[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100444446":3},{"organization":4,"armGroups":7,"interventions":33,"overallOfficials":45,"centralContacts":49,"locations":60,"responsibleParty":155,"collaborators":45,"id":157,"slug":158,"hasResults":159,"nctId":160,"briefTitle":161,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":159,"sex":164,"minAge":165,"maxAge":45,"enrollmentInfo":166,"targetDuration":45,"studyType":169,"phases":170,"briefSummary":172,"conditions":173,"keywords":45,"overallStatus":175,"whyStopped":45,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},{"fullName":5,"class":6},"Medical University of Gdansk","OTHER",[8,14,20,24,29],{"label":9,"type":10,"description":11,"interventionNames":12},"CDK4\u002F6 inhibitor alone: Palbociclib (IMP)","EXPERIMENTAL","Palbociclib alone (125 mg orally (PO) per day, days 1-14)",[13],"Drug: Palbociclib",{"label":15,"type":16,"description":17,"interventionNames":18},"Chemotherapy alone: Paclitaxel","ACTIVE_COMPARATOR","Paclitaxel alone (80 mg\u002Fm\\^2 intravenously (IV), day 1, 8, 15 and 22)",[19],"Drug: Paclitaxel",{"label":21,"type":10,"description":22,"interventionNames":23},"CDK4\u002F6 inhibitor + chemotherapy: Paclitaxel + Palbociclib","Paclitaxel (80 mg\u002Fm\\^2 IV, day 1, 8, 15 and 22) + Palbociclib (125 mg PO per day, days 1-21)",[13,19],{"label":25,"type":16,"description":26,"interventionNames":27},"Chemotherapy alone: Carboplatin","Carboplatin alone (area under the curve (AUC) 2 IV, day 1, 8, 15 and 22)",[28],"Drug: Carboplatin",{"label":30,"type":10,"description":31,"interventionNames":32},"CDK4\u002F6 inhibitor + chemotherapy: Carboplatin + Palbociclib","Carboplatin (AUC 2 IV, day 1, 8, 15 and 22) + Palbociclib (125 mg PO per day, days 1-21)",[13,28],[34,41,46],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"DRUG","Palbociclib","CDK4\u002F6 inhibitor",[30,21,9],[40],"Ibrance",{"type":35,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Paclitaxel","Chemotherapy",[21,15],null,{"type":35,"name":47,"description":43,"armGroupLabels":48,"otherNames":45},"Carboplatin",[30,25],[50,56],{"name":51,"role":52,"phone":53,"phoneExt":54,"email":55},"Elżbieta Senkus-Konefka, MD, PhD","CONTACT","58 584 4482","0048","elzbieta.senkus-konefka@gumed.edu.pl",{"name":57,"role":52,"phone":58,"phoneExt":54,"email":59},"Monika Puchowska, MSc","58 349 1885","monika.puchowska@gumed.edu.pl",[61,80,96,111,127,139],{"facility":62,"status":45,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie, Oddział Onkologii Klinicznej i Immunoonkologii z Pododdziałem Dziennym","Poznan","Greater Poland Voivodeship","61 885 05 57","Poland","PL",{"type":69,"coordinates":70},"Point",[71,72],16.92993,52.40692,{"lat":72,"lon":71},[75,78],{"name":76,"role":52,"phone":65,"phoneExt":54,"email":77},"Maria Małgorzata Litwiniuk, MD, PhD","maria.litwiniuk@wco.pl",{"name":76,"role":79,"phone":45,"phoneExt":45,"email":45},"PRINCIPAL_INVESTIGATOR",{"facility":81,"status":45,"city":82,"state":83,"zip":84,"country":66,"countryCode":67,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Dolnośląskie Centrum Onkologii we Wrocławiu, Oddział Onkologii Klinicznej\u002FChemioterapii, Poradnia Chemioterapii; Leczenie Nowotworów Piersi","Wroclaw","Lower Silesian Voivodeship","53-413",{"type":69,"coordinates":86},[87,88],17.03006,51.10286,{"lat":88,"lon":87},[91,95],{"name":92,"role":52,"phone":93,"phoneExt":54,"email":94},"Aleksandra Łacko, MD, PhD","71 368 94 83","aleksandra.lacko@umed.wroc.pl",{"name":92,"role":79,"phone":45,"phoneExt":45,"email":45},{"facility":97,"status":45,"city":98,"state":99,"zip":100,"country":66,"countryCode":67,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie","Warsaw","Masovian Voivodeship","22 546 20 00",{"type":69,"coordinates":102},[103,104],21.01178,52.22977,{"lat":104,"lon":103},[107,110],{"name":108,"role":52,"phone":100,"phoneExt":54,"email":109},"Agnieszka Jagiełło-Gruszfeld, MD, PhD","agnieszka.jagiello-gruszfeld@gmail.com",{"name":108,"role":79,"phone":45,"phoneExt":45,"email":45},{"facility":112,"status":45,"city":113,"state":114,"zip":115,"country":66,"countryCode":67,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"SP ZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego","Opole","Opole Voivodeship","45-061",{"type":69,"coordinates":117},[118,119],17.92604,50.67119,{"lat":119,"lon":118},[122,126],{"name":123,"role":52,"phone":124,"phoneExt":54,"email":125},"Barbara Stefania Radecka, MD, PhD","77 441 60 01","brad@onkologia.opole.pl",{"name":123,"role":79,"phone":45,"phoneExt":45,"email":45},{"facility":128,"status":45,"city":129,"state":130,"zip":131,"country":66,"countryCode":67,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii","Gdansk","Pomeranian Voivodeship","80-952",{"type":69,"coordinates":133},[134,135],18.64912,54.35227,{"lat":135,"lon":134},[138],{"name":51,"role":79,"phone":45,"phoneExt":45,"email":45},{"facility":140,"status":45,"city":141,"state":142,"zip":143,"country":66,"countryCode":67,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie, Państwowy Instytut Badawczy, Oddział w Gliwicach","Gliwice","Silesian Voivodeship","44-102",{"type":69,"coordinates":145},[146,147],18.67658,50.29761,{"lat":147,"lon":146},[150,154],{"name":151,"role":52,"phone":152,"phoneExt":54,"email":153},"Michał