[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brca-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brca-mutation":38},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,55,89,113,147,175,200,220,251,280,307,333,354,393],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":39,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":4},"100054125","quality-of-life-of-patients-who-have-undergone-bilateral-mastectomy-100054125",false,"NCT07699913","Quality of Life of Patients Who Have Undergone Bilateral Mastectomy","Psychological Experience, Quality of Life, and Patient Satisfaction Following Bilateral Breast Reconstruction After Prophylactic or Therapeutic Mastectomy, Using the BREAST-Q Questionnaire.","RM BREAST Q","Inclusion Criteria:\n\n* Female sex\n* Age ≥ 18 years\n* Bilateral mastectomy\n* Breast reconstruction between January 1, 2015, and January 1, 2026\n* No objection to the study\n\nExclusion Criteria:\n\n* Individual under guardianship or curatorship, or deprived of liberty\n* Reconstruction not completed by January 1, 2026.","FEMALE","18 Years",{"count":20,"type":21},115,"ESTIMATED","OBSERVATIONAL","We therefore aim to determine whether the type of mastectomy (preventive in a high-risk patient or therapeutic in a patient with a history of cancer), as well as the timing (immediate or delayed) and type of breast reconstruction, influence the quality of life and satisfaction of patients who have undergone bilateral mastectomy. The goal of this observational study is thus to measure and compare the quality of life of patients who have undergone bilateral mastectomy using the BREAST-Q questionnaire.",[25,26,27,28,29,30,31,32,33,34,35,36,37,38],"Surgery Date","Age","BMI","Height","Weight","Smoking Status","Hormone Therapy","Chemotherapy","Radiotherapy","Postoperative Complications","Type of Reconstruction (Flap or Implant)","Timing of Reconstruction","Type of Mastectomy (Prophylactic or Therapeutic)","BRCA Mutation",[40,41,42],"Comparative","observational","retrospective","NOT_YET_RECRUITING","2026-07-07",{"date":46,"type":47},"2026-07-13","ACTUAL",{"date":49,"type":21},"2026-07-10",{"date":51,"type":21},"2026-08-20",{"name":53,"class":54},"University Hospital, Grenoble","OTHER",{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":62,"minAge":18,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":75,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100529699","phase-1-olaparib-and-astx727-in-brca12--and-homologous-recombination-deficient-hrd-mutated-tumors-100529699","NCT06177171","Olaparib and ASTX727 in BRCA1\u002F2- and Homologous Recombination Deficient (HRD)-Mutated Tumors","A Phase I\u002FIb Study of Olaparib and ASTX727 in BRCA1\u002F2- and HRD-mutated Tumors","Inclusion Criteria:\n\n1. Participants must have histologically or cytologically confirmed advanced solid tumors (any solid tumor type) with:\n\n   Phase I, Dose Escalation: Germline and\u002For somatic mutation\\* in one or more of the following genes: BRCA1, BRCA2, PALB2, ATM, and\u002For CHEK2.\n\n   Phase Ib, Dose Expansion\\*\\*:\n   1. Expansion Cohort A (n=6): Germline mutation\\* (with or without accompanying somatic mutation) in one or more of the following genes: BRCA1, BRCA2, PALB2, ATM, and\u002For CHEK2;\n   2. Expansion Cohort B (n=6): Germline and\u002For somatic mutation\\* in one or more of the following genes: BRCA1, BRCA2, PALB2, ATM, and\u002For CHEK2.\n\n      * Testing for DNA repair mutations should occur prior to study consent or enrollment via a CLIA-approved test.\n2. Has measurable disease per RECIST 1.1 as assessed by the investigator. Lesions situated in previously irradiated areas are considered measurable if progression has been demonstrated in such lesions.\n3. Participants may have received any lines of prior therapy and is refractory or intolerant to therapy approved for their condition or unwilling to receive currently approved therapy.\n4. Prior PARP inhibitors are allowed, provided the following two criteria are met:\n\n   1. Participant has NOT required toxicity related dose reductions or dose delays during prior PARP inhibitor treatment; and\n   2. Participant has NOT experienced any allergic reaction to PARP inhibitors.\n5. Age \\>=18 years\n6. Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C2, or Karnofsky \\>60%\n7. Demonstrates adequate organ function as defined below:\n\n   Adequate bone marrow function:\n   1. hemoglobin \\>=10.0 g\u002Fdl\n   2. absolute neutrophil count \\>=1,500\u002Fmicroliter (mcL)\n   3. platelets \\>=100,000\u002FmcL\n\n   Adequate hepatic function:\n   1. total bilirubin ≤ 1.5 x institutional upper limit normal (ULN)\n   2. aspartate aminotransferase (AST)\u002F(SGOT) \\\u003C= 2.5 x institutional ULN\n   3. alanine aminotransferase (ALT)\u002F(SGPT) \\\u003C= 2.5 x institutional ULN\n   4. creatinine \\\u003C= 1.5 x institutional ULN or creatinine clearance Glomerular filtration rate (GFR) \\>= 50 mL\u002Fmin\u002F1.73 m\\^2, calculated using the Cockcroft-Gault equation.\n8. Ability to understand and the willingness to sign a written informed consent document.\n9. Human immunodeficiency virus (HIV)-infected individuals on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n10. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n11. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. Individuals with HCV infection who are currently on treatment could be eligible if HCV viral load is undetectable.\n12. Individuals with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for at least 4 weeks. Participants need to be without requirement for steroid treatment for at least 14 days prior to the first dose of study intervention. A participant with one or two lesions that have been definitely treated with resection or focal radiation and has no symptoms is eligible after 2 weeks.