[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-cancer-early-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-cancer-early-breast-cancer":62},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,46,78,100,131,160,192,224,249,283],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100512446","phase-3-an-adjuvant-endocrine-based-therapy-study-of-camizestrant-azd9833-in-erher2--early-breast-cancer-cambria-2-100512446",false,"NCT05952557","An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+\u002FHER2- Early Breast Cancer (CAMBRIA-2)","CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+\u002FHER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease","CAMBRIA-2","Inclusion Criteria:\n\n* Women and Men; ≥18 years at the time of screening (or per national guidelines)\n* Histologically confirmed ER+\u002FHER2- early-stage resected invasive breast cancer with absence of any evidence of metastatic disease as defined in the protocol.\n* Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy.\n* Patients must be randomised within 12 months of definitive breast surgery.\n* Patients may have received up to 12 weeks of endocrine therapy prior to randomisation.\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1\n* Adequate organ and bone marrow function\n\nExclusion Criteria:\n\n* Inoperable locally advanced or metastatic breast cancer\n* Pathological complete response following treatment with neoadjuvant therapy\n* History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered a very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation\n* Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance \"\n* Known LVEF \\\u003C50% with heart failure NYHA Grade ≥2.\n* Mean resting QTcF interval \\> 480 ms at screening\n* Concurrent exogenous reproductive hormone therapy or non topical hormonal therapy for non-cancer-related conditions\n* Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors ( eg, denosumab)\n* Previous treatment with camizestrant, investigational SERDs\u002Finvestigational ER targeting agents, or fulvestrant\n* Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding.\n* Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-\u002Fperi-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists that would preclude the patient from receiving any LHRH agonist.","ALL","18 Years","130 Years",{"count":21,"type":22},5500,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+\u002FHER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.",[28],"Breast Cancer, Early Breast Cancer",[30,31,32],"ER+","HER2-","breast cancer","RECRUITING","2026-06-24",{"date":36,"type":37},"2026-06-25","ACTUAL",{"date":39,"type":37},"2023-10-05",{"date":41,"type":22},"2037-05-06",{"name":43,"class":44},"AstraZeneca","INDUSTRY",798,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100641210","phase-2-skipping-hormone-therapy-in-low-risk-early-breast-cancer-100641210","NCT07661927","Skipping Hormone Therapy in Low-Risk Early Breast Cancer","No Endocrine Therapy in Small HR⁺\u002FHER2- Low Risk Luminal A Early Breast Cancer, a Single-arm De-escalation Trial","NoELA","Inclusion Criteria:\n\n* Postmenopausal (underwent bilateral oophorectomy or non-chemo induced amenorrhea for 12 or more months) female participant ≥60 years of age.\n* New diagnosis of invasive carcinoma of the breast (ductal, tubular or mucinous) with primary tumor ≤1 cm on microscopic exam with no evidence of nodal or distant metastatic disease.\n* Contralateral breast described as BI-RADS (Breast Imaging-Reporting And Data System) 1 or 2 in diagnostic imaging.\n* Negative axillary node involvement by sentinel node biopsy or axillary node dissection (pN0) or Clinically negative axillary node involvement (cN0) after mandatory ultrasound exploration without surgical exploration of the axilla if Breast Conservative Surgery (BCS) was performed.\n* Estrogen Receptor (ER) positive (≥ 50%) and Progesterone Receptor(PR) positive (\\> 20%), Ki67 low (≤15%) and HER2 negative (IHC or In Situ Hybridization approach) according to ASCO (American Society of Clinical Oncology) criteria.\n* Histological grade scored on the invasive component, 1 or 2 if pT1a or grade 1 if pT1b.