role":76,"phone":106,"phoneExt":39,"email":107},{"name":109,"role":69,"phone":39,"phoneExt":39,"email":39},{"facility":166,"status":87,"city":167,"state":89,"zip":168,"country":91,"countryCode":92,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"City of Hope","South Pasadena","91030",{"type":94,"coordinates":170},[171,172],-118.15035,34.11612,{"lat":172,"lon":171},[175,176],{"name":121,"role":76,"phone":122,"phoneExt":39,"email":123},{"name":125,"role":69,"phone":39,"phoneExt":39,"email":39},{"facility":178,"status":87,"city":179,"state":89,"zip":180,"country":91,"countryCode":92,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"John Muir Health","Walnut Creek","94598",{"type":94,"coordinates":182},[183,184],-122.06496,37.90631,{"lat":184,"lon":183},[187,191],{"name":188,"role":76,"phone":189,"phoneExt":39,"email":190},"Jen Johnson, Clinical Research Coordinator","925-674-2580","Jen.Johnson@johnmuirhealth.com",{"name":192,"role":69,"phone":39,"phoneExt":39,"email":39},"Monica Eigelberger, MD",{"facility":194,"status":87,"city":195,"state":196,"zip":197,"country":91,"countryCode":92,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"Moffitt Cancer Center","Tampa","Florida","33612",{"type":94,"coordinates":199},[200,201],-82.45843,27.94752,{"lat":201,"lon":200},[204,208],{"name":205,"role":76,"phone":206,"phoneExt":39,"email":207},"Neveen Abdo, Clinical Research Coordinator","727-748-9345","Neveen.abdo@moffitt.org",{"name":209,"role":69,"phone":39,"phoneExt":39,"email":39},"Laura Kruper, MD",{"facility":211,"status":87,"city":212,"state":213,"zip":214,"country":91,"countryCode":92,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"Winship Cancer Institute, Emory University","Atlanta","Georgia","30322",{"type":94,"coordinates":216},[217,218],-84.38798,33.749,{"lat":218,"lon":217},[221,225,228],{"name":222,"role":76,"phone":223,"phoneExt":39,"email":224},"Winship Clinical Trials Office","1-404-778-1868","winshipcto@emory.edu",{"name":226,"role":76,"phone":39,"phoneExt":39,"email":227},"Trisha Burrello","trisha.n.burrello@emory.edu",{"name":229,"role":69,"phone":39,"phoneExt":39,"email":39},"Clara Farley, MD",{"facility":231,"status":87,"city":232,"state":233,"zip":234,"country":91,"countryCode":92,"cosmosGeoPoint":235,"geoPoint":239,"contacts":240},"University of Chicago Medical Center","Chicago","Illinois","60637",{"type":94,"coordinates":236},[237,238],-87.65005,41.85003,{"lat":238,"lon":237},[241,244],{"name":242,"role":76,"phone":39,"phoneExt":39,"email":243},"Vhenyse Encarnacion","vhenyse.encarnacion@bsd.uchicago.edu",{"name":245,"role":69,"phone":39,"phoneExt":39,"email":39},"Betty Fan, MD",{"facility":247,"status":87,"city":248,"state":249,"zip":250,"country":91,"countryCode":92,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"Maple Grove Cancer Center","Maple Grove","Minnesota","55369",{"type":94,"coordinates":252},[253,254],-93.45579,45.07246,{"lat":254,"lon":253},[257,261],{"name":258,"role":76,"phone":259,"phoneExt":39,"email":260},"Oncology Access Nurse","612-624-2620","ccinfo@umn.edu",{"name":262,"role":69,"phone":39,"phoneExt":39,"email":39},"Jane Hui, MD",{"facility":264,"status":87,"city":265,"state":249,"zip":266,"country":91,"countryCode":92,"cosmosGeoPoint":267,"geoPoint":271,"contacts":272},"Hennepin Healthcare -Minneapolis","Minneapolis","55404",{"type":94,"coordinates":268},[269,270],-93.26384,44.97997,{"lat":270,"lon":269},[273,277,281],{"name":274,"role":76,"phone":275,"phoneExt":39,"email":276},"Hannah Merrill","952-993-0996","hannah.merrill@parknicollet.com",{"name":278,"role":76,"phone":279,"phoneExt":39,"email":280},"Niki Hoese","952-993-1585","nicole.hoese@parknicollet.com",{"name":282,"role":69,"phone":39,"phoneExt":39,"email":39},"Satya Bommakanti, MD",{"facility":284,"status":87,"city":265,"state":249,"zip":285,"country":91,"countryCode":92,"cosmosGeoPoint":286,"geoPoint":288,"contacts":289},"University of