\n13. Based on findings from human data and\u002For animal studies, and their mechanisms of action, ASTX727 and olaparib can cause fetal harm when administered to a pregnant woman. For this reason, females of child-bearing potential (defined below) must agree to use adequate contraception including hormonal or barrier methods or strict abstinence for the duration of study treatment and for 6 months after last administration of study treatment. Males (with female partners of reproductive potential or who are pregnant) treated or enrolled on this protocol also must agree to use adequate contraception for the duration of study treatment, and for 3 months after last administration of study treatment. Should an individual participating in this study (or the partner of an individual participating in the study) become pregnant or suspect pregnancy, they should inform the treating physician immediately. A female is considered to be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), unless it is documented that the individual meets either of the following two criteria: (1) has reached a postmenopausal state (\\>= 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries).\n14. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\nNote: Diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) are excluded per Exclusion # 7.\n\nExclusion Criteria:\n\n1. Has received systemic anticancer therapies within 3 weeks of first dose, radiation within 2 weeks, antibody therapy within 4 weeks. Concomitant administration of Luteinizing hormone-releasing hormone (LHRH) analogues for prostate cancer and somatostatin analogues for neuroendocrine tumors are allowed as per standard of care.\n2. Has not recovered from adverse events due to prior anti-cancer therapy to \\\u003C= grade 1 (CTCAE v5.0) or baseline (other than alopecia).\n3. Receipt of any other investigational agents or devices within 3 weeks prior to initiation of trial therapy.\n4. Unable to swallow oral medications\n5. Individuals who are breast-feeding\u002Fchest-feeding (because of the potential for serious adverse reactions in breastfeed infants from olaparib and ASTX727). Study participants who are lactating must agree to discontinue breast-feeding\u002Fchest-feeding for the duration of study treatment and for 1 month after the final dose of trial therapy.\n6. Individuals who are pregnant (because of the potential for olaparib and ASTX727 to cause serious adverse reactions to the unborn child). Females of childbearing potential (defined below) must have a negative urine or serum pregnancy test within 72 hours prior to first administration of study drug. A female is considered to be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), unless it is documented that the individual meets either of the following two criteria: (1) has reached a postmenopausal state (\\>= 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries). Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study activities, interfere with participant safety, or study endpoints.\n7. Diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).\n8. Taking a prohibited medication that cannot be safely discontinued or substituted.","ALL",{"count":64,"type":21},18,"INTERVENTIONAL",[67],"PHASE1","This is a single center, phase I\u002FIb clinical trial evaluating the combination of the poly adenosine diphosphate-ribose polymerase (PARP) inhibitor olaparib with the DNA methyltransferase (DNMT) inhibitor ASTX727, which is an oral formulation of decitabine with cedazuridine (a cytidine deaminase inhibitor that allows for oral administration). The study population consists of adults with advanced\u002Fmetastatic solid tumor malignancies with germline or somatic mutations in the HRR pathway (i.e., BReast CAncer gene 1 (BRCA1), BReast CAncer gene 2(BRCA2), Partner And Localizer of BRCA2 (PALB2), ATM, and\u002For Checkpoint kinase 2 (CHEK2) mutations).",[70,71,38,72,73,74],"BRCA1 Mutation","BRCA2 Mutation","PALB2 Gene Mutation","Checkpoint Kinase 2 Gene Mutation","ATM Gene Mutation",[76,77],"Homologous Recombination Deficiency","HRR Pathway","RECRUITING","2026-05-22",{"date":81,"type":47},"2026-05-27",{"date":83,"type":47},"2024-02-07",{"date":85,"type":21},"2028-01-31",{"name":87,"class":54},"Varun Monga, MBBS",1,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":88},"100498381","prediction-of-germline-brca-12-genes-from-healthy-ovaries-100498381","NCT05769517","Prediction of Germline BRCA 1\u002F2 Genes From Healthy Ovaries","Prediction of Germline BRCA 1\u002F2 Genes Pathogenetic Variants From Healthy Ovaries Ultrasound Images: Radiogenomics as an Innovative Tool to Prevent BRCA-related Cancers","PROBE-II","Inclusion Criteria:\n\nAvailability of gBRCA1\u002F2 test results\n\nTransvaginal pelvic US performed providing at least one picture of one healthy ovary\n\nUS images stored in .dicom format.