[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609434":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":547,"collaborators":20,"id":549,"slug":550,"hasResults":551,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":551,"sex":557,"minAge":558,"maxAge":20,"enrollmentInfo":559,"targetDuration":20,"studyType":562,"phases":563,"briefSummary":565,"conditions":566,"keywords":570,"overallStatus":145,"whyStopped":20,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":597},{"fullName":5,"class":6},"Natera, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ctDNA-Guided Therapy","EXPERIMENTAL","All participants receive circulating tumor DNA (ctDNA) testing using Signatera Genome every 3 months to guide treatment decisions. Participants with positive ctDNA results initiate CDK4\u002F6 inhibitor therapy (ribociclib or abemaciclib) in addition to standard endocrine therapy. Participants with negative ctDNA results continue endocrine therapy alone with ongoing ctDNA surveillance. All participants continue their assigned treatment pathway until disease progression, unacceptable toxicity, or study completion.",[13],"Device: ctDNA-Guided Treatment Strategy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","ctDNA-Guided Treatment Strategy","Circulating tumor DNA testing using Signatera Genome assay is performed every 3 months for up to 4 years to guide timing of CDK4\u002F6 inhibitor initiation. Participants with positive ctDNA results initiate CDK4\u002F6 inhibitor therapy (ribociclib or abemaciclib) plus standard endocrine therapy for a minimum of 2 years. Participants with negative ctDNA results continue endocrine therapy alone with ongoing surveillance. CDK4\u002F6 inhibitor selection and endocrine therapy regimen per the physician's choice following standard-of-care guidelines.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Angel Rodriguez, MD","STUDY_DIRECTOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Kayla Gelow, MS","CONTACT","844-778-4700","kgelow@natera.com",{"name":32,"role":28,"phone":29,"phoneExt":20,"email":33},"Jessica Reyes, BS","jguilford@natera.com",[35,53,66,82,94,107,119,131,143,159,171,184,196,211,220,232,244,256,271,287,300,315,329,341,354,367,376,389,403,418,431,444,457,472,484,497,510,522,534],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University of Alabama at Birmingham","NOT_YET_RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-86.80249,33.52066,{"lat":47,"lon":46},[50],{"name":51,"role":52,"phone":20,"phoneExt":20,"email":20},"Nusrat Jahan, MD","PRINCIPAL_INVESTIGATOR",{"facility":54,"status":37,"city":55,"state":56,"zip":57,"country":41,"countryCode":42,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Mayo Clinic Arizona","Phoenix","Arizona","85054",{"type":44,"coordinates":59},[60,61],-112.07404,33.44838,{"lat":61,"lon":60},[64],{"name":65,"role":52,"phone":20,"phoneExt":20,"email":20},"Shakeela Bahadur, MD",{"facility":67,"status":37,"city":68,"state":56,"zip":69,"country":41,"countryCode":42,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Honor Health Research Institute","Scottsdale","85258",{"type":44,"coordinates":71},[72,73],-111.89903,33.50921,{"lat":73,"lon":72},[76,78,80],{"name":77,"role":28,"phone":20,"phoneExt":20,"email":20},"Nathan Solod",{"name":79,"role":52,"phone":20,"phoneExt":20,"email":20},"Abhimanyu Ghose, MD",{"name":81,"role":52,"phone":20,"phoneExt":20,"email":20},"Wishwdeep Dhillon, MD",{"facility":83,"status":37,"city":84,"state":56,"zip":85,"country":41,"countryCode":42,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"University of Arizona Cancer Center","Tucson","85719",{"type":44,"coordinates":87},[88,89],-110.92648,32.22174,{"lat":89,"lon":88},[92],{"name":93,"role":52,"phone":20,"phoneExt":20,"email":20},"Sima