\n* Treated by mastectomy or BCS with microscopically clear resection margins defined as \"no-ink on tumor\" or ≥1 mm for invasive and non-invasive disease or no residual disease on re-excision.\n* If BCS was performed, participants must have received or have scheduled adjuvant local radiotherapy (RT) within 3 months after surgery\n* No indication of adjuvant chemotherapy.\n* The participant is willing and able to comply with the protocol for the duration of the study, including scheduled visits, treatment strategy, laboratory tests and other study procedures.\n* Participants must be affiliated with a Social Security System (or equivalent).\n* The participant must have signed a written informed consent form before any trial-specific procedures. When the participant is physically unable to give written consent, an impartial witness of her choice, independent from the investigator or the sponsor, can confirm the participant's consent in writing.\n\nExclusion Criteria:\n\n* Have received any neo-adjuvant treatment, including hormone therapy and chemotherapy.\n* Have received or are eligible for adjuvant chemotherapy.\n* Absolute contraindication for RT in case of BCS or patients who were treated with partial breast irradiation.\n* Have been treated with mastectomy and with adjuvant radiotherapy received or scheduled.\n* Invasive lobular breast cancer.\n* Bilateral breast cancer or history of other invasive ipsi- or contralateral breast cancer.\n* Multifocal or multicentric disease.\n* Disease limited to microinvasion only (\\\u003C 1 mm).\n* Evidence of lymphovascular invasion.\n* History of non-breast cancer malignancies if not disease-free for \\> 5 years and considered low risk of recurrence except for treated carcinoma in situ of the cervix, endometrium or colon, melanoma in situ and basal or squamous cell carcinoma of the skin.\n* Non-malignant severe disease associated with a life expectancy \\\u003C 10 years.\n* Women with BRCA1, BRCA2 or other high-risk breast cancer predisposing deleterious germline mutations.\n* Enrolled in another therapeutic study within 30 days prior to inclusion.\n* Unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.\n* Persons deprived of their liberty or under protective custody or guardianship.","FEMALE","60 Years",{"count":57,"type":22},700,[59],"PHASE2","The goal of this clinical trial is to determine whether a selected population of women with early-stage, low-risk breast cancer can avoid hormone therapy without increasing their risk of relapse. It will also evaluate the prognosis of these participants compared to participants who received standard treatment with hormone therapy in another study, estimate the risk of specific recurrence, cardiovascular and bone health, and participants' quality of life.\n\nAll participants will have undergone surgery and possibly radiation therapy, but unlike standard care, they will not receive hormone therapy afterward. Participants will be enrolled for two years and followed for up to five years after the last participant is enrolled in the trial to monitor for long-term cancer recurrence.",[62],"Breast Cancer (Early Breast Cancer)",[32,64,65],"hormone therapy","de-escalation","NOT_YET_RECRUITING","2026-06-16",{"date":69,"type":37},"2026-06-22",{"date":71,"type":22},"2026-06-15",{"date":73,"type":22},"2033-06-15",{"name":75,"class":76},"UNICANCER","OTHER",41,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100498799","phase-3-a-study-of-camizestrant-in-erher2--early-breast-cancer-after-at-least-2-years-of-standard-adjuvant-endocrine-therapy-100498799","NCT05774951","A Study of Camizestrant in ER+\u002FHER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy","CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+\u002FHER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence","CAMBRIA-1","Inclusion Criteria:\n\n* Women and Men, ≥18 years at the time of screening (or per national guidelines)\n* Histologically confirmed ER+\u002FHER2- early-stage resected invasive breast cancer with high or intermediate risk of recurrence, based on clinical-pathological risk features, as defined in the protocol.