\n\nExclusion Criteria:\n\nPersonal diagnosis of OC\n\nOvarian abnormal findings (eg. ovarian endometriomas, dermoid cyst, ovarian cystoadenofibroma, ovarian borderline tumour…) with the exception of functional cysts at pelvic US\n\ngBRCA1\u002F2 testing results nor provided by an ISO 1589 accredited laboratory\n\nRefusal to provide written informed consent",true,{"count":99,"type":21},6465,"The project aims at enhancing performance metrics and prospectively validating a radiogenomics model based on ovarian US images for predicting germline breast cancer susceptibility gene 1 and\u002For 2 (BRCA) status in women with healthy ovaries. The project is divided in two operational phases:\n\nModel development phase (ambispective)\n\nAIM 1: To define and implement a proper and fine-tuned image preprocessing pipeline on the existing dataset; AIM 2: To enlarge dataset size with new real images from different centers and apply data augmentation techniques, deep neural network models combined with the aforementioned handcrafted imaging features from radiomics analysis;\n\nImplementation and validation phase (prospective)\n\nAIM 3: To further cross-validate the predictive model on US images acquired prospectively in an observational multicenter study.",[38,102,103],"Ovarian Cancer","Ultrasound Therapy; Complications","2026-04-21",{"date":106,"type":47},"2026-04-24",{"date":108,"type":47},"2023-03-20",{"date":110,"type":21},"2031-03-08",{"name":112,"class":54},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":62,"minAge":18,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":65,"phases":122,"briefSummary":124,"conditions":125,"keywords":135,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":5},"100546483","phase-1-a-study-of-parg-inhibitor-etx-19477-in-patients-with-advanced-solid-malignancies-100546483","NCT06395519","A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies","ERADIC8","Inclusion Criteria:\n\n* Males and females of age ≥ 18 years at the time of signing the informed consent document.\n* Histologically or cytologically confirmed advanced (incurable recurrent, unresectable, or metastatic) solid cancer, excluding primary central nervous system (CNS) tumors.\n* Any solid tumor malignancy, excluding primary CNS tumors, with progression on or after or intolerance to most recent systemic therapy. Preferential enrollment consideration will be made for patients with known BRCA2 mutations resulting in loss of function.\n* Measurable disease per RECIST v1.1.\n* ECOG performance status 0-1.\n* Progression on or after or intolerance to most recent systemic therapy. Prior treatment in the recurrent\u002Fmetastatic setting; patients must have received approved standard therapy that is available to the patient that is known to confer clinical benefit, unless this therapy is contraindicated, intolerable to the patient, or is declined by the patient.\n* No investigational agent within 3 weeks or 5 half-lives (whichever is shorter; minimum of 2 weeks) prior to first dose of study drug.\n* Life expectancy of at least 3 months.\n\nExclusion Criteria:\n\n* Receiving continuous corticosteroids at prednisone-equivalent dose of \\>10 mg\u002Fday. Chronic systemic corticosteroid therapy for physiologic replacement (≤10 mg\u002Fday of prednisone equivalents) and the use of non-systemic corticosteroids (e.g., inhaled, topical, intra-nasal, intra-articular, or ophthalmic) are permitted.\n* Definitive radiotherapy within 6 weeks and palliative radiation within 2 weeks prior to the first dose of study drug.\n* Symptomatic untreated or progressing brain metastases. Stable, treated brain metastases are allowed if no evidence of radiologic or clinical progression or increasing corticosteroid use for at least 4 weeks.\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of ETX-19477 and no history of bowel obstruction within 6 months and\u002For peritoneal fluid drainage within 8 weeks prior to the first dose of study drug.\n* Known symptomatic and radiologically progressing or leptomeningeal disease (LMD). If LMD has been reported radiographically on baseline magnetic resonance imaging (MRI), but is not suspected clinically by the Investigator, the patient must be free of neurological symptoms of LMD.\n* Resting ECG with QT interval calculated using the Fridericia's formula (QTcF) \\>470 msec on 2 or more timepoints within a 24-hour period, or history or family history of congenital long QT syndrome, or taking concomitant medications that are known to prolong the QT\u002FQTc interval, or history of additional risk factors for torsades de pointes (Tdp).\n* History of myocardial infarction or unstable angina within 6 months prior to enrollment, or clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension, clinically significant uncontrolled arrhythmias, or any history of symptomatic congestive heart failure.\n* Known active or chronic infection (viral, bacterial, or fungal), including tuberculosis, hepatitis B, hepatitis C, or AIDS-related illness. Controlled infections, including HIV and \"cured\" hepatitis C (no active fever, no evidence of systemic inflammatory response syndrome) that are stable with undetectable viral load on antiviral treatment are not exclusionary.\n* Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease (with exception of patients with Gilbert's Syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per Investigator assessment).\n* Known other previous\u002Fcurrent malignancy requiring treatment within ≤2 years except for limited disease treated with curative intent, such as carcinoma in situ, squamous or basal cell skin carcinoma, or superficial bladder carcinoma and not requiring ongoing chemotherapy.\n* Patients receiving proton pump inhibitors (PPIs), strong cytochrome P450 (CYP)3A inhibitors and inducers, or P-glycoprotein (P-gp) inhibitors. Patients should not receive PPIs within 7 days prior to first dose of study drug. Strong CYP3A inducers or inhibitors or strong P-gp inhibitors should not be given within 6 half-lives prior to first dose of study drug.