Ehsani, MD",{"facility":95,"status":37,"city":96,"state":97,"zip":98,"country":41,"countryCode":42,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Adventist Health\u002FAIS Cancer Center","Bakersfield","California","93301",{"type":44,"coordinates":100},[101,102],-119.01871,35.37329,{"lat":102,"lon":101},[105],{"name":106,"role":52,"phone":20,"phoneExt":20,"email":20},"Madiha Naseem, MD",{"facility":108,"status":37,"city":109,"state":97,"zip":110,"country":41,"countryCode":42,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Marin Cancer Care","Greenbrae","94904",{"type":44,"coordinates":112},[113,114],-122.5247,37.94854,{"lat":114,"lon":113},[117],{"name":118,"role":52,"phone":20,"phoneExt":20,"email":20},"Cyrus Mazidi, MD",{"facility":120,"status":37,"city":121,"state":97,"zip":122,"country":41,"countryCode":42,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Loma Linda University","Loma Linda","92354",{"type":44,"coordinates":124},[125,126],-117.26115,34.04835,{"lat":126,"lon":125},[129],{"name":130,"role":52,"phone":20,"phoneExt":20,"email":20},"Gayathri Nagaraj, MD",{"facility":132,"status":37,"city":133,"state":97,"zip":134,"country":41,"countryCode":42,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"UCLA David Geffen School of Medicine","Santa Monica","90404",{"type":44,"coordinates":136},[137,138],-118.49138,34.01949,{"lat":138,"lon":137},[141],{"name":142,"role":52,"phone":20,"phoneExt":20,"email":20},"Marla Lipsyc-Sharf, MD",{"facility":144,"status":145,"city":146,"state":97,"zip":147,"country":41,"countryCode":42,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Stockton Hematology Oncology Medical Group","RECRUITING","Stockton","95204",{"type":44,"coordinates":149},[150,151],-121.29078,37.9577,{"lat":151,"lon":150},[154,157],{"name":155,"role":28,"phone":20,"phoneExt":20,"email":156},"Lenzi Cook","lcook@shomg.net",{"name":158,"role":52,"phone":20,"phoneExt":20,"email":20},"Ajithkumar Puthillath, MD",{"facility":160,"status":37,"city":161,"state":97,"zip":162,"country":41,"countryCode":42,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Kaiser Permanente NorCal","Vallejo","94589",{"type":44,"coordinates":164},[165,166],-122.25664,38.10409,{"lat":166,"lon":165},[169],{"name":170,"role":52,"phone":20,"phoneExt":20,"email":20},"Jennifer Suga, MD",{"facility":172,"status":37,"city":173,"state":174,"zip":175,"country":41,"countryCode":42,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Hartford Healthcare Institute","Hartford","Connecticut","06102",{"type":44,"coordinates":177},[178,179],-72.68509,41.76371,{"lat":179,"lon":178},[182],{"name":183,"role":52,"phone":20,"phoneExt":20,"email":20},"Richard Zelkowitz, MD",{"facility":185,"status":37,"city":186,"state":174,"zip":187,"country":41,"countryCode":42,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Yale Cancer Center","New Haven","06520",{"type":44,"coordinates":189},[190,191],-72.92816,41.30815,{"lat":191,"lon":190},[194],{"name":195,"role":52,"phone":20,"phoneExt":20,"email":20},"Lajos Pusztai, MD",{"facility":197,"status":37,"city":198,"state":199,"zip":200,"country":41,"countryCode":42,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Baptist MD Anderson","Jacksonville","Florida","32207",{"type":44,"coordinates":202},[203,204],-81.65565,30.33218,{"lat":204,"lon":203},[207,209],{"name":208,"role":28,"phone":20,"phoneExt":20,"email":20},"Vanessa Tolsa",{"name":210,"role":52,"phone":20,"phoneExt":20,"email":20},"Dayra Avila-Lima, MD",{"facility":212,"status":37,"city":198,"state":199,"zip":213,"country":41,"countryCode":42,"cosmosGeoPoint":214,"geoPoint":216,"contacts":217},"Mayo Clinic Florida","32224",{"type":44,"coordinates":215},[203,204],{"lat":204,"lon":203},[218],{"name":219,"role":52,"phone":20,"phoneExt":20,"email":20},"Pooja Advani, MD",{"facility":221,"status":37,"city":222,"state":199,"zip":223,"country":41,"countryCode":42,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"Jupiter