[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527679":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":51,"centralContacts":58,"locations":67,"responsibleParty":96,"collaborators":98,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":102,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":35,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":70,"whyStopped":35,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Jules Bordet Institute","OTHER",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"No pre-operative treatment","EXPERIMENTAL","Control group: Standard of care\n\nNumber of subjects: 28 (14 lean patients, defined as Body mass index \\\u003C25 kg\u002Fm², and 14 overweight\u002Fobese patients, defined as BMI ≥25 kg\u002Fm² )",[13,14],"Procedure: Prospective data and sample collection","Drug: Omeprazole 20mg Capsule",{"label":16,"type":10,"description":17,"interventionNames":18},"Pre-operative ketorolac","Investigational Medicinal Product (IMP): Ketorolac\n\nNumber of subjects: 28 (14 lean patients, defined as Body mass index \\\u003C25 kg\u002Fm², and 14 overweight\u002Fobese patients, defined as BMI ≥25 kg\u002Fm² )",[13,19,14],"Drug: Ketorolac 10 Mg Oral Tablet",{"label":21,"type":10,"description":22,"interventionNames":23},"Pre-operative pregabalin","Investigational Medicinal Product (IMP): Pregabalin\n\nNumber of subjects: 28 (14 lean patients, defined as Body mass index \\\u003C25 kg\u002Fm², and 14 overweight\u002Fobese patients, defined as BMI ≥25 kg\u002Fm² )",[13,24,14],"Drug: Pregabalin 75mg",{"label":26,"type":10,"description":27,"interventionNames":28},"Pre-operative ketorolac and pregabalin","Investigational Medicinal Products (IMPs): Ketorolac and pregabalin\n\nNumber of subjects: 28 (14 lean patients, defined as Body mass index \\\u003C25 kg\u002Fm², and 14 overweight\u002Fobese patients, defined as BMI ≥25 kg\u002Fm² )",[13,19,24,14],[30,36,41,45],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"PROCEDURE","Prospective data and sample collection","Core-needle biopsy of the breast (pre-treatment), surgical sample collection (post-treatment), extra collection of blood samples (pre- and post-treatment), measurements of adiposity, lifestyle questionaire",[9,16,26,21],null,{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":35},"DRUG","Ketorolac 10 Mg Oral Tablet","Patients will receive 10 mg film-coated tablets of ketorolac tromethamine three times a day, for five days before the surgery",[16,26],{"type":37,"name":42,"description":43,"armGroupLabels":44,"otherNames":35},"Pregabalin 75mg","Patients will receive 75 mg of pregabalin hard capsule twice a day, for seven days before the surgery",[26,21],{"type":37,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Omeprazole 20mg Capsule","Patients will receive 20 mg of omeprazole once a day on an empty stomach, for five days before the surgery",[9,16,26,21],[50],"Auxiliary medicinal product",[52,56],{"name":53,"affiliation":54,"role":55},"Christine Desmedt, PhD","KU Leuven","STUDY_CHAIR",{"name":57,"affiliation":5,"role":55},"Imane Bachir, MD",[59,63],{"name":57,"role":60,"phone":61,"phoneExt":35,"email":62},"CONTACT","+3225413601","imane.bachir@bordet.be",{"name":64,"role":60,"phone":65,"phoneExt":35,"email":66},"Marion Maetens, PhD","+3216321194","marion.maetens@kuleuven.be",[68],{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Institut Jules Bordet","RECRUITING","Brussels","Brussels Capital","1170","Belgium","BE",{"type":77,"coordinates":78},"Point",[79,80],4.34878,50.85045,{"lat":80,"lon":79},[83,87,91,94],{"name":57,"role":60,"phone":84,"phoneExt":85,"email":86},"+322541","3601","imane.bachir@hubruxelles.be",{"name":88,"role":60,"phone":84,"phoneExt":89,"email":90},"Sophie Vankerkhove","7341","sophie.vankerckhove@hubruxelles.be",{"name":92,"role":93,"phone":35,"phoneExt":35,"email":35},"Florin