\n* Patients currently treated with therapeutic doses of warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants",{"count":121,"type":21},120,[67,123],"PHASE2","This is a two-part, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and anti- tumor activity of ETX-19477, a novel reversible small molecule inhibitor of PARG.",[126,127,102,128,129,71,130,131,70,38,132,133,134],"Advanced or Metastatic Solid Tumors","Breast Cancer","Prostate Cancer","Epithelial Ovarian Cancer","ER+ Breast Cancer","Castrate Resistant Prostate Cancer","Endometrial Cancer","Colorectal Cancer","Gastric Cancer",[136],"PARG Inhibitor","2026-03-24",{"date":139,"type":47},"2026-03-27",{"date":141,"type":47},"2024-05-13",{"date":143,"type":21},"2026-12",{"name":145,"class":146},"858 Therapeutics, Inc.","INDUSTRY",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":155,"minAge":18,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":158,"conditions":159,"keywords":163,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":88},"100446733","the-genpet-study---an-imaging-study-of-fch-pet-ct-in-men-with-prostate-cancer-and-a-dna-repair-gene-mutation-100446733","NCT05097274","The GENPET Study - An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation.","An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation (GENPET)","GENPET","Inclusion Criteria:\n\n* Confirmed pathogenic germline mutation in any of the following genes BRCA1, BRCA2, MSH2, MSH6, MLH1, PMS2, CHEK2, PALB2 or ATM.\n* Over the age of 18\n* Diagnosed with prostate cancer and at a time when staging imaging is clinically indicated; either:\n\n  * At a new diagnosis\n  * Biochemically progressing patients who were treated radically with surgery or radiotherapy (more than 6 months ago) and are currently not receiving hormonal treatment or chemotherapy\n  * Patients on active surveillance with a PSA doubling time of 6 months or less\n\nExclusion Criteria:\n\n* Diagnosis of other malignancy (excluding basal cell cancer\u002Fsquamous cell cancer of the skin) within five years of diagnosis\n* Known metastatic prostate cancer, both local and distant\n* Patients who have received any oncological treatment within the last six months\n* Patients on any investigational drug treatment\n* Patients on steroids\n* Known history of inflammatory\u002Finfective diseases (e.g. sarcoidosis, tuberculosis, inflammatory bowel disease)\n* Contraindications to having an MRI using the standard MRI checklist (e.g. pacemakers, aneurysm clips, claustrophobia)","MALE",{"count":157,"type":21},50,"The aim of the study is to determine if PET-CT imaging (using contrast recommended in clinical guidelines) is superior to combined bone scan and MRI\u002FCT of the abdomen \\& pelvis in detecting the increased incidence of metastasis (nodal\u002Fdistant outside the pelvis) in men with prostatic carcinoma with mutations in any of the following germline DNA repair genes BRCA1, BRCA2, MSH2, MSH6, MLH1, PMS2, CHEK2, PALB2, ATM.",[128,38,160,74,161,162,72],"Mismatch Repair Gene Mutation","HOXB13 Germline Mutation","CHEK2 Gene Mutation",[164,165],"FCH-PET-CT","PSMA-PET-CT","2025-12-08",{"date":168,"type":47},"2025-12-16",{"date":170,"type":47},"2015-10-15",{"date":172,"type":21},"2032-12-31",{"name":174,"class":54},"Institute of Cancer Research, United Kingdom",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":62,"minAge":18,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":65,"phases":184,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":199},"100599753","phase-1-study-of-syn608-for-the-treatment-of-advanced-or-metastatic-solid-tumors-100599753","NCT07088588","Study of SYN608 for the Treatment of Advanced or Metastatic Solid Tumors","A First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SYN608, a Poly ADP-ribose Glycohydrolase (PARG) Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Having signed the written Informed Consent Form (ICF);\n* Male or female aged ≥18 years;\n* Life expectancy ≥12 weeks;\n* Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1;\n* Patients with histologically or cytologically confirmed locally advanced or metastatic breast cancer, ovarian cancer or other advanced solid tumors who have experienced disease progression, and available standard of care (SOC) therapies had been exhausted;\n* be willing to provide tumor tissue samples (fresh frozen \\[SF\\] or previously retained paraffin-embedded \\[FFPE\\] tumor tissue samples) or peripheral blood germline DNA or ctDNA sample to detect BRCA mutation, or other deficiency in the Homologous Recombination (HR) pathway (by the detection method of next generation sequencing \\[NGS\\])\n* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;\n* No serious hematological, cardiopulmonary, or liver or kidney diseases other than the primary disease;\n* Adequate organ function and bone marrow function.\n\nExclusion Criteria:\n\n* Previous or current use of Poly (ADP) ribose glycohydrolase (PARG) inhibitors;\n* Serious allergy to the study drug or any of its excipients;\n* Current or previous other malignancy unless treated radically and with no evidence of recurrence or metastasis within the past 5 years;\n* Central nervous system (CNS) metastasis or meningeal metastasis with clinical symptoms, or other evidence indicating that CNS metastasis or meningeal metastasis has not been adequately controlled;\n* Patients with Myelodysplastic syndrome (MDS)\u002FAcute myeloid leukemia (AML) or with features suggestive of MDS\u002FAML;\n* Dysphagia or refractory nausea and vomiting, malabsorption, extracorporeal biliary shunts, or gastrointestinal disorders that affect drug absorption, e.g., Crohn's disease, ulcerative colitis, or short bowel syndrome, or other malabsorption conditions;\n* Treatment with an anti-cancer small molecule within 5 half-lives (t1\u002F2), or 2 weeks, whichever is shorter;\n* History of use within 2 weeks prior to the first dose of the study treatment and need to use protocol-prohibited potent inhibitors or potent inducers of cytochrome P450 (CYP) 3A4\u002FBCRP\u002FP-gp during the study;\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease;\n* Serious systemic diseases or laboratory abnormalities or other conditions that, at the Investigator's discretion, will make it unsuitable for the patient to participate in this clinical