Jarząb, MD, PhD","32 278 88 86","michal.jarzab@io.gliwice.pl",{"name":151,"role":79,"phone":45,"phoneExt":45,"email":45},{"type":156,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100444446","phase-2-cyclin-dependent-kinase-in-triple-negative-breast-cancer---a-window-of-opportunity-study-100444446",false,"NCT05067530","Cyclin dEpendent Kinase in tRiple nEGatIVe brEast canceR - a \"Window of Opportunity\" Study","CAREGIVER","Inclusion Criteria:\n\n* females or males \\>18 years old at the time of informed consent signature;\n* diagnosis of potentially resectable or de novo metastatic (stage II-IV) invasive carcinoma of the breast;\n* eligible for standard neoadjuvant or palliative paclitaxel and\u002For carboplatin-based chemotherapy as determined by Investigator;\n* triple negative tumor defined as:\n\n  * hormone receptor-negative (\\\u003C1% ER\u002FPgR expression);\n  * HER2-negative (Immunohistochemistry (IHC) score ≤1 or IHC score =2 and negative for the amplification by in situ hybridization);\n* multicentric\u002Fmultifocal disease is allowed, provided that all lesions have been biopsied and their phenotype has been confirmed pathologically as TNBC;\n* no previous anticancer therapy for this malignancy;\n* clinically or radiographically measurable disease (discrete lesion only, enhancement is not included) within the breast, that can be biopsied, defined as longest diameter \\>2 cm;\n* multicentric or multifocal disease is allowed if at least 1 lesion is \\>2 cm;\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n* adequate bone marrow and organ function as defined by the following local laboratory values:\n* hemoglobin ≥9 g\u002FdL;\n* absolute neutrophil count (ANC) ≥1500\u002FμL;\n* platelets ≥100,000\u002FμL;\n* total bilirubin ≤ institutional upper limit of normal (ULN), unless diagnosis of Gilbert syndrome;\n* aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x ULN;\n* creatinine ≤ ULN OR creatinine clearance ≥50 mL\u002Fmin per Cockcroft-Gault equation for patients with creatinine levels greater than ULN.\n* blood glucose level \\\u003C120 mg\u002FdL after at least 6 hours of fasting;\n* standard 12-lead electrocardiogram (ECG) without clinically significant abnormalities;\n* ability to undergo contrast-enhanced MRI;\n* ability to swallow and retain oral medication;\n* all study participants of child-bearing potential must agree to use adequate contraceptive methods prior to study entry, during the study and for the following 3 weeks (females) or 14 weeks (males);\n* prior chemotherapy, other targeted anticancer therapies, or prior radiation therapy (outside of treated breast) for other malignancy treated with radical intent is allowed, provided the treatment was completed ≥1 year before informed consent signature;\n* prior bisphosphonate therapy is allowed;\n* willing and able to undergo all the procedures required by the study protocol;\n* provision of written informed consent form prior to receiving any study related procedure.\n\nExclusion Criteria:\n\n* inflammatory breast cancer;\n* prior systemic treatment for this malignancy;\n* prior treatment with CDK4\u002F6 inhibitor;\n* known hypersensitivity to study medications or any of their excipients;\n* major surgery or radiotherapy (apart from limited field radiotherapy for symptom control) within 14 days prior to randomization;\n* concurrent invasive malignancy;\n* known HIV, active HBV or HCV infection;\n* active autoimmune disease requiring ongoing immunosuppressive therapy;\n* history of allotransplantation;\n* concurrent treatment with systemic immunosuppressive agents, including steroids, within 3 weeks of enrolment;\n* presence of implants or devices not compatible with MRI;\n* pregnant or nursing female participants;\n* receiving strong inhibitors or inducers of CYP3A4\u002F5 or medications with narrow therapeutic window that are predominantly metabolized through CYP3A4\u002F5;\n* impairment of GI function that may significantly alter the absorption of the oral trial treatments;\n* unwilling or unable to follow protocol requirements, including obligatory biopsies;\n* any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drugs;\n* any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigator's judgment, contraindicate patient participation in the clinical trial or compromise compliance with the protocol.","ALL","18 Years",{"count":167,"type":168},126,"ESTIMATED","INTERVENTIONAL",[171],"PHASE2","CAREGIVER is a prospective, randomized, multicenter, open, five-arm study with unequal allocation ratios of 1:1:2:1:2 (palbociclib : paclitaxel : palbociclib + paclitaxel : carboplatin : carboplatin + paclitaxel). Study will be performed in untreated patients with triple-negative breast cancer (TNBC). Potential candidates without previously established diagnosis of TNBC will be included in a Pre-screening Phase, when a biopsy of breast tumor will be taken to confirm the diagnosis of cancer, select patients with TNBC and collect tissue for translational research.",[174],"Triple Negative Breast Neoplasms","NOT_YET_RECRUITING","2021-10-04",{"date":178,"type":179},"2021-10-05","ACTUAL",{"date":181,"type":168},"2022-01-01",{"date":183,"type":168},"2026-12-06",{"name":5,"class":6},6]