\n* Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy\n* Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+\u002F- CDK4\u002F6 inhibitor)\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1\n* Adequate organ and marrow function\n\nExclusion criteria:\n\n* Inoperable locally advanced or metastatic breast cancer\n* Pathological complete response following treatment with neoadjuvant therapy\n* History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered at very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation\n* Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance\n* Known LVEF \\\u003C50% with heart failure NYHA Grade ≥2.\n* Mean resting QTcF interval \\>480 ms at screening\n* Concurrent exogenous sex hormone therapy\n* Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors (eg, denosumab)\n* Previous treatment with camizestrant, investigational SERDs\u002Finvestigational ER targeting agents, or fulvestrant\n* Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding\n* Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-\u002Fperi-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists, that would preclude the patient from receiving any LHRH agonist",{"count":87,"type":22},4300,[25],"This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+\u002FHER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.",[28],[30,31,32],{"date":93,"type":37},"2026-06-17",{"date":95,"type":37},"2023-03-31",{"date":97,"type":22},"2036-05-29",{"name":43,"class":44},709,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100638118","cardiac-side-effects-of-systemic-therapy-in-early-stage-breast-cancer-100638118","NCT07588425","Cardiac Side Effects of Systemic Therapy in Early-Stage Breast Cancer","Prospective and Molecular Biomarker-Based Evaluation of Cardiac Side Effects in Patients With Early-Stage Breast Cancer Receiving Systemic Therapy: A Single-Center Observational Cohort Study","C-BREAST-01","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of breast cancer\n* Stage I, II, or III disease\n* Planned neoadjuvant or adjuvant chemotherapy and\u002For HER2-targeted systemic therapy\n* Baseline transthoracic echocardiographic left ventricular ejection fraction (LVEF) ≥ 50%\n* Age ≥ 18 years\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Metastatic (Stage IV) breast cancer\n* Pre-existing heart failure or clinically significant cardiac disease\n* Prior exposure to chemotherapy or other cardiotoxic systemic therapy\n* Concurrent active malignancy other than breast cancer\n* Inability or unwillingness to comply with the planned follow-up and assessment schedule",{"count":109,"type":22},100,"OBSERVATIONAL","The goal of this observational study is to evaluate cardiac side effects in women with early-stage breast cancer who receive systemic chemotherapy and\u002For anti-HER2 therapy as part of their standard cancer care.\n\nThe main questions it aims to answer are:\n\nCan changes in Global Longitudinal Strain (GLS) on echocardiography detect early cardiac dysfunction before a drop in left ventricular ejection fraction (LVEF) becomes apparent? Are changes in circulating microRNA levels in the blood associated with early cardiac dysfunction during cancer treatment? Does cardiac dysfunction occur more frequently with anthracycline-containing chemotherapy compared to anthracycline-free regimens?\n\nParticipants already receiving standard chemotherapy and\u002For anti-HER2 therapy as part of their routine cancer care will undergo echocardiography (LVEF and GLS), provide blood samples for microRNA analysis, and complete quality of life questionnaires at four time points: before treatment (baseline), and at 3, 6, and 12 months after starting treatment.",[62,113,114],"Cardiotoxicity","Cancer Therapy-Related Cardiac Dysfunction",[116,117,118,113,119,120,121],"Early-stage breast cancer","Anthracyclines","Anti-HER2 therapy","GLS","microRNA","Cardio-oncology","2026-05-10",{"date":124,"type":37},"2026-05-14",{"date":122,"type":22},{"date":127,"type":22},"2028-03-30",{"name":129,"class":76},"Fatih GURLER",1,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":54,"minAge":4,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":130},"100627344","luminal-breast-cancer-cryoablation-100627344","NCT07447414","Luminal Breast Cancer Cryoablation","Cryoablation for the Treatment of Luminal Early Breast Cancer","LUBRECA","Inclusion Criteria:\n\n* Postmenopausal women diagnosed with invasive breast cancer by core needle biopsy or vacuum-assisted biopsy\n* Unifocal\n* Lesion ≤ 2 cm (on ultrasound and contrast enhanced mammography)\n* No axillary lymphadenopathy on ultrasound\n* No axillary lymph node involvement on ultrasound.