trial.",{"count":183,"type":21},105,[67],"This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN608 as monotherapy in adult patients with advanced solid tumors",[187,188,102,127,38,189],"Advanced Solid Cancer","Metastatic Solid Tumor","HRR Deficiency","2025-07-25",{"date":192,"type":47},"2025-07-28",{"date":194,"type":21},"2025-07-31",{"date":196,"type":21},"2028-10-31",{"name":198,"class":146},"Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd",2,{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":62,"minAge":18,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":65,"phases":209,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":199},"100567290","phase-1-study-of-syn818-for-the-treatment-of-advanced-or-metastatic-solid-tumors-100567290","NCT06666270","Study of SYN818 for the Treatment of Advanced or Metastatic Solid Tumors","A First-in-human, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumor Activity of SYN818, a DNA Polymerase Theta (POLQ) Inhibitor Alone in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Having signed the written Informed Consent Form (ICF);\n* Male or female aged ≥18 years;\n* Life expectancy ≥12 weeks;\n* Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1;\n* Patients with histologically or cytologically confirmed locally advanced or metastatic breast cancer, ovarian cancer, prostate cancer or other advanced solid tumors who have experienced disease progression, and available SOC therapies had been exhausted;\n* be willing to provide tumor tissue samples (fresh frozen \\[SF\\] or previously retained paraffin-embedded \\[FFPE\\] tumor tissue samples) or peripheral blood germline DNA or ctDNA sample to detect BRCA mutation, or other deficiency in the HR pathway (by the detection method of next generation sequencing \\[NGS\\])\n* At least one measurable lesion according to RECIST v1.1;\n* No serious hematological, cardiopulmonary, or liver or kidney diseases other than the primary disease;\n* Adequate organ function and bone marrow function.\n\nExclusion Criteria:\n\n* Previous or current use of POLQ inhibitors;\n* Hypersensitivity to the active pharmaceutical ingredient or any excipient of SYN818;\n* Central nervous system (CNS) metastasis or meningeal metastasis with clinical symptoms, or other evidence indicating that CNS metastasis or meningeal metastasis has not been adequately controlled;\n* Other malignant tumors than the study tumors within 5 years prior to the first dose of the study drug, except for localized cancers that have been evidently cured or disease-free for at least 3 years, such as basal or squamous cell skin cancer, superficial bladder cancer, prostate carcinoma in situ, carcinoma in situ of cervix, or carcinoma in situ of breast;\n* Patients with Myelodysplastic syndrome (MDS)\u002FAcute myeloid leukemia (AML) or with features suggestive of MDS\u002FAML;\n* Dysphagia or refractory nausea and vomiting, malabsorption, extracorporeal biliary shunts, or gastrointestinal disorders that affect drug absorption, e.g., Crohn's disease, ulcerative colitis, or short bowel syndrome, or other malabsorption conditions;\n* Major surgery or serious trauma within 4 weeks prior to the first dose of the study treatment or major surgery planned during the trial period, and none of the AEs related to surgery or major trauma have resolved (to ≤ CTCAE v5.0 Grade 1 or baseline level) before the first dose of the study drug;\n* History of use within 2 weeks prior to the first dose of the study treatment and need to use protocol-prohibited potent inhibitors or potent inducers of cytochrome P450 (CYP) 3A4\u002FBCRP\u002FP-gp during the study;\n* Serious systemic diseases or laboratory abnormalities or other conditions that, at the Investigator's discretion, will make it unsuitable for the patient to participate in this clinical trial.",{"count":208,"type":21},30,[67],"This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN818 as monotherapy in adult patients with advanced solid tumors",[187,188,102,127,128,38,189],"2025-07-18",{"date":214,"type":47},"2025-07-20",{"date":216,"type":47},"2024-11-21",{"date":218,"type":21},"2026-12-30",{"name":198,"class":146},{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":97,"sex":17,"minAge":228,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":231,"conditions":232,"keywords":237,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":88},"100577009","measurement-of-circulating-mutation-burden-100577009","NCT06792721","MEASUREMENT OF CIRCULATING MUTATION BURDEN","EVALUATION OF CANCER RISK BY MEASUREMENT OF CIRCULATING MUTATIONAL BURDEN IN CARRIERS OF A GENETIC PREDISPOSITION","cRISK","Inclusion Criteria:\n\n* Female participant\n* Participant undergoing oncogenetic follow-up at the Centre François Baclesse\n* Participant belonging to a pair of related biological siblings\n* Within the sibling pair, one participant is a carrier of a hereditary predisposition linked to a BRCA1\u002F2 mutation (case), and the other participant is not a carrier (control).\n* Participant between 30 and 50 years of age\n* Participant affiliated to a social security scheme\n* Participant having given her consent to participate by signing an informed consent form prior to any specific study-related procedure.