[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604622":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":46,"collaborators":10,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":10,"enrollmentInfo":58,"targetDuration":10,"studyType":61,"phases":10,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Azienda Ospedaliero-Universitaria di Modena","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ADJUVANT IN EBC",null,"High-risk HR positive, Her2 negative early breast cancer patients receiving abemaciclib, olaparib and endocrine therapy.",[13],"Drug: abemaciclib, olaparib and endocrine therapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","abemaciclib, olaparib and endocrine therapy","Patients receiving abemaciclib, olaparib and endocrine therapy.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Luca Moscetti, MD","CONTACT","+ 39.059.422.3244","moscetti.luca@aou.mo.it",[27],{"facility":28,"status":29,"city":30,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Azienda Ospedaliero Universitaria Policlinico di Modena","RECRUITING","Modena","41124","Italy","IT",{"type":35,"coordinates":36},"Point",[37,38],10.92539,44.64783,{"lat":38,"lon":37},[41,44],{"name":22,"role":23,"phone":42,"phoneExt":43,"email":25},"0594223244","0039",{"name":22,"role":45,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":45,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Luca Moscetti","Principal Investigator","100604622","real-world-study-in-the-adjuvant-setting-for-high-risk-early-breast-cancer-patients-100604622",false,"NCT07151911","Real wOrld studY in the Adjuvant Setting for High Risk earLy Breast Cancer Patients","ROYAL","Inclusion Criteria:\n\n* Patients will be enrolled in the study if they meet all of the following inclusion criteria:\n* Age ≥ 18 years\n* Endocrine sensitivity defined as estrogen and or progesterone receptors expression as per local pathological standards\n* Her 2 negativity determined as ASCO\u002FCAP guidelines\n* Patients receiving abemaciclib, olaparib and endocrine therapy, as per Italian drugs agency rules (AIFA)\n* Written informed consent, signed and dated by the patients\n* High-risk HR positive, Her2 negative early breast cancer patients with one of the following characteristics:\n\n  * Anatomical stage IIA N0 with:\n\n    * Grade 2 and evidence of high risk:\n    * Ki-67 ≥ 20%\n    * Oncotype DX Breast Recurrence Score ≥ 26 or High risk via genomic risk profiling\n    * Grade 3\n  * Anatomical stage IIB.\n  * Pathological tumour involvement in ≥4 ipsilateral axillary lymph nodes.\n  * Pathological tumour involvement in 1 to 3 ipsilateral axillary lymph node(s) (for patients who received neoadjuvant therapy also cytological tumour involvement at time of initial diagnosis is allowed) and meet at least 1 of the following criteria:\n\n    * Grade 3 as defined by a combined score of at least 8 points per the modified Bloom-Richardson grading system (Elston and Ellis 1991),\n    * Pathological primary invasive tumour size ≥5 cm (for patients who received neoadjuvant therapy primary tumour size ≥5 cm on breast imaging is allowed). Note: if tumour size is needed to meet eligibility criteria, patients with multifocal\u002Fmulticentric tumours may be eligible based on the addition of diameters of the individual lesions.\n\nBRCA mutated populations\n\nPatients must be node positive and fulfil one of the following criteria:\n\n* HR positive, HER2-negative patients must have had ≥4 pathologically confirmed positive lymph nodes\n* patients who received prior neoadjuvant chemotherapy: must have had a CPS\\&EG score of ≥3 based on pre-treatment clinical and post-treatment pathologic stage (CPS), estrogen receptor (ER) status and histologic grade\n\nExclusion Criteria:\n\n* Patients unable to understand the reason for their participation in the study, lack of informed written consent,\n* patients who do not meet the high risk criteria as specified in the inclusion criteria,\n* patients suffering from other neoplasms for which they receive active treatment, or being diagnosed with other neoplasms (except for: Carcinoma in situ (CIS) of the cervix, CIS of the colon, basal cell and squamous cell carcinomas of the skin) in the five years before adjuvant treatment.","ALL","18 Years",{"count":59,"type":60},100,"ESTIMATED","OBSERVATIONAL","The primary goal of this observational study is to describe the distribution of treatment options and patients' characteristics according to the definition of high-risk status in the early breast cancer (EBC) setting. Participants already taking intervention as part of their regular medical care for EBC will answer questionnaires to also assess quality of life and patient reported outcomes.\n\nThe recruitment phase will last about 2 years, each patient will be followed up for 5 years.",[64],"Breast Cancer",[66,67,68,69,70],"Breast cancer","Adjuvant treatment","Safety","Quality of life","Patient reported outcome","2025-09-02",{"date":73,"type":74},"2025-09-03","ACTUAL",{"date":76,"type":74},"2024-08-26",{"date":78,"type":60},"2031-09",{"name":5,"class":6},1]