Pop, MD","PRINCIPAL_INVESTIGATOR",{"name":57,"role":95,"phone":35,"phoneExt":35,"email":35},"SUB_INVESTIGATOR",{"type":97,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[99],{"name":54,"class":6},"100527679","phase-2-ketorolac-and-pregabalin-effects-on-breast-cancer-keprest-100527679",false,"NCT06150898","Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)","Unravelling the Local and Systemic Effects of Primary Surgery and Perioperative Use of Ketorolac and Pregabalin in Primary Breast Cancer Patients According to Adiposity","KePreSt","Inclusion Criteria:\n\nSubjects must meet all of the following criteria in order to be eligible for this study:\n\n1. Age ≥ 18 years and ≤ 70 years old\n2. Female\n3. Weight ≥ 35 kg\n4. Histological diagnosis of invasive breast adenocarcinoma that is estrogen receptor positive as per the updated American Society of Clinical Oncology (ASCO) - College of American Pathologists (CAP) guidelines according to local testing with ER-positive is defined as having an immunohistochemistry (IHC) of 1% or more and\u002For Allred score of 3 or more\n5. Tumour size ≥ 1.5 cm, determined by diagnostic ultrasound or MRI\u002FCT scan.\n6. Stage I, II or III disease (non-metastatic)\n7. In case of multifocal, multicentric unilateral or bilateral breast: Adenocarcinoma tumours are allowed provided that all foci are ER+ according to local testing\n8. Subject scheduled for a primary breast cancer surgery\n9. Subject is willing to provide plasma\u002Fblood and tumour samples for translational research.\n10. Subject is willing to provide tissue from a newly obtained core or excisional biopsy of the tumour that should be evaluable for central histological characterization and future molecular testing\n11. Subject is willing to take omeprazole and has no contraindication to omeprazole.\n12. Have an HEMSTOP score\\\u003C2 and conventional coagulation screening test within normal limits such as activated partial thromboplastin time (21.6\\\u003C aPTT \\>28.7), international normalised ratio (1.31\\\u003CINR) and platelet count (\\>100.10³\u002Fml)\n13. Women of childbearing potential must agree to use of one highly effective method of contraception prior study entry, during the course of the study and at least one months after the last administration of study treatment.\n14. Negative serum pregnancy test for women of childbearing potential (within 30 days before start of treatment)\n15. Subject is willing and able to provide written informed consent for the trial\n\nExclusion Criteria:\n\nSubjects meeting one of the following criteria are not eligible for this study:\n\n1. Subject planned for intraoperative radiotherapy\n2. Subject planned for immediate reconstruction\n3. Neoadjuvant BC therapy\n4. Allergy to any NSAID or gabapentinoïd\n5. Known hypersensitivity reactions to the investigational treatments, or any excipients or auxiliary medicinal products or concomitant medications. Hypersensitive to peanut or soya (related to propofol contraindications)\n6. Current use of the antidiabetic agent thiazolidinedione (related to interaction with pregabalin), lithium salts, probenecid, pentoxifylline or intensive diuretic therapy.\n7. Current NSAID (\\> twice a week the year prior to diagnosis) or pregabalin use\n8. Previous malignant pathology within 5 years prior to inclusion or currently undergoing maintenance therapy. Exceptions include basal cell carcinoma or squamous cell carcinoma of the skin that have undergone potentially curative therapy or in situ cervical cancer.\n9. Active or history of peptic ulcer disease or gastro-intestinal bleeding or perforation\n10. Pregnancy or lactating women\n11. Chronic inflammatory disease as rheumatoid arthritis, uncontrolled asthma, chronic heart failure, chronic obstructive pulmonary disease, cystic fibrosis, inflammatory myopathies (e.g., idiopathic polymyositis, dermatomyositis, inclusion body myositis), inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), McArdle's disease, multiple sclerosis, lupus, chronic inflammatory demyelinating polyneuropathy, psoriasis, autoimmune thyroiditis as Graves' disease or Hashimoto's thyroiditis (unless previous surgical ablation), myasthenia gravis, vasculitis.