[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552671":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":36,"locations":44,"responsibleParty":361,"collaborators":363,"id":369,"slug":370,"hasResults":371,"nctId":372,"briefTitle":373,"officialTitle":373,"acronym":374,"eligibilityCriteria":375,"healthyVolunteers":371,"sex":376,"minAge":377,"maxAge":10,"enrollmentInfo":378,"targetDuration":10,"studyType":381,"phases":10,"briefSummary":382,"conditions":383,"keywords":386,"overallStatus":58,"whyStopped":10,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":397},{"fullName":5,"class":6},"The Netherlands Cancer Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Optimisation cohort",null,"patients will be treated with surgery and adjuvant radiotherapy following local\u002Fnational guidelines, while chemotherapy will be omitted",[13],"Other: No adjuvant chemotherapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Control cohort","patients will be treated with surgery, adjuvant radiotherapy and adjuvant chemotherapy following local\u002Fnational guidelines",[18],"Drug: Adjuvant chemotherapy",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Adjuvant chemotherapy","adjuvant chemotherapy according to local\u002F national guidelines",[15],[26],"according to local\u002F national guidelines",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"No adjuvant chemotherapy","no adjuvant chemotherapy",[9],[32],{"name":33,"affiliation":34,"role":35},"Marleen Kok, MD","Antoni van Leeuwenhoek","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":10,"email":40},"CONTACT","+31205129111","m.kok@nki.nl",{"name":42,"role":38,"phone":39,"phoneExt":10,"email":43},"Rianne Rolfes, MD","r.rolfes@nki.nl",[45,56,71,82,95,106,122,130,141,152,163,174,185,193,204,215,226,237,248,260,271,282,293,305,317,328,339,350],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":10,"geoPoint":10,"contacts":53},"Zuyderland Medisch Centrum","NOT_YET_RECRUITING","Sittard-Geleen","Limburg","6162 BG","Netherlands","NL",[54],{"name":55,"role":38,"phone":10,"phoneExt":10,"email":10},"F van den Berkmortel, MD",{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":51,"countryCode":52,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Medical spectrum Twente","RECRUITING","Enschede","Overijssel","7500 KA",{"type":63,"coordinates":64},"Point",[65,66],6.89583,52.21833,{"lat":66,"lon":65},[69],{"name":70,"role":38,"phone":10,"phoneExt":10,"email":10},"M Wymenga, MD",{"facility":72,"status":47,"city":73,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Noordwest Ziekenhuisgroep","Alkmaar",{"type":63,"coordinates":75},[76,77],4.74861,52.63167,{"lat":77,"lon":76},[80],{"name":81,"role":38,"phone":10,"phoneExt":10,"email":10},"S Vrijaldenhoven, MD",{"facility":83,"status":47,"city":84,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Flevoziekenhuis","Almere Stad",{"type":63,"coordinates":86},[87,88],5.21413,52.37025,{"lat":88,"lon":87},[91,93],{"name":92,"role":38,"phone":10,"phoneExt":10,"email":10},"S A.L Bartels, MD",{"name":94,"role":38,"phone":10,"phoneExt":10,"email":10},"S A.L. Bartels, MD",{"facility":96,"status":58,"city":97,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Meander Medisch Centrum","Amersfoort",{"type":63,"coordinates":99},[100,101],5.3875,52.155,{"lat":101,"lon":100},[104],{"name":105,"role":38,"phone":10,"phoneExt":10,"email":10},"J M Baas, MD",{"facility":34,"status":58,"city":107,"state":10,"zip":108,"country":51,"countryCode":52,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Amsterdam","1066 