Minnesota","55455",{"type":94,"coordinates":287},[269,270],{"lat":270,"lon":269},[290,291],{"name":258,"role":76,"phone":259,"phoneExt":39,"email":260},{"name":262,"role":69,"phone":39,"phoneExt":39,"email":39},{"facility":293,"status":87,"city":294,"state":249,"zip":295,"country":91,"countryCode":92,"cosmosGeoPoint":296,"geoPoint":300,"contacts":301},"Health Partners - Frauenshuh Cancer Center","Saint Louis Park","55426",{"type":94,"coordinates":297},[298,299],-93.34801,44.9483,{"lat":299,"lon":298},[302,303,304],{"name":274,"role":76,"phone":275,"phoneExt":39,"email":276},{"name":278,"role":76,"phone":279,"phoneExt":39,"email":280},{"name":305,"role":69,"phone":39,"phoneExt":39,"email":39},"Rachel Lerner, MD",{"facility":307,"status":87,"city":308,"state":249,"zip":309,"country":91,"countryCode":92,"cosmosGeoPoint":310,"geoPoint":314,"contacts":315},"Health Partners - Regions Hospital","Saint Paul","55101",{"type":94,"coordinates":311},[312,313],-93.09327,44.94441,{"lat":313,"lon":312},[316,317,318],{"name":274,"role":76,"phone":275,"phoneExt":39,"email":276},{"name":278,"role":76,"phone":279,"phoneExt":39,"email":280},{"name":305,"role":69,"phone":39,"phoneExt":39,"email":39},{"facility":320,"status":87,"city":321,"state":322,"zip":323,"country":91,"countryCode":92,"cosmosGeoPoint":324,"geoPoint":328,"contacts":329},"Englewood Hospital and Medical Center","Englewood","New Jersey","07631",{"type":94,"coordinates":325},[326,327],-73.97264,40.89288,{"lat":327,"lon":326},[330,335],{"name":331,"role":76,"phone":332,"phoneExt":333,"email":334},"Kayla Williams","201-894-3000","9786","kayla.williams@ehmchealth.org",{"name":336,"role":69,"phone":39,"phoneExt":39,"email":39},"Jennifer Marti, MD",{"facility":338,"status":87,"city":339,"state":339,"zip":340,"country":91,"countryCode":92,"cosmosGeoPoint":341,"geoPoint":345,"contacts":346},"Mount Sinai Union Square","New York","10003",{"type":94,"coordinates":342},[343,344],-74.00597,40.71427,{"lat":344,"lon":343},[347,351],{"name":348,"role":76,"phone":349,"phoneExt":39,"email":350},"Contact: Site Public Contact","212-824-7309","CRSU@mssm.edu",{"name":352,"role":69,"phone":39,"phoneExt":39,"email":39},"Tara Balija, MD",{"facility":354,"status":87,"city":339,"state":339,"zip":355,"country":91,"countryCode":92,"cosmosGeoPoint":356,"geoPoint":358,"contacts":359},"Mount Sinai Chelsea","10011",{"type":94,"coordinates":357},[343,344],{"lat":344,"lon":343},[360,361],{"name":348,"role":76,"phone":349,"phoneExt":39,"email":350},{"name":352,"role":69,"phone":39,"phoneExt":39,"email":39},{"facility":363,"status":87,"city":339,"state":339,"zip":364,"country":91,"countryCode":92,"cosmosGeoPoint":365,"geoPoint":367,"contacts":368},"Mount Sinai West","10019",{"type":94,"coordinates":366},[343,344],{"lat":344,"lon":343},[369,370],{"name":348,"role":76,"phone":349,"phoneExt":39,"email":350},{"name":352,"role":69,"phone":39,"phoneExt":39,"email":39},{"facility":372,"status":87,"city":339,"state":339,"zip":373,"country":91,"countryCode":92,"cosmosGeoPoint":374,"geoPoint":376,"contacts":377},"Icahn School of Medicine at Mount Sinai","10029",{"type":94,"coordinates":375},[343,344],{"lat":344,"lon":343},[378,379],{"name":348,"role":76,"phone":349,"phoneExt":39,"email":350},{"name":352,"role":69,"phone":39,"phoneExt":39,"email":39},{"facility":381,"status":87,"city":382,"state":383,"zip":384,"country":91,"countryCode":92,"cosmosGeoPoint":385,"geoPoint":389,"contacts":390},"Duke Cancer Institute","Durham","North Carolina","27710",{"type":94,"coordinates":386},[387,388],-78.89862,35.99403,{"lat":388,"lon":387},[391,395],{"name":392,"role":76,"phone":393,"phoneExt":39,"email":394},"Breast Cancer Study Team","919-660-1278","breastcl@dm.duke.edu",{"name":396,"role":69,"phone":39,"phoneExt":39,"email":39},"Ton Wang, MD",{"facility":398,"status":87,"city":399,"state":383,"zip":400,"country":91,"countryCode":92,"cosmosGeoPoint":401,"geoPoint":405,"contacts":406},"Atrium Health Wake Forest Baptist Comprehensive