Medical Cancer","Jupiter","33458",{"type":44,"coordinates":225},[226,227],-80.09421,26.93422,{"lat":227,"lon":226},[230],{"name":231,"role":52,"phone":20,"phoneExt":20,"email":20},"Danielle Krol, MD",{"facility":233,"status":37,"city":234,"state":199,"zip":235,"country":41,"countryCode":42,"cosmosGeoPoint":236,"geoPoint":240,"contacts":241},"Miami Cancer Institute","Miami","33176",{"type":44,"coordinates":237},[238,239],-80.19366,25.77427,{"lat":239,"lon":238},[242],{"name":243,"role":52,"phone":20,"phoneExt":20,"email":20},"Reshma Mahtani, DO",{"facility":245,"status":37,"city":246,"state":199,"zip":247,"country":41,"countryCode":42,"cosmosGeoPoint":248,"geoPoint":252,"contacts":253},"Ocala Oncology","Ocala","34474",{"type":44,"coordinates":249},[250,251],-82.14009,29.1872,{"lat":251,"lon":250},[254],{"name":255,"role":52,"phone":20,"phoneExt":20,"email":20},"Rama Balaraman, MD",{"facility":257,"status":37,"city":258,"state":259,"zip":260,"country":41,"countryCode":42,"cosmosGeoPoint":261,"geoPoint":265,"contacts":266},"Northwestern University","Chicago","Illinois","60611",{"type":44,"coordinates":262},[263,264],-87.65005,41.85003,{"lat":264,"lon":263},[267,269],{"name":268,"role":28,"phone":20,"phoneExt":20,"email":20},"Nicole Grzywacz",{"name":270,"role":52,"phone":20,"phoneExt":20,"email":20},"William Gradishar, MD",{"facility":272,"status":145,"city":273,"state":274,"zip":275,"country":41,"countryCode":42,"cosmosGeoPoint":276,"geoPoint":280,"contacts":281},"Northwest Cancer Center","Dyer","Indiana","46311",{"type":44,"coordinates":277},[278,279],-87.52171,41.4942,{"lat":279,"lon":278},[282,285],{"name":283,"role":28,"phone":20,"phoneExt":20,"email":284},"Mariela Abad","Mariela.Abad@usoncology.com",{"name":286,"role":52,"phone":20,"phoneExt":20,"email":20},"Shruti Singh, MD",{"facility":288,"status":37,"city":289,"state":290,"zip":291,"country":41,"countryCode":42,"cosmosGeoPoint":292,"geoPoint":296,"contacts":297},"New England Cancer Specialists","Westbrook","Maine","04092",{"type":44,"coordinates":293},[294,295],-70.37116,43.67703,{"lat":295,"lon":294},[298],{"name":299,"role":52,"phone":20,"phoneExt":20,"email":20},"Chiara Battelli, MD",{"facility":301,"status":37,"city":302,"state":303,"zip":304,"country":41,"countryCode":42,"cosmosGeoPoint":305,"geoPoint":309,"contacts":310},"Karmanos Cancer Center - Wayne State University","Detroit","Michigan","48201",{"type":44,"coordinates":306},[307,308],-83.04575,42.33143,{"lat":308,"lon":307},[311,313],{"name":312,"role":28,"phone":20,"phoneExt":20,"email":20},"Allison Wolgast",{"name":314,"role":52,"phone":20,"phoneExt":20,"email":20},"Jailan Elayoubi",{"facility":316,"status":37,"city":317,"state":303,"zip":318,"country":41,"countryCode":42,"cosmosGeoPoint":319,"geoPoint":323,"contacts":324},"Cancer & Hematology Centers","Grand Rapids","49504",{"type":44,"coordinates":320},[321,322],-85.66809,42.96336,{"lat":322,"lon":321},[325,327],{"name":326,"role":28,"phone":20,"phoneExt":20,"email":20},"Jared Hogeterp",{"name":328,"role":52,"phone":20,"phoneExt":20,"email":20},"Haritha Reddy",{"facility":330,"status":37,"city":331,"state":303,"zip":332,"country":41,"countryCode":42,"cosmosGeoPoint":333,"geoPoint":337,"contacts":338},"Munson Medical Center Cowell Family Cancer Center","Traverse City","49684",{"type":44,"coordinates":334},[335,336],-85.62063,44.76306,{"lat":336,"lon":335},[339],{"name":340,"role":52,"phone":20,"phoneExt":20,"email":20},"Yelena Kier, DO",{"facility":342,"status":37,"city":343,"state":344,"zip":345,"country":41,"countryCode":42,"cosmosGeoPoint":346,"geoPoint":350,"contacts":351},"Mayo Clinic","Rochester","Minnesota","55905",{"type":44,"coordinates":347},[348,349],-92.4699,44.02163,{"lat":349,"lon":348},[352],{"name":353,"role":52,"phone":20,"phoneExt":20,"email":20},"Karthik