CX",{"type":63,"coordinates":110},[111,112],4.88969,52.37403,{"lat":112,"lon":111},[115,118,121],{"name":33,"role":38,"phone":116,"phoneExt":117,"email":40},"+3120512","9111",{"name":119,"role":38,"phone":116,"phoneExt":117,"email":120},"Ingrid AM Mandjes, MSc","i.mandjes@nki.nl",{"name":33,"role":38,"phone":10,"phoneExt":10,"email":10},{"facility":123,"status":58,"city":107,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":124,"geoPoint":126,"contacts":127},"Onze Lieve Vrouwe Gasthuis (OLVG)",{"type":63,"coordinates":125},[111,112],{"lat":112,"lon":111},[128],{"name":129,"role":38,"phone":10,"phoneExt":10,"email":10},"B Flameling, MD",{"facility":131,"status":58,"city":132,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Rijnstate","Arnhem",{"type":63,"coordinates":134},[135,136],5.91111,51.98,{"lat":136,"lon":135},[139],{"name":140,"role":38,"phone":10,"phoneExt":10,"email":10},"K Beelen, MD",{"facility":142,"status":58,"city":143,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Amphia ziekenhuis","Breda",{"type":63,"coordinates":145},[146,147],4.77596,51.58656,{"lat":147,"lon":146},[150],{"name":151,"role":38,"phone":10,"phoneExt":10,"email":10},"J Heijns, MD",{"facility":153,"status":58,"city":154,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Deventer Ziekenhuis","Deventer",{"type":63,"coordinates":156},[157,158],6.16389,52.255,{"lat":158,"lon":157},[161],{"name":162,"role":38,"phone":10,"phoneExt":10,"email":10},"L. Kessels, MD, PhD",{"facility":164,"status":58,"city":165,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"Ziekenhuis Gelderse Vallei","Ede",{"type":63,"coordinates":167},[168,169],5.65833,52.03333,{"lat":169,"lon":168},[172],{"name":173,"role":38,"phone":10,"phoneExt":10,"email":10},"M Verstappen, MD",{"facility":175,"status":58,"city":176,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Catharina Ziekenhuis","Eindhoven",{"type":63,"coordinates":178},[179,180],5.47778,51.44083,{"lat":180,"lon":179},[183],{"name":184,"role":38,"phone":10,"phoneExt":10,"email":10},"R-J Schipper, MD",{"facility":186,"status":58,"city":176,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":187,"geoPoint":189,"contacts":190},"Jeroen Bosch ziekenhuis",{"type":63,"coordinates":188},[179,180],{"lat":180,"lon":179},[191],{"name":192,"role":38,"phone":10,"phoneExt":10,"email":10},"J Tol, MD",{"facility":194,"status":58,"city":195,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"St. Jansdal","Harderwijk",{"type":63,"coordinates":197},[198,199],5.62083,52.34167,{"lat":199,"lon":198},[202],{"name":203,"role":38,"phone":10,"phoneExt":10,"email":10},"J A Ropela, MD",{"facility":205,"status":58,"city":206,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"Ziekenhuisgroep Twente","Hengelo",{"type":63,"coordinates":208},[209,210],6.79306,52.26583,{"lat":210,"lon":209},[213],{"name":214,"role":38,"phone":10,"phoneExt":10,"email":10},"E Siemerink, MD",{"facility":216,"status":58,"city":217,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"Tergooi ziekenhuizen","Hilversum",{"type":63,"coordinates":219},[220,221],5.17639,52.22333,{"lat":221,"lon":220},[224],{"name":225,"role":38,"phone":10,"phoneExt":10,"email":10},"A Willemsen, MD",{"facility":227,"status":58,"city":228,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"Spaarne Gasthuis","Hoofddorp",{"type":63,"coordinates":230},[231,232],4.68889,52.3025,{"lat":232,"lon":231},[235],{"name":236,"role":38,"phone":10,"phoneExt":10,"email":10},"B de Valk, MD",{"facility":238,"status":47,"city":239,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Dijklander ziekenhuis","Hoorn",{"type":63,"coordinates":241},[242,243],5.05972,52.6425,{"lat":243,"lon":242},[246],{"name":247,"role":38,"phone":10,"phoneExt":10,"email":10},"M M