Cancer Center","Winston-Salem","27157",{"type":94,"coordinates":402},[403,404],-80.24422,36.09986,{"lat":404,"lon":403},[407,411,414],{"name":408,"role":76,"phone":409,"phoneExt":39,"email":410},"Brandy Baker and Lindsy Davis, RN","336-716-8941 OR 336-716-6748","brandy.baker@advocatehealth.org, lindsey.davis@advocatehealth.org",{"name":412,"role":76,"phone":39,"phoneExt":39,"email":413},"Sydney McEntire","sydney.mcentire@advocatehealth.org",{"name":415,"role":69,"phone":39,"phoneExt":39,"email":39},"Marissa Howard-McNatt, MD",{"facility":417,"status":418,"city":419,"state":420,"zip":421,"country":91,"countryCode":92,"cosmosGeoPoint":422,"geoPoint":426,"contacts":39},"Bryn Mawr Hospital","ACTIVE_NOT_RECRUITING","Bryn Mawr","Pennsylvania","19010",{"type":94,"coordinates":423},[424,425],-80.08672,40.30396,{"lat":425,"lon":424},{"facility":428,"status":418,"city":429,"state":420,"zip":430,"country":91,"countryCode":92,"cosmosGeoPoint":431,"geoPoint":435,"contacts":39},"Paoli Hospital","Paoli","19301",{"type":94,"coordinates":432},[433,434],-75.47631,40.04205,{"lat":434,"lon":433},{"facility":437,"status":418,"city":438,"state":420,"zip":439,"country":91,"countryCode":92,"cosmosGeoPoint":440,"geoPoint":444,"contacts":39},"Lankenau Medical Center","Wynnewood","19096",{"type":94,"coordinates":441},[442,443],-75.27074,40.00289,{"lat":443,"lon":442},{"facility":446,"status":87,"city":447,"state":448,"zip":449,"country":91,"countryCode":92,"cosmosGeoPoint":450,"geoPoint":454,"contacts":455},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"type":94,"coordinates":451},[452,453],-86.78444,36.16589,{"lat":453,"lon":452},[456,460,464],{"name":457,"role":76,"phone":458,"phoneExt":39,"email":459},"Oncology nursing","1-800-811-8480","cip@vumc.org",{"name":461,"role":76,"phone":462,"phoneExt":39,"email":463},"Jennifer Goodman, RN, BSN","615.936.6825","jennifer.e.goodman@vumc.org",{"name":465,"role":69,"phone":39,"phoneExt":39,"email":39},"Ingrid Meszoely, MD",{"facility":467,"status":87,"city":468,"state":469,"zip":470,"country":91,"countryCode":92,"cosmosGeoPoint":471,"geoPoint":475,"contacts":476},"Huntsman Cancer Institute","Salt Lake City","Utah","84112",{"type":94,"coordinates":472},[473,474],-111.89105,40.76078,{"lat":474,"lon":473},[477,481],{"name":478,"role":76,"phone":479,"phoneExt":39,"email":480},"Janna Espinosa","801-585-0571","Janna.Espinosa@hci.utah.edu",{"name":482,"role":69,"phone":39,"phoneExt":39,"email":39},"Kirstyn Brownson, MD",{"facility":484,"status":87,"city":485,"state":486,"zip":487,"country":91,"countryCode":92,"cosmosGeoPoint":488,"geoPoint":492,"contacts":493},"Virginia Commonwealth University","Richmond","Virginia","23298",{"type":94,"coordinates":489},[490,491],-77.46026,37.55376,{"lat":491,"lon":490},[494,498],{"name":495,"role":76,"phone":496,"phoneExt":39,"email":497},"Massey CTO Breast Team","804-628-6430","masseyctbrst@vcu.edu",{"name":499,"role":69,"phone":39,"phoneExt":39,"email":39},"Kandace McGuire, MD",{"type":501,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100521927","phase-2-dcis-recast-trial-ductal-carcinoma-in-situ-re-evaluating-conditions-for-active-surveillance-suitability-as-treatment-100521927",false,"NCT06075953","DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment","DCIS: RECAST Trial -Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: a Breast Cancer Prevention Pilot Study","Inclusion Criteria:\n\nA. Female, at least 18 years old\n\nB. Previous diagnosis of HR+ DCIS (at least 50% ER or PR; biopsy will have been performed previously at diagnosis) with or without microinvasion\n\n* Patients with a diagnosis of hormone positive DCIS who have undergone surgery with positive margins that have not been re-excised are candidates to enroll in the trial.