[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537128":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":33,"armGroups":41,"interventions":47,"overallOfficials":52,"centralContacts":57,"locations":65,"responsibleParty":86,"collaborators":33,"id":88,"slug":33,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":33,"studyType":100,"phases":101,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":67,"whyStopped":33,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"The Netherlands Cancer Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"pCR rate","Number of patients achieving a pathological complete response","At 6 months",[14,17,20,23,27,30],{"measure":15,"description":16,"timeFrame":12},"Radiological reduction on tumor size","Number of patients achieving a radiological response (CR, PR, SD) based on MRI after neo adjuvant treatment",{"measure":18,"description":19,"timeFrame":12},"Pathological reduction on tumor size","Number of patients achieving a pathological response (CR, PR, SD) based on pathology report after neo adjuvant",{"measure":21,"description":22,"timeFrame":12},"Residual cancer burden (RCB)","quantificaton of the residual disease after neoadjuvant therapy",{"measure":24,"description":25,"timeFrame":26},"Distant recurrence free interval (DRFI)","Number of patients with distant recurrence","Up to 120 months",{"measure":28,"description":29,"timeFrame":26},"Recurrence-free interval (RFI)","Number of patients with disease recurrence",{"measure":31,"description":32,"timeFrame":26},"Overall survival (OS)","Number of patients alive or deceased",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":33,"timePerspective":33,"maskingInfo":39},"NA","SINGLE_GROUP","collection of serum sample blood at first day of neo adjuvant treatment","DIAGNOSTIC",{"masking":40,"maskingDescription":33,"whoMasked":33},"NONE",[42],{"label":43,"type":6,"description":44,"interventionNames":45},"Blood sample","Collection of serum blood sample at day of start neo adjuvant treatment",[46],"Procedure: Blood sample",[48],{"type":49,"name":43,"description":50,"armGroupLabels":51,"otherNames":33},"PROCEDURE","Collection of serum sample at the day of start of neo adjuvant treatment",[43],[53],{"name":54,"affiliation":55,"role":56},"Sabine Linn, MD","Antoni van Leeuwenhoek","PRINCIPAL_INVESTIGATOR",[58,62],{"name":54,"role":59,"phone":60,"phoneExt":33,"email":61},"CONTACT","+31205129111","s.linn@nki.nl",{"name":63,"role":59,"phone":33,"phoneExt":33,"email":64},"Ingrid Mandjes","i.mandjes@nki.nl",[66],{"facility":55,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"RECRUITING","Amsterdam","North Holland","1066CX","Netherlands","NL",{"type":74,"coordinates":75},"Point",[76,77],4.88969,52.37403,{"lat":77,"lon":76},[80,84,85],{"name":81,"role":59,"phone":82,"phoneExt":33,"email":83},"Sarah Pruckl, PhD","0205129111","chemosense@nki.nl",{"name":63,"role":59,"phone":33,"phoneExt":33,"email":64},{"name":54,"role":56,"phone":33,"phoneExt":33,"email":33},{"type":87,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100537128",false,"NCT06273800","Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients","Chemosense","Inclusion Criteria:\n\n* Women with a new diagnosis of triple negative breast cancer who have not yet started systemic treatment.\n* Patients with stage I-III disease, patient with locoregional recurrence who have not been treated with chemotherapy before. ,\n* Aged \\\u003C 60 years\n* Women having a (regular) physiological menstrual cycle\n* Patients who are assigned to receive neoadjuvant chemotherapy with or without immunotherapy, targeted therapy and endocrine therapy\n* Patients must be systemic treatment naïve for current malignancy (e.g. no chemotherapy, hormonal therapy or targeted therapy)\n* Signed written informed consent\n\nExclusion Criteria:\n\n* current use of hormonal contraception or in the six weeks prior to start of neoadjuvant systemic treatment for breast cancer, such as:\n* Oral contraception (OAC)\n* Hormonal intra-uterine device (IUD, Mirena)\n* No ovarian function suppression to preserve fertility\n* Other forms of hormonal contraception, including but not limited to: nuva-ring, Implanon, prikpil\n* Currently pregnant and \u002F or breast feeding. In case of use of hormonal contraception or breast feeding in de last year: patients should have had at least 2 menstrual cycles since stopping hormonal contraception.\n\n  \\- active other malignancy\n* IVF-trajectory for egg cell preservation prior to start of neoadjuvant systemic treatment","FEMALE","18 Years","59 Years",{"count":98,"type":99},100,"ESTIMATED","INTERVENTIONAL",[35],"This study is a prospective, multicenter study in which a serum sample will be collected at the day of starting neo adjuvant treatment in breast cancer patients",[104],"Breast Cancer",[106,107,108,109],"Triple negative tumor","Stage I - III disease","Starting neo adjuvant treatment","Regular physiological menstrual cycle (premenopausal)","2025-11-21",{"date":112,"type":113},"2025-11-26","ACTUAL",{"date":115,"type":113},"2025-10-14",{"date":117,"type":99},"2036-07-15",{"name":5,"class":6},1]