Vleugel, MD",{"facility":249,"status":47,"city":250,"state":10,"zip":251,"country":51,"countryCode":52,"cosmosGeoPoint":252,"geoPoint":256,"contacts":257},"MCL","Leeuwarden","8934 AD",{"type":63,"coordinates":253},[254,255],5.80973,53.20271,{"lat":255,"lon":254},[258],{"name":259,"role":38,"phone":10,"phoneExt":10,"email":10},"L Hamming, MD",{"facility":261,"status":47,"city":262,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":263,"geoPoint":267,"contacts":268},"LUMC","Leiden",{"type":63,"coordinates":264},[265,266],4.49306,52.15833,{"lat":266,"lon":265},[269],{"name":270,"role":38,"phone":10,"phoneExt":10,"email":10},"J Kroep, MD",{"facility":272,"status":47,"city":273,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":274,"geoPoint":278,"contacts":279},"MUMC","Maastricht",{"type":63,"coordinates":275},[276,277],5.68889,50.84833,{"lat":277,"lon":276},[280],{"name":281,"role":38,"phone":10,"phoneExt":10,"email":10},"M de Boer, MD",{"facility":283,"status":58,"city":284,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":285,"geoPoint":289,"contacts":290},"St. Antonius ziekenhuis","Nieuwegein",{"type":63,"coordinates":286},[287,288],5.08056,52.02917,{"lat":288,"lon":287},[291],{"name":292,"role":38,"phone":10,"phoneExt":10,"email":10},"M J Agterof, MD",{"facility":294,"status":47,"city":295,"state":10,"zip":296,"country":51,"countryCode":52,"cosmosGeoPoint":297,"geoPoint":301,"contacts":302},"Radboud UMC","Nijmegen","6225GA",{"type":63,"coordinates":298},[299,300],5.85278,51.8425,{"lat":300,"lon":299},[303],{"name":304,"role":38,"phone":10,"phoneExt":10,"email":10},"E Kuip, MD",{"facility":306,"status":47,"city":307,"state":10,"zip":308,"country":51,"countryCode":52,"cosmosGeoPoint":309,"geoPoint":313,"contacts":314},"Erasmus Medical Center Cancer Institute","Rotterdam","3015CE",{"type":63,"coordinates":310},[311,312],4.47917,51.9225,{"lat":312,"lon":311},[315],{"name":316,"role":38,"phone":10,"phoneExt":10,"email":10},"A Jager, MD",{"facility":318,"status":58,"city":319,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":320,"geoPoint":324,"contacts":325},"Franciscus Gasthuis & Vlietland","Schiedam",{"type":63,"coordinates":321},[322,323],4.38889,51.91917,{"lat":323,"lon":322},[326],{"name":327,"role":38,"phone":10,"phoneExt":10,"email":10},"J.M. Zuetenhorst, dr.",{"facility":329,"status":58,"city":330,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":331,"geoPoint":335,"contacts":336},"Haaglanden Medisch Centrum","The Hague",{"type":63,"coordinates":332},[333,334],4.29861,52.07667,{"lat":334,"lon":333},[337],{"name":338,"role":38,"phone":10,"phoneExt":10,"email":10},"R. Oosterkamp, MD, PhD",{"facility":340,"status":47,"city":341,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":342,"geoPoint":346,"contacts":347},"VieCuri Medisch Centrum voor Noord-Limburg","Venlo",{"type":63,"coordinates":343},[344,345],6.16806,51.37,{"lat":345,"lon":344},[348],{"name":349,"role":38,"phone":10,"phoneExt":10,"email":10},"E Boon, MD",{"facility":351,"status":58,"city":352,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":353,"geoPoint":357,"contacts":358},"Isala","Zwolle",{"type":63,"coordinates":354},[355,356],6.09444,52.5125,{"lat":356,"lon":355},[359],{"name":360,"role":38,"phone":10,"phoneExt":10,"email":10},"A Honkoop, MD",{"type":362,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[364,367],{"name":365,"class":366},"Maarten van de Weijden Foundation","UNKNOWN",{"name":368,"class":366},"AVL Foundation","100552671","optimaloptimisation-of-treatment-for-patients-with-low-stage-triple-negative-breast-cancer-with-high-stromal-tumor-infiltrating-lymphocytes-100552671",false,"NCT06476119","OPTImaL:Optimisation