\n\nC. Patients who have previously received endocrine therapy should have a washout period of at minimum 4-6 weeks prior to the screening MRI on the RECAST-DCIS trial\n\nD. Bilateral mammogram performed within up to 6 months (180 days) of the start of trial treatment may be used for screening evaluation. If a bilateral mammogram has been performed within 1 year (12 months) of the start of trial treatment, then a diagnostic unilateral mammogram within 6 months (180 days) of the start of trial treatment will be acceptable for screening evaluation.\n\nE. MRI performed on an I SPY (RECAST) approved scanner within 2 months (60 days) of the start of trial treatment for lesion evaluation may be used for screening evaluation.\n\nF. CBC w\u002F diff, CMP, and Lipid Panel within normal limits within a year of the start of trial treatment. Abnormal labs to be repeated within 60 days prior to the start of trial treatment. Patients will be considered eligible for screening labs that are abnormal or out-of-range if the investigator has deemed the lab results not-clinically significant\n\nG. Negative urine or serum pregnancy test within 1 month of the start of trial treatment\n\nH. Controlled HIV positive patients are allowed as long as their current medication does not contraindicate the study's investigational agent\n\nI. Willingness and ability to provide tumor samples for research\n\nExclusion Criteria:\n\nA. Pregnant or actively breastfeeding women\n\nB. History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent based on review of the medical record and patient history\n\nC. Invasive carcinoma or identification of a mass on MRI that is subsequently biopsied and found to be invasive cancer\n\nD. Co-enrollment in clinical trials of pharmacologic agents requiring an IND\n\nE. Ongoing treatment for DCIS other than what is specified in this protocol\n\nF. Uncontrolled intercurrent illness, including psychiatric conditions, that would limit compliance with study requirements\n\nG. Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of investigational agent and\u002For tamoxifen. Active inflammatory bowel disease or chronic diarrhea, known active hepatitis A\u002FB\u002FC\\*, hepatic cirrhosis, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection or banding procedures\n\n\\*Active hepatitis, defined as: A (positive HA antigen or positive IgM); B (either positive HBs antigen or positive hepatitis B viral DNA test above the lower limit of detection of the assay); C (positive hepatitis C antibody result, and quantitative hepatitis C (HCV) ribonucleic acid (RNA) results greater than the lower limits of detection of the assay)\n\nH. Participants who are unable to swallow normally or unable to take tablets and capsules. Predictable poor compliance with oral treatment","FEMALE","18 Years",{"count":512,"type":513},400,"ESTIMATED","INTERVENTIONAL",[516],"PHASE2","The goal of this trial is to see if active surveillance monitoring and hormonal therapy in patients diagnosed with ductal cell carcinoma in situ (DCIS), an early stage of breast cancer, can be an effective management of the disease.\n\nParticipants will be asked to receive control hormonal therapy or an investigational hormonal therapy treatment. Participants will be asked to return for evaluation with MRI at three months and six months. Depending on the evaluation participants will have the option to continue on the treatment. If the evaluation suggests surgery is recommended, the participant will discontinue the study treatment and will undergo surgery. In addition to the treatment and MRI evaluation, participants will be asked to provide blood sample to understand their immune status, provide saliva sample for genetic testing, provide the study with a portion of the tissue or slides generated from tissue removed during surgery performed as part of their standard of care.",[519],"Ductal Carcinoma in Situ",[521,522,523],"active surveillance","hormone therapy","endocrine therapy","2026-05-19",{"date":526,"type":527},"2026-05-22","ACTUAL",{"date":529,"type":527},"2024-02-17",{"date":531,"type":513},"2033-11",{"name":5,"class":6},28]