[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"triple-negative-breast-cancer-tnbc-early-setting\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:triple-negative-breast-cancer-tnbc-early-setting":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,39,73],{"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":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100635367","diet-drive-gut-microbiome-and-outcome-in-patients-with-early-stage-triple-negative-breast-cancer-undergoing-neoadjuvant-chemotherapy-and-immunotherapy-100635367",false,"NCT07551765","Diet-drive Gut Microbiome and Outcome in Patients With Early-stage Triple-negative Breast Cancer Undergoing Neoadjuvant Chemotherapy and Immunotherapy.","Diet-driven Gut Microbiome and Outcome in Patients With Early-stage Triple-negative Breast Cancer Undergoing Neoadjuvant Chemotherapy and Immunotherapy.","CAPTIVATE","Inclusion Criteria:\n\n* Willing and able to provide written informed consent prior to study entry\n* Female ≥ 18 years of age\n* Histologically confirmed operable primary breast cancer with a tumor size of ≥1 cm\n* Triple-negative disease:\n* defined as tumours with \\\u003C10% of tumours cells positive for ER and PR1 on IHC staining or an IHC score (Allred) \\\u003C 3\n* HER2-negative tumours defined as 0, 1+ or 2+ intensity on IHC and no evidence of amplification of the HER2 gene on ISH. defined as tumours with\n* Patient planned to undergo neoadjuvant chemotherapy (as per institutional standard) with\u002Fwithout immunotherapy\n* Representative formalin-fixed paraffin embedded (FFPE) breast tumours samples with an associated pathology report that are determined to be available and sufficient for central testing OR tumours accessible for biopsy.\n* Ability to comply with the protocol, including but not limited to, completion of the patient-reported outcomes questionnaires Exclusion Criteria: Patients meeting any of the following exclusion criteria are not be enrolled in the study.\n* Previous systemic or local treatment for the new primary breast cancer currently under investigation (including surgery, radiotherapy, cytotoxic and endocrine treatments)\n* Received therapeutic oral or intravenous antibiotics within 14 days prior to randomization\n* Known distant metastases","FEMALE","18 Years",{"count":20,"type":21},300,"ESTIMATED","OBSERVATIONAL","CAPTIVATE is a multi-center translational and observational trial, that aims to investigate the impact of the gut microbiome on treatment outcomes in women with untreated, stage I-III Triple Negative undergoing neoadjuvant treatment with and without immune checkpoint inhibitors. As part of the trial, stool samples, core tumors biopsies and research bloods samples for the analysis will be collected at various points of the study.",[25],"Triple Negative Breast Cancer (TNBC), Early Setting","NOT_YET_RECRUITING","2026-04-20",{"date":29,"type":30},"2026-04-27","ACTUAL",{"date":32,"type":21},"2026-11-13",{"date":34,"type":21},"2032-11-01",{"name":36,"class":37},"Barts & The London NHS Trust","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":47,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100580027","phase-2-lifestyle-intervention-to-enhance-efficacy-of-neoadjuvant-therapy-in-patients-with-triple-negative-breast-cancer-100580027","NCT06831955","LifEStyle Intervention to Enhance Efficacy of Neoadjuvant Therapy in Patients With Triple Negative Breast Cancer","The LESLIE Trial: LifEStyle Intervention to Enhance Efficacy of Neoadjuvant Systemic Therapy in Patients With Triple Negative Breast Cancer","LESLIE","Inclusion Criteria:\n\n* The patient has a biopsy-confirmed diagnosis of stage II-III TNBC\n\n  1. Patients with tumor stage T1cN1-2, T2N0-N2, T3N0-N2, T4N0-N2\n  2. ER and PR negative is defined as an absent or minimal (≤10%) expression of oestrogen and progesterone receptors and absence of HER2 protein over-expression per ASCO\u002FCAP-guidelines\n  3. All histological subtypes are eligible, including but not limited to invasive breast cancer of no special type (NST) , invasive lobular carcinoma (ILC) etc\n* WHO\u002FECOG performance status of grade 0-1\n* The participant is able to perform a CPET test (cardiopulmonary exercise testing)\n* Body mass index ≥ 18.5 kg\u002Fm²\n* Pregnant or breastfeeding women\n* Presence of adequate bone marrow and organ function\n* HbA1c \\\u003C10%\n\nExclusion Criteria:\n\n* had a treatment with any of the following:\n\n  1. any other chemotherapy, immunotherapy or anticancer agents within 5 years of the first dose of study treatment\n  2. injectable hypoglycemics 2. have not have recovered adequately from the toxicity and\u002For complications from a surgical intervention prior to starting therapy\n* prior systemic treatment for breast cancer or other malignancies within 5 years of treatment enrollment, except for adequately treated basal cell or squamous skin cancer or in situ cervical cancer. Other malignancies diagnosed more than 5 years before the diagnosis of breast cancer must have been radically treated without evidence of relapse at the moment of patient enrollment in the trial.\n* has a history of an additional malignancy that is progressing or that has required active treatment in the 5 years prior to breast cancer diagnosis. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer\n* Prior treatment with anthracyclines\n* Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137)\n* Has any disorder, which in the Investigator's opinion might jeopardize the participant's safety or compliance with the protocol\n* Has, as judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV). Screening for chronic conditions is not required\n* Active autoimmune diseases requiring systemic treatments\n* Patients with type 1 diabetes mellitus\n* History of alcohol use disorder (DSM-5)\n* History of eating disorder (DSM-5)","ALL",{"count":49,"type":21},356,"INTERVENTIONAL",[52],"PHASE2","LESLIE is a multicentric randomized controlled trial in patients with triple negative breast cancer receiving neoadjuvant chemo\u002Fimmunotherapy (NAT). This trial investigates the hypothesis that adding a cyclic fasting-mimicking diet combined with exercise during the NAT improves the NAT's therapeutic efficacy, treatment tolerability and compliance, as well as improve quality of life.",[25],[56,57,58,59,60,61],"Triple Negative Breast Cancer","Lifestyle Intervention","Neoadjuvant treatment","Fasting-Mimicking Diet","Exercise therapy","Pathological Complete Response","RECRUITING","2026-03-18",{"date":65,"type":30},"2026-03-20",{"date":67,"type":30},"2026-02-01",{"date":69,"type":21},"2031-09-01",{"name":71,"class":37},"Universitaire Ziekenhuizen KU Leuven",10,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":47,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":50,"phases":83,"briefSummary":85,"conditions":86,"keywords":91,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":4},"100630362","phase-3-pembrolizumab-adjuvant-in-patients-with-early-stage-triple-negative-breast-cancer-with-residual-disease-after-neoadjuvant-pembrolizumab-plus-chemotherapy-100630362","NCT07486687","Pembrolizumab Adjuvant in Patients With Early-stage Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy","PembroLizumab Adjuvant in Patients With Early-stage Triple NEgaTive Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy - the Multicenter, Randomized Phase III, Pragmatic PLANET Trial","PLANET","Inclusion Criteria:\n\n1. Male or female, ≥18 years of age on day of signing informed consent\n2. Stage II or III TNBC prior to the start of neoadjuvant treatment\n\n   1. Locally assessed stage II or III TNBC according to the primary tumor (T) and regional lymph node (N) staging as per the American Joint Committee on Cancer (AJCC) for breast cancer staging criteria version 8\n   2. Locally assessed estrogen receptor (ER) and\u002For progesterone receptor (PR) expression \\\u003C10% and HER2-negative according to the ASCO-CAP guideline1\n3. The patient has received neoadjuvant treatment with chemotherapy (containing at least anthracyclines and taxanes) and pembrolizumab, with a minimum of two 6-weekly (or four 3-weekly) cycles of pembrolizumab\n4. The patient underwent breast surgery ≤12 weeks prior to inclusion in the study\n5. The patient is scheduled to start standard of care adjuvant treatment with capecitabine or olaparib (pending reimbursement), based on non-pCR after neoadjuvant treatment, defined as RCB score \\>02\n6. World Health Organization (WHO) performance status 0-2\n7. Adequate organ function, as assessed ≤30 days prior to the screening:\n\n   1. Absolute neutrophil count (ANC) ≥1,000\u002Fmm3 (1.0 x 10e9 \u002FL)\n   2. Platelets ≥50,000\u002Fmm3 (50 x 10e9 \u002FL);\n   3. Estimated creatinine clearance ≥ 30 mL\u002Fmin as calculated using the method standard for the institution;\n   4. Total serum bilirubin ≤1.5 x upper limit of normal (ULN) (≤3.0 x ULN if Gilbert's disease);\n   5. Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤3 x ULN\n8. Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 6 months after the last dose of study medication\n9. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures\n10. Willingness to provide written informed consent, according to the Good Clinical Practice (GCP) and national\u002Flocal regulations\n\nExclusion Criteria:\n\n1. Contra-indications for any of the study drugs\n2. Other invasive malignancies, except when treated with curative intent without chemotherapy AND more than 5 years ago\n3. The presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n4. Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study",{"count":82,"type":21},1000,[84],"PHASE3","The phase III, multicenter, pragmatic PLANET trial aims to evaluate the benefit and safety of pembrolizumab as an addition to standard of care adjuvant treatment (capecitabine or olaparib) in triple negative breast cancer (TNBC) patients with residual disease (non-pCR) after neoadjuvant chemotherapy and pembrolizumab. All study procedures resemble routine clinical practice as much as possible (i.e., pragmatic clinical trial). In addition to the randomized trial, a registry will be set up, in which patients who reach pCR (and therefore, do not receive adjuvant treatment) will be registered and followed.",[25,87,88,89,90],"Early Stage Triple-Negative Breast Carcinoma","Triple -Negative Breast Cancer","Breast Cancer Stage II","Breast Cancer Stage III",[92,93,94,95,96,97],"Immunotherapy","Pembrolizumab","Triple negative breast cancer","Breast cancer","TNBC","Adjuvant","2026-03-17",{"date":65,"type":30},{"date":101,"type":21},"2026-04",{"date":103,"type":21},"2036-04",{"name":105,"class":37},"The Netherlands Cancer Institute"]