\n\nExclusion Criteria:\n\n\\-","30 Years","50 Years",{"count":208,"type":21},"Cancer-free women with a hereditary predisposition to breast and\u002For ovarian cancer",[233,234,38,235,236],"Breast Carcinoma","Genetic Predisposition to Cancer","cfMB","Mutation Burden",[235,238,239,240,241],"predisposition to cancer","BRCA1","BRCA2","breast cancer","2025-07-07",{"date":244,"type":47},"2025-07-08",{"date":246,"type":47},"2025-07-04",{"date":248,"type":21},"2027-12-30",{"name":250,"class":54},"Centre Francois Baclesse",{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":62,"minAge":18,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":65,"phases":260,"briefSummary":261,"conditions":262,"keywords":267,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":279},"100476579","phase-2-novel-neoadjuvant-and-adjuvant-strategy-for-germline-brca-12-mutated-triple-negative-breast-cancer-100476579","NCT05485766","Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1\u002F2 Mutated Triple Negative Breast Cancer","Neoadjuvant and Adjuvant Olaparib Plus Pembrolizumab Following Platinum Based Chemotherapy Plus Pembrolizumab for Germline BRCA Mutated Triple Negative Breast Cancer (WJOG14020B\u002FOPERETTA)","Inclusion Criteria:\n\n* Male\u002Ffemale subjects who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of invasive breast cancer\n* Have histologically confirmed TNBC, as defined by the most recent ASCO\u002FCAP guidelines.\n* Confirmed germline BRCA 1\u002F2 mutated.\n* Have previously untreated locally advanced non-metastatic (M0) TNBC defined as the following combined primary tumor (T) and regional lymph node (N) staging per AJCC for breast cancer staging criteria version 7 as assessed by the investigator based on radiological and\u002For clinical assessment:\n\n  1. T1c, N1-N2\n  2. T2, N0-N2\n  3. T3, N0-N2\n  4. T4a-d, N0-N2\n* It has been confirmed that there is no distant metastasis to each organ by the following tests. Chest: Contrast CT or FDG-PET\u002FCT Abdominal: Contract CT\\* or FDG-PET\u002FCT Bone: Bone scintigraphy or FDG-PET\u002FCT Brain: In the case of no central nervous system symptoms, examination for brain metastasis is not required.\n* The subject (or legally acceptable representative if applicable) provides written informed consent for the trial.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Have adequate organ function as defined in the protocol. Specimens must be collected within 10 days prior to the start of study treatment.\n\nExclusion Criteria:\n\n* Subjects who has a positive urine pregnancy test within 72 hours prior to registration\n* Has diagnosed as inflammatory breast cancer.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor .\n* Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n* Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and investigational drugs used in this study and\u002For any of their excipients.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease .\n* Has an active infection requiring systemic therapy.\n* Has a known history of Human Immunodeficiency Virus (HIV) infection.\n* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HbsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n* Has a known history of active TB (Bacillus Tuberculosis).\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding, or expecting to conceive or father children.\n* Has had an allogenic tissue\u002Fsolid organ transplant.\n* Has received pre-treatment with Olaparib or other PARP inhibitors.\n* Has significant cardiovascular disease\n* Has a resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions.\n* Subject has myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML) or with features suggestive of MDS\u002FAML.\n* Subject received colony-stimulating factors within 28 days prior to the first dose of study intervention.\n* Subject is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.\n* Is either unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption.\n* Is, in the judgement of the investigator, unlikely to comply with the study procedures, restrictions, and requirements of the study.\n* Is currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study.\n* Is currently receiving either strong or moderate inducers of CYP3A4 that cannot be discontinued for the duration of the study.",{"count":259,"type":21},23,[123],"This is a Phase II, single-arm, open label study to evaluate Olaparib plus Pembrolizumab following platinum-based chemotherapy plus Pembrolizumab as neoadjuvant therapy for germline BRCA (gBRCA) 1\u002F2 mutated triple negative breast cancer (TNBC).\n\nPembrolizumab in combination with weekly paclitaxel and carboplatin (treatment 1) is followed by Pembrolizumab in combination with Olaparib (treatment 2) in neoadjuvant setting and Pembrolizumab in combination with Olaparib in adjuvant setting will be studied",[263,264,265,127,70,71,38,266],"Triple Negative Breast Neoplasms","Triple Negative Breast Cancer","Breast Neoplasms","BRCA-Associated Breast Carcinoma",[268,269],"BRCA1 protein","BRCA2 protein","2025-03-17",{"date":272,"type":47},"2025-03-20",{"date":274,"type":47},"2024-07-16",{"date":276,"type":21},"2028-09-30",{"name":278,"class":54},"Okayama University",3,{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":62,"minAge":4,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":65,"phases":289,"briefSummary":291,"conditions":292,"keywords":294,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":88},"100582200","robotic-nipple-sparing-mastectomy-with-immediate-reconstruction-100582200","NCT06860217","Robotic Nipple Sparing Mastectomy with Immediate Reconstruction","Robotic Nipple Sparing Mastectomy with Immediate Reconstruction with Prepectoral Implant: a Single Center, Prospective Trial","Inclusion Criteria:\n\n* Candidates to nipple-sparing mastectomy and immediate breast reconstruction for invasive breast cancer, ductal carcinoma in situ (DCIS), BReast CAncer gene (BRCA) mutation carriers\n* Any age\n* Negative preoperative assessment of nipple-areola complex\n* Absence of skin involvement\n* Low probability to have positivity of nipple-areola complex tissue intra-operative frozen section\n* Breast volume ≤ Bra IV\n* No hard smoking (defined as \\\u003C=20 cigarettes\u002Fday)\n* Low and intermediate risk for anesthesia (American Society of Anesthesiologists (ASA) Scale)\n* Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.