[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100462551":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":19,"centralContacts":19,"locations":20,"responsibleParty":40,"collaborators":19,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":19,"enrollmentInfo":53,"targetDuration":19,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":67,"whyStopped":19,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Centre Francois Baclesse","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Blood tests","Realization of 4 blood tests for Lymphocyte typing (Neutrophil\u002FLymphocyte ratio (NLR), CD4+ and CD8+ lymphocyte counts ), during CDK4\u002F6 treatment :\n\n* before initiation of CDK4\u002F6 treatment\n* At 3 mois after initiation of CDK4\u002F6 treatment\n* At 6 mois after initiation of CDK4\u002F6 treatment\n* At 12 mois after initiation of CDK4\u002F6 treatment or at early end of study",[12],"Biological: Blood sampling",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Blood sampling","Blood sampling for Lymphocyte typing (Neutrophil\u002FLymphocyte ratio (NLR), CD4+ and CD8+ lymphocyte counts )",[9],null,[21,32],{"facility":22,"status":19,"city":23,"state":19,"zip":19,"country":24,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":19},"Centre François Baclesse","Caen","France","FR",{"type":27,"coordinates":28},"Point",[29,30],-0.35912,49.18585,{"lat":30,"lon":29},{"facility":33,"status":19,"city":34,"state":19,"zip":19,"country":24,"countryCode":25,"cosmosGeoPoint":35,"geoPoint":39,"contacts":19},"Centre Henri BECQUEREL","Rouen",{"type":27,"coordinates":36},[37,38],1.09932,49.44313,{"lat":38,"lon":37},{"type":41,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100462551","prognostic-impact-of-the-neutrophillymphocyte-ratio-nlr-in-the-treatment-of-first-line-metastatic-or-locally-advanced-breast-cancer-treated-with-cdk46-inhibitor-100462551",true,"NCT05303129","Prognostic Impact of the Neutrophil\u002FLymphocyte Ratio (NLR) in the Treatment of First-line Metastatic or Locally Advanced Breast Cancer Treated With CDK4\u002F6 Inhibitor.","Prognostic Impact of the Neutrophil\u002FLymphocyte Ratio (NLR) in the Treatment of First-line Metastatic or Locally Advanced Breast Cancer Treated With CDK4\u002F6 in","PEPSI","Inclusion Criteria:\n\n* Patients with locally advanced or metastatic HR-positive, Her2-negative breast cancer\n* Patients who are scheduled to receive first-line metastatic CDK4\u002F6 inhibitor therapy in combination with hormone therapy as per the marketing authorization\n* Patients who have not received previous anti-neoplastic therapies for metastatic or advanced disease (chemotherapy, targeted therapy or hormonal therapy). However, it will be possible to have initiated 1st line hormonal therapy within 4 to 6 weeks prior to inclusion.\n* Prior radiotherapy allowed even in metastatic disease. In case of radiotherapy treatment, side effects attributable to the treatment must be resolved.\n* Postmenopausal patients or patients with suppressed ovarian function\n* Patient with measurable or non-measurable disease (according to RECIST v1.1 criteria)\n* Adequate organ and marrow function to allow prescription of CDK 4\u002F6 inhibitor therapy\n* Age of Patient ≥ 18 years\n* Willingness and ability to comply with scheduled visits, treatment plan, biologic tests and other trial procedures including assessments requested for inclusion\n* Patient affiliated with a social security plan\n* Informed consent signed prior to any specific study-related procedures\n\nExclusion Criteria:\n\n* Men (no marketing authorization for CDK4\u002F6 inhibitors in men in France)\n* Previous systemic treatment for metastatic disease (chemotherapy, hormone therapy, etc.)\n* Previous treatment with a CDK4\u002F6 inhibitor (adjuvant or for metastatic disease)\n* Locally advanced or relapsed breast cancer for which curative treatment would be considered\n* Her2-positive tumor status on either the primary or relapsed tumor as defined by ASCO criteria\n* Patient with advanced, symptomatic visceral extension who may be at risk for a potentially fatal short-term complication (\"visceral crisis\") and who requires treatment with chemotherapy\n* Patients who are deprived of their liberty, under guardianship, or subject to a legal protection measure or who are unable to express their consent\n* Patients who cannot undergo the trial follow-up for geographical, social or psychopathological reasons",false,"FEMALE","18 Years",{"count":54,"type":55},165,"ACTUAL","INTERVENTIONAL",[58],"NA","The impact of the inflammatory microenvironment in predicting the benefit of a CDK4\u002F6 inhibitor in the treatment of locally advanced or first line metastatic breast cancer has not yet been studied.\n\nWe propose a multicenter prospective study to confirm the prognostic value of pre-therapy NLR on progression-free survival of patients initiating treatment with a CDK4\u002F6 inhibitor combined with hormonal therapy for locally advanced or metastatic HR-pos \u002F HER2-neg breast cancer.\n\nWe will also evaluate other markers of inflammation and their prognostic and predictive value for a better response to CDK4\u002F6 inhibitor therapy in combination with hormone therapy in these patients.\n\nSpecific blood tests (lymphocyte typing) will be performed during treatment with CDK4\u002F6.",[61,62],"Breast Cancer","Metastatic Breast Cancer",[64,65,66],"CDK4\u002F6","lymphocyte typing","Neutrophil\u002FLymphocyte ratio (NLR)","COMPLETED","2026-05-15",{"date":70,"type":55},"2026-06-11",{"date":72,"type":55},"2022-05-27",{"date":74,"type":55},"2024-12-17",{"name":5,"class":6},2]