Giridhar, MD",{"facility":355,"status":37,"city":356,"state":357,"zip":358,"country":41,"countryCode":42,"cosmosGeoPoint":359,"geoPoint":363,"contacts":364},"Mercy Health - Sindelar Cancer Center","St Louis","Missouri","63128",{"type":44,"coordinates":360},[361,362],-90.19789,38.62727,{"lat":362,"lon":361},[365],{"name":366,"role":52,"phone":20,"phoneExt":20,"email":20},"Yifan Tu, MD",{"facility":368,"status":37,"city":356,"state":357,"zip":369,"country":41,"countryCode":42,"cosmosGeoPoint":370,"geoPoint":372,"contacts":373},"Mercy Health - Pratt Cancer Center","63141",{"type":44,"coordinates":371},[361,362],{"lat":362,"lon":361},[374],{"name":375,"role":52,"phone":20,"phoneExt":20,"email":20},"Bethany Sleckman, MD",{"facility":377,"status":37,"city":378,"state":379,"zip":380,"country":41,"countryCode":42,"cosmosGeoPoint":381,"geoPoint":385,"contacts":386},"Cooper Health","Camden","New Jersey","08103",{"type":44,"coordinates":382},[383,384],-75.11962,39.92595,{"lat":384,"lon":383},[387],{"name":388,"role":52,"phone":20,"phoneExt":20,"email":20},"Kamel Abou-Hussein, MD",{"facility":390,"status":37,"city":391,"state":379,"zip":392,"country":41,"countryCode":42,"cosmosGeoPoint":393,"geoPoint":397,"contacts":398},"Rutgers","New Brunswick","08901",{"type":44,"coordinates":394},[395,396],-74.45182,40.48622,{"lat":396,"lon":395},[399,401],{"name":400,"role":28,"phone":20,"phoneExt":20,"email":20},"Stephanie Farias",{"name":402,"role":52,"phone":20,"phoneExt":20,"email":20},"Mridula George, MD",{"facility":404,"status":37,"city":405,"state":406,"zip":407,"country":41,"countryCode":42,"cosmosGeoPoint":408,"geoPoint":412,"contacts":413},"New York Cancer and Blood Specialists","Babylon","New York","11702",{"type":44,"coordinates":409},[410,411],-73.32568,40.69566,{"lat":411,"lon":410},[414,416],{"name":415,"role":28,"phone":20,"phoneExt":20,"email":20},"Ivanna Novoa",{"name":417,"role":52,"phone":20,"phoneExt":20,"email":20},"Richard Zuniga",{"facility":419,"status":37,"city":420,"state":421,"zip":422,"country":41,"countryCode":42,"cosmosGeoPoint":423,"geoPoint":427,"contacts":428},"Atrium Levine Cancer Institute","Charlotte","North Carolina","28204",{"type":44,"coordinates":424},[425,426],-80.84313,35.22709,{"lat":426,"lon":425},[429],{"name":430,"role":52,"phone":20,"phoneExt":20,"email":20},"Arielle Heeke, MD",{"facility":432,"status":37,"city":433,"state":434,"zip":435,"country":41,"countryCode":42,"cosmosGeoPoint":436,"geoPoint":440,"contacts":441},"Allegheny (AHN)","Pittsburgh","Pennsylvania","15212",{"type":44,"coordinates":437},[438,439],-79.99589,40.44062,{"lat":439,"lon":438},[442],{"name":443,"role":52,"phone":20,"phoneExt":20,"email":20},"Joseph Liput, MD",{"facility":445,"status":37,"city":446,"state":447,"zip":448,"country":41,"countryCode":42,"cosmosGeoPoint":449,"geoPoint":453,"contacts":454},"Sanford Health","Sioux Falls","South Dakota","57104",{"type":44,"coordinates":450},[451,452],-96.72796,43.54369,{"lat":452,"lon":451},[455],{"name":456,"role":52,"phone":20,"phoneExt":20,"email":20},"Allison Watson, MD",{"facility":458,"status":37,"city":459,"state":460,"zip":461,"country":41,"countryCode":42,"cosmosGeoPoint":462,"geoPoint":466,"contacts":467},"West Cancer Center","Germantown","Tennessee","38138",{"type":44,"coordinates":463},[464,465],-89.81009,35.08676,{"lat":465,"lon":464},[468,470],{"name":469,"role":28,"phone":20,"phoneExt":20,"email":20},"Karen Axley",{"name":471,"role":52,"phone":20,"phoneExt":20,"email":20},"Gary Tian, MD",{"facility":473,"status":37,"city":474,"state":460,"zip":475,"country":41,"countryCode":42,"cosmosGeoPoint":476,"geoPoint":480,"contacts":481},"Vanderbilt","Nashville","37232",{"type":44,"coordinates":477},[478,479],-86.78444,36.16589,{"lat":479,"lon":478},[482],{"name":483,"role":52,"phone":20,"phoneExt":20,"email":20},"Brent