\n* Patients must be accessible for follow-up\n\nExclusion Criteria:\n\n* Previous thoracic radiation therapy for any reason\n* Inflammatory Breast Cancer\n* Pregnancy\n* Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.\n* Uncompensated Diabetes Mellitus",{"count":288,"type":21},24,[290],"NA","Aim of this trial is to verify whether the patients' quality of life can be improved by a less invasive surgical procedure and whether the use of robotic technique for nipple-sparing mastectomy associated to prepectoral direct implant procedure can impact on perioperative and postoperative period and on oncologic outcome.",[127,293,38],"DCIS",[295,296,297],"Robotic Mastectomy","Nipple-sparing mastectomy","Breast reconstruction","2025-02-28",{"date":300,"type":47},"2025-03-05",{"date":302,"type":21},"2025-04",{"date":304,"type":21},"2032-04",{"name":306,"class":54},"European Institute of Oncology",{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":65,"phases":316,"briefSummary":317,"conditions":318,"keywords":319,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":88},"100580011","minilap-vs-standard-laparoscopy-in-prophylactic-bilateral-salpingo-oophorectomy-in-brca-mutated-patients-100580011","NCT06831747","MiniLap Vs Standard Laparoscopy in Prophylactic Bilateral Salpingo-oophorectomy in BRCA-Mutated Patients","MiniLap Vs Standard Laparoscopy in Prophylactic Bilateral Salpingo-Oophorectomy in BRCA-Mutated Patients: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients undergoing prophylactic bilateral adnexectomy via laparoscopic surgery.\n* Patients with a germline mutation in the BRCA1\u002F2 gene.\n\nExclusion Criteria:\n\n* Patients who underwent additional surgery during the adnexectomy procedure.\n* Patients in whom an intraoperative frozen section is required.",{"count":315,"type":21},80,[290],"The study hypothesis is that surgical treatment performed with MiniLap results in reduced postoperative pain in a population of patients undergoing prophylactic laparoscopic adnexal surgery. The primary objectives are to assess differences in operative duration, intraoperative blood loss, and postoperative complications in patients undergoing bilateral laparoscopic adnexectomy performed with standard laparoscopy versus MiniLap. The secondary objectives of this study are to compare postoperative pain and patient satisfaction with aesthetic outcomes.\n\nPatients with BRCA 1\u002F2 mutations undergoing prophylactic surgery will be assigned to either MiniLap or standard laparoscopic treatment based on randomization. Subsequently, the necessary study data will be collected using the hospital's electronic management system and medical records.",[38],[320,321,322,323],"Laparoscopy","BRCA mutations","Salpingo-Oophorectomy","MiniLap","2025-02-16",{"date":326,"type":47},"2025-02-18",{"date":328,"type":47},"2025-01-08",{"date":330,"type":21},"2025-12",{"name":332,"class":54},"Azienda Sanitaria-Universitaria Integrata di Udine",{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":11,"sex":155,"minAge":4,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":199},"100576271","clinical-outcomes-of-use-of-olaparib-in-castration-resistant-prostate-cancer-100576271","NCT06783127","Clinical Outcomes of Use of Olaparib in Castration Resistant Prostate Cancer","Clinical Outcomes of Use of Olaparib in Castration Resistant Prostate Cancer: An Observational Study","COROS","Inclusion Criteria:\n\nBRCA mutant Metastatic castration-resistant prostate cancer patients treatment with olaparib in clinical practice\n\nExclusion Criteria:\n\nOlaparib treatment in a clinical trial",{"count":342,"type":21},3000,"This is an observational, retrospective\u002Fprospective, multicenter study designed to define, overall survival, clinical outcomes and predictive\u002Fprognostic factors of a consecutive population of mCRPC patients treated with olaparib in clinical practice.",[128,131,38],"2025-02-07",{"date":347,"type":47},"2025-02-11",{"date":349,"type":47},"2023-01-01",{"date":351,"type":21},"2026-12-31",{"name":353,"class":54},"Santa Chiara Hospital",{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":62,"minAge":18,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":65,"phases":363,"briefSummary":364,"conditions":365,"keywords":371,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":199},"100563329","phase-1-a-parg-inhibitor-dat-2645-monotherapy-in-patients-with-advancedmetastatic-solid-tumors-harboring-brca12-loss-of-function-alterations-andor-other-defects-in-the-ddr-pathway-100563329","NCT06614751","A PARG Inhibitor DAT-2645 Monotherapy in Patients with Advanced\u002FMetastatic Solid Tumors Harboring BRCA1\u002F2 Loss of Function Alterations And\u002For Other Defects in the DDR Pathway","A Phase I, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of DAT-2645 in Patients with Advanced\u002FMetastatic Solid Tumors Harboring BRCA1\u002F2 Loss of Function Alterations And\u002For Other Defects in the DNA Damage Repair Pathway","Inclusion Criteria:\n\n* Signed informed consent prior to initiation of any procedures in this study.\n* At least 18 years of age (inclusive).\n* Evidence of an DDR deficiency status in tumor tissue determined by validated testing method.\n* Patients with advanced or metastatic solid tumor who have failed standard of care therapy, or are unable to tolerate standard of care therapy, or unable to obtain\u002Funwilling to receive standard therapy. Regardless of PARP inhibitors were used or not in previous treatment.\n* At least one measurable lesion by RECIST v1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0\\~2.\n* Life expectancy at least 3 months.