\n* Luminal tumor (estrogen and\u002For progesterone receptor positive)\n* HER2 negative\n* Signed informed consent\n\nExclusion Criteria:\n\n* Infiltrating lobular carcinoma\n* Extensive in situ component\n* Multifocality or multicentricity\n* Contraindication for contrast mammography\n* Not candidate for surgery\n* Distant metastasis -",{"count":140,"type":22},140,[142],"NA","LUBRECA will evaluate the safety and efficacy of cryoablation with liquid nitrogen to treat cT1cN0 luminal breast cancer diagnosed in postmenopausal women",[145,62],"Breast Cancer",[147,148,149,150],"Cryoablation","Liquid nitrogen","Cryosurgery","Percutaneous treatment","2026-04-15",{"date":153,"type":37},"2026-04-16",{"date":155,"type":37},"2026-04-08",{"date":157,"type":22},"2028-12",{"name":159,"class":76},"Lucía Graña López",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":168,"targetDuration":170,"studyType":110,"phases":4,"briefSummary":171,"conditions":172,"keywords":177,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":130},"100622153","real-life-evaluation-of-endopredict-in-early-hrher2--breast-cancer-100622153","NCT07379918","Real-life Evaluation of Endopredict® in Early HR+\u002FHER2- Breast Cancer","French Prospective Real-life Evaluation of the Endopredict® Genomic Signature for HR-positive,HER2-negative Early Breast Cancer","SiMoSein","Inclusion Criteria:\n\n* Patient with early breast cancer, hormone receptor-positive, HER2 non-amplified, for whom clinical criteria are deemed insufficient to determine the need for adjuvant chemotherapy, combined with hormone therapy, after breast surgery.\n\nExclusion Criteria:\n\n* Patients who did not undergo testing or whose test results were not validated",{"count":169,"type":22},1000,"10 Years","EndoPredict is a genomic signature used to determine the 10-year risk of recurrence in early HR+\u002FHER2- breast cancers classified as of intermediate risk according to conventional clinical and pathological criteria, and to guide the adjuvant treatment decision: hormone therapy alone or hormone therapy and chemotherapy.\n\nSince 2016, french laboratories performing the Endopredict test, included prospectively analyzed tumors in the SiMoSein registry with data collection : age, tumor size, lymph node status, histology, grade, HR and HER2 IHC status, Ki67, EPscore, Epclin score, risk of relapse, absolue benefit from chemotherapy, risk of late relapse\n\nThe main objectives of the trial are to:\n\nEvaluate long-term relapse-free survival and overall survival over a 10-year period in breast cancer patients who underwent EndoPredict® testing according to:\n\n* EPclin risk class (low vs. high),\n* Lymph node status (N0\u002FN1),\n* Tumor size (pT),\n* Age groups (\\\u003C40 years, 40-49 years, 50-69 years, ≥70 years),\n* EP score alone.\n\nThis study provide real-life data to determine the clinical usefulness of this molecular signature in the management of early HR+\u002FHER2- breast cancers. The ultimate goal is to be able to offer therapeutic de-escalation (avoiding chemotherapy) to patients who are reliably assessed as having a low risk of relapse.",[62,173,174,175,176],"Breast Cancer Survivors","Breast Cancer Prognostic","Early Hormone Receptor-positive (HR-positive)","HER2-negative Breast Cancer",[32,178,179,180,181,182],"early breast cancer","EndoPredict test","survival","HR positive","HER2 negative","2026-03-12",{"date":185,"type":37},"2026-03-13",{"date":187,"type":22},"2026-06-28",{"date":189,"type":22},"2031-06-28",{"name":191,"class":76},"Assistance Publique - Hôpitaux de Paris",{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":199,"enrollmentInfo":200,"targetDuration":4,"studyType":23,"phases":202,"briefSummary":203,"conditions":204,"keywords":208,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":130},"100625649","prehabilitation-in-breast-cancer-surgery-100625649","NCT07425379","Prehabilitation in Breast Cancer Surgery","Prehabilitation in Breast Cancer