Rexer, MD",{"facility":485,"status":37,"city":486,"state":487,"zip":488,"country":41,"countryCode":42,"cosmosGeoPoint":489,"geoPoint":493,"contacts":494},"Houston Methodist Hospital","Houston","Texas","77030",{"type":44,"coordinates":490},[491,492],-95.36327,29.76328,{"lat":492,"lon":491},[495],{"name":496,"role":52,"phone":20,"phoneExt":20,"email":20},"Akshjot Puri, MD",{"facility":498,"status":37,"city":499,"state":500,"zip":501,"country":41,"countryCode":42,"cosmosGeoPoint":502,"geoPoint":506,"contacts":507},"Northwest Medical Specialties, PLLC","Puyallup","Washington","98373",{"type":44,"coordinates":503},[504,505],-122.2929,47.18538,{"lat":505,"lon":504},[508],{"name":509,"role":52,"phone":20,"phoneExt":20,"email":20},"Sibel Blau, MD",{"facility":511,"status":37,"city":512,"state":500,"zip":513,"country":41,"countryCode":42,"cosmosGeoPoint":514,"geoPoint":518,"contacts":519},"Fred Hutch Cancer Center","Seattle","98109",{"type":44,"coordinates":515},[516,517],-122.33207,47.60621,{"lat":517,"lon":516},[520],{"name":521,"role":52,"phone":20,"phoneExt":20,"email":20},"Lynn Symonds, MD",{"facility":523,"status":37,"city":524,"state":500,"zip":525,"country":41,"countryCode":42,"cosmosGeoPoint":526,"geoPoint":530,"contacts":531},"MultiCare Cancer Institute","Tacoma","98405",{"type":44,"coordinates":527},[528,529],-122.44429,47.25288,{"lat":529,"lon":528},[532],{"name":533,"role":52,"phone":20,"phoneExt":20,"email":20},"Blair Irwin, MD",{"facility":535,"status":37,"city":536,"state":537,"zip":538,"country":41,"countryCode":42,"cosmosGeoPoint":539,"geoPoint":543,"contacts":544},"West Virginia University","Morgantown","West Virginia","26506",{"type":44,"coordinates":540},[541,542],-79.9559,39.62953,{"lat":542,"lon":541},[545],{"name":546,"role":52,"phone":20,"phoneExt":20,"email":20},"Bei Jiang, MD",{"type":548,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100609434","signatera-guided-cdk46-inhibitor-therapy-in-breast-cancer-100609434",false,"NCT07214532","Signatera-Guided CDK4\u002F6 Inhibitor Therapy in Breast Cancer","SIgnatera-Guided Initiation of Adjuvant CDK4\u002F6 Inhibitor in Intermediate Risk HR+ HER2- Breast Cancer","SIGNAL-ER 101","Inclusion Criteria:\n\n1. Signed and dated Informed Consent Form (ICF) obtained prior to any trial-specific screening procedure.\n2. Patient is ≥ 18 years-old at the time of ICF signature.\n3. Patient is female with known menopausal status at the time of initiation of adjuvant endocrine therapy (ET), or male.\n4. Patient with histologically confirmed unilateral and unifocal primary invasive adenocarcinoma of the breast prior to initiating adjuvant chemotherapy, if indicated, or within 6 months of initiating adjuvant endocrine therapy if chemotherapy is not indicated. Patients who receive neoadjuvant endocrine therapy or chemotherapy are allowed to enroll.\n5. Patient has breast cancer that is positive for ER and\u002For PR according to the local laboratory as determined on the most recently analyzed tissue sample.\n6. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test (FISH, CISH, or SISH) or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (ISH) test is required to confirm the HER2-negative status.\n7. Patient has available archival tumor tissue from the diagnostic biopsy or surgical specimen, for submission to a central laboratory for Signatera testing (unless Signatera Genome clinical testing has already been performed).\n8. Patient after surgical resection where tumor was removed completely (i.e., negative microscopic margins on final pathology) and have Anatomic Stage II that is either:\n\n   * N1 or,\n   * If N0, T2 or T3 with G2-3 and\u002For Ki67≥20% (testing for Ki67 not mandatory), excluding G1.\n\n   Notes:\n   1. Patients who received neoadjuvant treatment must meet the criteria for stage, grade, Ki67 in any presurgical staging\u002Fsample and\u002For in the surgical specimen.