\n* Adequate hematologic and non-hematologic function during the screening.\n* Women of childbearing potential must have a negative result of serum pregnancy test at screening.\n* Women of childbearing potential or male patients whose spouse have childbearing potential must agree to use a reliable and effective method of contraception during the study and for 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n* Patients who received systemic chemotherapy, small-molecule targeted drugs within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.\n* Patients who received biological anti-tumor drugs (including immunotherapy, target therapy, antibody-drug conjugate \\[ADC\\]) within 4 weeks prior to the first dose of the study drug.\n* Patients who have undergone major surgery within 4 weeks prior to the first dose of study drug.\n* Patients who have received radiotherapy within 4 weeks prior to the first dose of study drug (palliative radiotherapy for non-target lesions could be acceptable if it was performed before 14 days prior to the first dose of study drug).\n* Any previous treatment with a PARG inhibitor.\n* Patients with active CNS metastases (patients with asymptomatic CNS metastases which are imaging stable and not require steroid treatment within 28 days prior to the first dose of study drug, and previous treated breast cancer brain metastasis, can only be enrolled in the Part 2 study).\n* Patients who have second primary malignant tumors within the past 3 years prior to screening, except for those who have been cured of basal cell carcinoma, cervical carcinoma in situ, or breast carcinoma in situ.\n* Patients with clinically significant cardiovascular or cerebrovascular diseases.\n* Active uncontrolled infections requiring intravenous antibiotics or hospitalization.\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of DAT-2645 and no history of bowel obstruction within 6 months prior to enrollment.\n* Known pulmonary interstitial disease or pulmonary interstitial fibrosis.\n* Patients known hypersensitivity to any component or excipient of DAT-2645.\n* Any unresolved toxicities from any prior therapy with severity great than CTCAE Grade 1 prior to start of DAT-2645, except for alopecia and pigmentation and Grade 2 of peripheral sensory neuropathy.\n* Participated in other clinical trials (except for screening failure) within 4 weeks prior to the first dose of the study drug in this study.\n* Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (active HBV infection is defined as positive hepatitis B surface antigen \\[HbsAg\\], or HBV DNA exceeding the lower limit of detection; active HCV infection is defined as positive anti-HCV antibody, and HCV RNA exceeding the lower limit of detection).\n* Known human immunodeficiency virus (HIV) infection (patients with adequate CD4+ T cell counts and without history of acquired immune deficiency syndrome \\[AIDS\\]-defining opportunistic infections could be enrolled after consultation with sponsor).\n* Women who are pregnant or breastfeeding.\n* History or evidence of any other clinically significant condition or disease (with the exception of those outlined above) that, in the opinion of the investigator, would be a risk to patient safety or interfere with the study evaluation, procedures or completion.",{"count":362,"type":21},112,[67],"The primary objective of the study is to evaluate the safety, tolerability, PK, PD, and prilimary efficacy of a PARG inhibitor DAT-2645 in patients with advanced\u002Fmetastatic solid tumors harboring BRCA1\u002F2 loss of function alterations and\u002For other defects in the DNA damage repair (DDR) pathway.",[366,38,367,127,128,133,368,132,134,369,370],"Solid Cancers","HRD Cancer","Pancreatic Cancer","Advanced Cancer","Metastatic Solid Tumors",[372,373,374,375,376,377,378,379,380,381,382,383],"PARGi","DAT-2645","PARPi","Advanced solid tumors","Metastatic solid tumors","HRD gene alteration","Homologous recombination","BRCA","BRCA1\u002F2","PALB2","RAD51C","RAD51D","2024-09-26",{"date":386,"type":47},"2024-09-27",{"date":388,"type":21},"2024-11-01",{"date":390,"type":21},"2027-06-01",{"name":392,"class":146},"Danatlas Pharmaceuticals Co., Ltd",{"id":394,"slug":395,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":397,"acronym":398,"eligibilityCriteria":399,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":400,"enrollmentInfo":401,"targetDuration":403,"studyType":22,"phases":4,"briefSummary":404,"conditions":405,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":4},"100546331","international-registration-of-isolated-stic-to-report-and-investigate-the-risk-of-serous-peritoneal-carcinomatosis-100546331","NCT06393543","International Registration of Isolated STIC: to Report and Investigate the Risk of Serous Peritoneal Carcinomatosis","STICRISC","Inclusion Criteria:\n\n* Women\n* Bilateral salpingectomy (with or without oophorectomy)\n* A serous tubal intraepithelial carcinoma at histopathological review\n\nExclusion Criteria:\n\n* Invasive cancer at initial surgery or pathological examination (either macroscopic and\u002For microscopic)","100 Years",{"count":402,"type":21},600,"10 Years","To prospectively assess the incidence of peritoneal carcinomatosis for women with isolated STIC (serous tubal intraepithelial carcinoma). Moreover, to identify histopathological characteristics of STIC which are reproducible and associated to the risk of peritoneal carcinomatosis and to report the findings of additional diagnostics.",[38,406,407,408],"Serous Tubal Intraepithelial Carcinoma","Ovarian Carcinoma","Peritoneal Carcinoma","2024-04-26",{"date":411,"type":47},"2024-05-01",{"date":413,"type":21},"2024-06",{"date":415,"type":21},"2034-06",{"name":417,"class":54},"Radboud University Medical Center"]