[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Okayama University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":81},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":26,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100641945","financial-toxicity-quality-of-life-and-psychological-resources-in-breast-cancer-survivors--a-longitudinal-study-100641945",false,"NCT07651267","Financial Toxicity, Quality of Life, and Psychological Resources in Breast Cancer Survivors : A Longitudinal Study","Psychological Resources Buffers of the Association Between Financial Toxicity and Quality of Life: A Longitudinal Study of Breast Cancer Survivors","FTQoL-BC","Inclusion Criteria:\n\n* Histopathologically confirmed diagnosis of breast cancer\n* Aware of their diagnosis\n* Able to read and complete the questionnaire\n* Scheduled to undergo a standard chemotherapy regimen\n\nExclusion Criteria:\n\n* History of severe psychiatric disorders (e.g., schizophrenia or bipolar disorder)\n* Another prior cancer diagnosis\n* Evidence of distant metastasis (stage IV disease)\n* Severe comorbid conditions that could interfere with study participation or outcomes (e.g., severe cardiovascular disease or cognitive impairment)","FEMALE","18 Years",{"count":20,"type":21},160,"ESTIMATED","OBSERVATIONAL","Breast cancer survivors face significant financial stress (also called financial toxicity) due to the high costs of cancer treatment. This financial stress can worsen quality of life. Previous studies have demonstrated that breast cancer survivors may draw on inner psychological strengths to cope effectively. This study aims to examine whether psychological resources, specifically resilience and posttraumatic growth (PTG), buffer the longitudinal association between financial toxicity and quality of life (QoL) among breast cancer survivors.\n\nHypotheses: H1: Financial toxicity is negatively associated with QoL over time. H2: Resilience moderates the association between financial toxicity and QoL, such that higher resilience attenuates the negative impact of financial toxicity.\n\nH3: Posttraumatic growth (PTG) moderates the association between financial toxicity and QoL, such that moderate to high levels of PTG attenuate the negative impact of financial toxicity.\n\nParticipants will complete questionnaires at three time points: before their first chemotherapy cycle, at two months (mid-treatment), and at four months (end of chemotherapy). The questionnaires measure financial stress, quality of life, resilience, and posttraumatic growth.\n\nThe study plans to enroll at least 160 participants. Data will be analyzed using statistical methods that track changes across time and test whether resilience and posttraumatic growth buffer the impact of financial stress on quality of life. All data will be de-identified and stored securely.",[25],"Breast Cancer",[27,28,29,30,31,32,33],"Breast cancer survivors","Quality of life","Financial toxicity","Resilience","Posttraumatic growth","Longitudinal study","Women","NOT_YET_RECRUITING","2026-06-21",{"date":37,"type":38},"2026-06-24","ACTUAL",{"date":40,"type":21},"2026-07-15",{"date":42,"type":21},"2027-06-30",{"name":44,"class":45},"Okayama University","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":68,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"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.","ALL",{"count":55,"type":21},23,"INTERVENTIONAL",[58],"PHASE2","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",[61,62,63,25,64,65,66,67],"Triple Negative Breast Neoplasms","Triple Negative Breast Cancer","Breast Neoplasms","BRCA1 Mutation","BRCA2 Mutation","BRCA Mutation","BRCA-Associated Breast Carcinoma",[69,70],"BRCA1 protein","BRCA2 protein","RECRUITING","2025-03-17",{"date":74,"type":38},"2025-03-20",{"date":76,"type":38},"2024-07-16",{"date":78,"type":21},"2028-09-30",{"name":44,"class":45},3,""]