\n   2. Categorization into the AJCC 8th edition Anatomic Stage Groups requires determination of the T, N and M categories. ALND can be omitted.\n9. Patient has no contraindication to adjuvant ET and is planned to be treated with ET for 5 years (since enrollment date) or more.\n10. Provider and patient must be agreeable to initiate CDK4\u002F6 inhibitors only upon ctDNA detection.\n11. Patient may have received up to 6 months of standard adjuvant ET at the time of enrollment and any amount of neoadjuvant endocrine therapy.\n12. Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n13. Patient must not have a clinical contraindication to ribociclib or abemaciclib.\n14. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.\n15. Women of childbearing potential (CBP) must have a confirmed negative serum pregnancy test within 14 days prior to enrollment.\n16. Women of reproductive potential should be advised of the potential risk of CDK4\u002F6 inhibitors to a fetus, and use effective contraception during CDK 4\u002F6 inhibitor therapy.\n\nExclusion Criteria:\n\n1. Patient has had prior exposure to a CDK4\u002F6 inhibitor.\n2. Patient is concurrently using hormone replacement therapy.\n3. Patient with a known contraindication or hypersensitivity to ribociclib or abemaciclib as per the FDA indication label.\n4. Patients with a multicentric and\u002For multifocal and synchronous contralateral breast cancer are ineligible.\n5. Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and\u002For evidence of recurrence after curative surgery.\n6. Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 5 years before ICF signature. Note: Patients with prior or concurrent in situ malignancies are eligible provided that adequate curative treatment is completed prior to enrollment.\n7. Patient has any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, liver cirrhosis or any other significant liver disease, active untreated or uncontrolled fungal, bacterial or viral infections, active infection requiring systemic antibacterial therapy, etc.) or limit life expectancy to ≤5 years.\n8. Patient participated in another interventional study and received treatment with an investigational product (or used an investigational device) within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer.","ALL","18 Years",{"count":560,"type":561},725,"ESTIMATED","INTERVENTIONAL",[564],"NA","The purpose of this study is to evaluate the efficacy and safety of ctDNA-guided initiation of CDK4\u002F6 inhibitor therapy using the Signatera™ Designed on Genome test (referred to as \"Signatera Genome\") in participants with intermediate-risk HR+\u002FHER2- early-stage breast cancer. Based on ctDNA test results, participants will either start CDK4\u002F6 inhibitor therapy in addition to hormone therapy or continue hormone therapy with ongoing ctDNA surveillance. This study will compare outcomes to historical controls from the NataLEE trial to determine whether ctDNA-guided timing maintains efficacy while reducing unnecessary treatment. Participants will be followed for up to 9 years with regular blood draws, hormone therapy, imaging as needed, and quality-of-life assessments.",[567,568,569],"Breast Neoplasms","Carcinoma, Ductal, Breast","Receptors, Estrogen (for ER-positive Requirement)",[571,572,573,574,575,576,577,578,579,580,581,582,583,584,585,586,587],"ctDNA","Circulating tumor DNA","Signatera","CDK4\u002F6 inhibitor","Ribociclib","Abemaciclib","Molecular residual disease","MRD","Biomarker-guided therapy","Adjuvant therapy","Hormone receptor positive","HER2 negative","Early breast cancer","Intermediate risk breast cancer","breast cancer","Endocrine therapy","Tumor-informed assay","2026-04-02",{"date":590,"type":591},"2026-04-08","ACTUAL",{"date":593,"type":591},"2026-03-24",{"date":595,"type":561},"2037-12-30",{"name":5,"class":6},39]