\n12. Complete or partial nasal polyposis syndrome, Quincke's oedema, bronchospasm, asthma\n13. Known chronic infectious disease as active hepatitis B (defined as positive serology for Ac anti-HBc and IgM anti HBc OR Ac anti HBc and Ag HBs), active hepatitis C (defined as positive serology for anti-VHC and positive PCR-VHC) or active tuberculosis (included under treatment)\n14. Uncontrolled HIV infection (defined as detectable viral loads by standard clinical assays) or controlled HIV infection (defined undetectable HIV viral loads by standard clinical assays) treated by one of following drugs: Nelfinavir, Atazanavir or Saquinavir (related to interaction with omeprazole).\n15. Infection currently treated with one of the following drugs: posaconazole, voriconazole, ketoconazole and rifampicin, unless discontinuation of treatment is planned at least 10 days prior to the start of study treatment AND with complete resolution according to expert opinion (related to interaction with omeprazole)\n16. Inadequate liver function (defined as total serum bilirubin ≥ 2 x upper limit of normal (ULN\\\u003C1.2 mg\u002Fdl) - unless documented Gilbert syndrome- AND Alanine Aminotransferase (ALT) ≥ 2 x ULN (ULN \\\u003C32 UI\u002Fl and ULN \\\u003C33 UI\u002Fl, respectively) AND Alkaline phosphatase (ALP) ≥ 2.5 x ULN (ULN=104 UI\u002Fl))\n17. Cirrhosis or severe hepatitis.\n18. Renal impairment (defined as GFR\\\u003C90ml\u002Fmin\u002F1.73m² or serum creatinine \\> 442 μmol\u002Fl or \\> 5 mg\u002FdL) or single kidney or previous renal surgery\n19. Subject with history of (severe) renal toxicity with an NSAID\n20. Subject with a recent history of operations associated with a high risk of bleeding\n21. Previous, ongoing or suspected cardiovascular disease defined as history of ischemic heart disease or heart failure or uncontrolled high blood pressure (Systolic ≥160mmHg and\u002For diastolic ≥100mmHg) or peripheral arterial disease or cerebrovascular disease\n22. Subject with a recent history of surgery associated with a high risk of bleeding\n23. Hemostasis disorder as haemophilia, Von Willebrand disease, constitutional thrombopathies or thrombocytopenia (defined as platelet count \\\u003C 100 000\u002Fmm³), current \u002Fplanned anticoagulant or anti-platelet therapy.\n24. Inadequate bone marrow function (defined as absolute neutrophil count \\\u003C1000\u002FμL and platelet count \\\u003C100'000\u002FμL)\n25. Systemic immunosuppressive treatment (defined as systemic corticotherapy or anti-rejection treatment or interferon therapy) within the 2-years prior diagnosis\n26. Psychiatric disease or antipsychotic\u002F antidepressant use\n27. Epilepsy or any current anti-epileptic drug use\n28. Obstructive sleep apnea\n29. ASA≥3","FEMALE","18 Years","70 Years",{"count":112,"type":113},112,"ESTIMATED","INTERVENTIONAL",[116],"PHASE2","Out of all proportion to its short duration, the perioperative period is critical in determining the long-term outcome of cancer.\n\nTo contribute to a better understanding of the neural and inflammatory mechanisms underlying this issue, we aim to implement a novel intervention based on the preoperative use of non-steroidal anti-inflammatory drugs (NSAIDs) with or without an anti-epileptic drug.\n\nOur goal is to understand and transform the perioperative window from being a facilitator of metastatic progression to arresting and\u002For eliminating residual disease using repurposing drugs",[119,120],"Early-stage Breast Cancer","Estrogen-receptor-positive Breast Cancer",[122,123,124,125,126,127,128,129,130],"Surgery","Inflammation","Breast cancer","Neuronal features","Ketorolac","Pregabalin","Adiposity","Neurotransmitter","Nerves","2025-06-10",{"date":133,"type":134},"2025-06-13","ACTUAL",{"date":136,"type":134},"2025-05-12",{"date":138,"type":113},"2027-10",{"name":5,"class":6},1]