Surgery: A Prospective Randomized Controlled Trial Evaluating Shoulder Function, Pain, Quality of Life and Lymphedema Development","Inclusion Criteria:\n\nWomen aged 18-80\n\nStage I-III invasive breast cancer\n\nScheduled for surgery\n\n≥3 weeks before surgery\n\nNo neoadjuvant therapy\n\nExclusion Criteria:\n\nExercise contraindication\n\nActive shoulder pathology\n\nSevere cardiopulmonary disease\n\nPlanned neoadjuvant therapy","80 Years",{"count":201,"type":22},54,[142],"This prospective, randomized, assessor-blinded, parallel-group clinical trial evaluates the effectiveness of a home-based upper extremity-focused prehabilitation program in women undergoing breast cancer surgery. Participants will be randomized 1:1 to either prehabilitation or usual care. Primary outcomes include shoulder range of motion and upper extremity function (DASH score). Secondary outcomes include grip strength, pain, fatigue, disability, anxiety\u002Fdepression, and lymphedema incidence up to 2 years postoperatively.",[62,205,206,207],"Postoperative Shoulder Dysfunction","Lymphedema Arm","Cancer Rehabilitation",[209,210,211,212,207,213],"Prehabilitation","Breast Cancer Surgery","Shoulder Range of Motion","Upper Extremity Function","Exercise Therapy","2026-02-23",{"date":216,"type":37},"2026-02-24",{"date":218,"type":22},"2026-03-01",{"date":220,"type":22},"2028-12-01",{"name":222,"class":223},"Bakirkoy Dr. Sadi Konuk Research and Training Hospital","OTHER_GOV",{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":232,"enrollmentInfo":233,"targetDuration":235,"studyType":110,"phases":4,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":248},"100235078","praegnant-breast-cancer-earlyadvancedmetastatic-100235078","NCT02338167","Praegnant Breast Cancer: Early\u002FAdvanced\u002FMetastatic","Prospective Academic Translational Research Network for the Optimization of the Oncological Health Care Quality in the Adjuvant and Advanced\u002FMetastatic Setting: Health Care Research, Pharmacogenomics, Biomarkers, Health Economics","PRAEGNANT","Inclusion Criteria for the early breast cancer setting:\n\n* Adult breast cancer patients (age ≥18 years)\n* Patients with breast cancer and no evidence of distant metastases with a diagnosis not longer than 91 days before study entry\n* Patients, who are able and willing to sign the informed consent form\n\nInclusion Criteria for the advanced\u002Fmetastatic setting:\n\n* Adult women aged ≥18 years\n* Patients with the diagnosis of invasive breast cancer (in German: Mammakarzinom, as op-posed to \"non-invasive\"= ductales Carcinoma in situ; irrespective of status of BC, e.g. TNM, re-ceptor status etc.) and\n* Patients, who are willing and able to sign the informed consent form\n* Patients with metastatic or locally advanced, inoperable disease proven by clinical measures (i.e. standard imaging)\n\nExclusion Criteria:\n\n* Patients who did not sign the informed consent form\n* Patients, who are not eligible for observation due to non-availability and\u002For severe comor-bidities as evaluated by the treating physician","99 Years",{"count":234,"type":22},13500,"60 Months","Among patients with breast cancer the subgroup of patients with metastases are considered the group of patients with the worst prognosis. Not only regard-ing therapy decisions but also with regard to quality assured healthcare and health economics this entity of patients remains a challenge.\n\nRecently, novel advances in breast cancer therapy aim at the targeted therapy of tumor entities and identification of patients, for whom the greatest therapy benefit, and the least side effects are expected.\n\nHowever molecular assessment of the patient and the tumor in the metastatic situation is not performed on a routine basis and in many cases tumor character-istics from the primary tumor are considered reliable enough to make therapy decisions for the metastatic patients. Although molecular reassessment of tu-mor characteristics from tumor material of the metastasis is recommended in national guidelines, only a minority of patients is biopsied, because of the inva-siveness of the procedure, even though biopsy related complications are reported to be rare.