of Treatment for Patients With Low Stage Triple-negative Breast Cancer With High Stromal Tumor-infiltrating Lymphocytes","OPTImaL","Inclusion Criteria:\n\n* Female or male patients;\n* \\>=18 years;\n* Written informed consent;\n* TNBC (defined as: invasive carcinoma; ER\u002FPR expression 0-9%; Human Epidermal Growth Factor Receptor 2 \\[HER2\\] negative \\[0, 1+ or 2+ on immunohistochemistry, without HER2 amplification on in-situ hybridization\\]) on the diagnostic biopsy and the surgical specimen;\n* Pathological stage I TNBC (according to the TNM staging 8th edition):\n\n  * pT1a\u002Fb\u002Fc (≤2 cm), confirmed by an invasive component of ≤2 cm on the surgical specimen (microinvasive disease \\[pT1mi, ≤1 mm) is not allowed);\n  * pN0, confirmed by absence of malignant cells in the sentinel lymph node or any other lymph node after surgery (isolated tumor cells \\[N0(i+)\\] are not allowed);\n* No evidence of nodal or distant metastases (cN0M0) on pre and\u002For postoperative imaging examinations (performed following local\u002Fnational guidelines, but must include an 18F-fluorodeoxyglucose positron emission tomography\u002Fcomputed tomography \\[18F-FDG-PET\u002FCT, at least from skull base to upper legs\\] or computed tomography \\[CT\\] of neck\u002Fchest\u002Fabdomen\u002Fpelvis \\[CT only if 18F-FDG-PET\u002FCT would not be available; 18F-FDG-PET\u002FCT mandatory in the Netherlands\\]);\n* sTIL score of ≥50% for patients ≥40 years at the time of TNBC diagnosis and ≥75% for patients \\\u003C40 years at the time of TNBC diagnosis on an H\\&E FFPE tissue slide on the surgical specimen, according to International Immuno-Oncology Biomarker Working Group on Breast Cancer (formerly International TILs Working Group) guidelines, by local and central review\n* Has undergone curative breast surgery (breast-conserving surgery or mastectomy and surgical axillary staging \\[including at least sentinel lymph node procedure\\]);\n* Absence of recurrence between curative breast surgery and expression of patient preference;\n* Eligible for radiotherapy (if indicated).\n\nExclusion Criteria:\n\n* Prior disease history of invasive and\u002For non-invasive breast cancer, or ongoing treatment for invasive and\u002For non-invasive breast cancer;\n* Multifocal, multicentric or bilateral breast cancer at the time of screening;\n* Administration of neoadjuvant systemic therapy;\n* Presence of lymphovascular invasion on the diagnostic biopsy and\u002For the surgical specimen;\n* Other invasive malignancy within 5 years prior to inclusion, with the exception of ade-quately treated non-melanoma skin cancer, localized cervical cancer, localized and Gleason ≤6 prostate cancer;\n* Uncontrolled severe illness or medical condition;\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the in the trial.","ALL","18 Years",{"count":379,"type":380},490,"ESTIMATED","OBSERVATIONAL","The aim of this study is to investigate whether subjects with breast cancer that have certain favorable features, after performing the surgery and radiation, the chemotherapy can be safely omitted in the treatment. In addition, the investigation looks at whether the omission of chemotherapy ensures a better quality of life. Participants decide, in consultation with their treating physician, whether they choose to be treated with adjuvant chemotherapy or not.",[384,385],"Breast Cancer Stage I","Triple Negative Breast Cancer (TNBC)",[387],"High (stromal Tumor-Infiltrating-Lymphocytes) sTIL score","2025-04-17",{"date":390,"type":391},"2025-04-23","ACTUAL",{"date":393,"type":391},"2025-04-15",{"date":395,"type":380},"2034-09-15",{"name":5,"class":6},28]