\n\nWith modern analytic methods from blood based biomaterial there seems to be an opportunity to correlate blood based tumor assessments with actual charac-teristics of the tumor. These include expression analysis, tumor mutation analy-sis, tumor gene copy number aberrations and others. One of the main aims of the PRAEGNANT study is therefore to establish an infrastructure for the compre-hensive analysis of tumor and metastatic molecular characteristics of the patient and the tumor.\n\nFurthermore, health care related outcomes as well as health economics provide novel approaches for integration of patients in study conduct and health care awareness and are study aims of the PRAEGNANT study.",[238,62],"Advanced\u002FMetastatic Breast Cancer","2026-01-28",{"date":241,"type":37},"2026-01-30",{"date":243,"type":37},"2014-06",{"date":245,"type":22},"2030-07",{"name":247,"class":76},"University Hospital Tuebingen",61,{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":255,"sex":54,"minAge":256,"maxAge":257,"enrollmentInfo":258,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":260,"conditions":261,"keywords":269,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":130},"100618429","validation-of-the-oncoliq-test-for-the-early-detection-of-breast-cancer-100618429","NCT07331506","Validation of the Oncoliq Test for the Early Detection of Breast Cancer.","Inclusion Criteria:\n\nGroup 1 - Breast Cancer:\n\nAge between 40 and 70 years Diagnosis of breast cancer at any stage No prior surgical treatment No prior antineoplastic treatment Pathology report available at the time of enrollment Signed informed consent\n\nGroup 2 - No Cancer (Control):\n\nAge between 50 and 70 years No diagnosis or personal history of any type of cancer Digital mammography and breast ultrasound showing no breast pathology (BI-RADS 1 or 2) Signed informed consent\n\nExclusion Criteria:\n\nRefusal to sign the informed consent Communication issues that hinder understanding (hearing loss, blindness, intellectual disability, or dementia) Venipuncture for blood collection impracticable or posing a risk Personal history of previous cancer",true,"40 Years","70 Years",{"count":259,"type":22},300,"Cancer continues to be one of the most significant public health issues worldwide. Thanks to early detection, the mortality rate of certain types of cancer has decreased significantly. However, the lack of accessible, low-cost, non-invasive, non-toxic, and easy-to-implement diagnostic methods results in late diagnoses, leading to 1 in every 6 people dying from cancer today.\n\nMicroRNAs (miRNAs) are small non-coding RNAs that regulate gene expression and are found both inside cells and in bodily fluids such as blood and urine. Several studies have demonstrated their role in human diseases, especially cancer, where tumors release miRNAs into the bloodstream that can be used as biomarkers for early detection.\n\nThe research and development team at Oncoliq SAS identified a panel of miRNAs associated with breast cancer, with a detection performance of 82% sensitivity and 83% specificity, validated in exploratory and preliminary confirmatory studies. These results led to the filing of a patent based on liquid biopsy technology.\n\nThe objective of this protocol is to establish a panel of miRNAs for the early detection of breast cancer using samples from breast cancer patients and a cancer-free control group. Validation of the miRNAs will be carried out through RT-qPCR. This stage constitutes the analytical validation of the biomarkers, with the goal of developing an algorithm capable of classifying individuals with and without breast cancer. In future stages, a pilot clinical trial is planned to evaluate test implementation and clinical validation.",[262,263,264,265,266,267,62,268],"Breast Cancer Detection","Breast Cancer Early Stage Breast Cancer (Stage 1-3)","Breast Cancer Female","Breast Cancer - Ductal Carcinoma in Situ (DCIS)","Breast Cancer - Infiltrating Ductal Carcinoma","Breast Cancer With Low to Intermediate HER2 Expression","Breast Cancer - Female",[270,271,272,273],"Breast cancer","Detection","Liquid biopsy","miRNAs","2026-01-13",{"date":276,"type":37},"2026-01-15",{"date":278,"type":37},"2025-10-17",{"date":280,"type":22},"2026-02-28",{"name":282,"class":44},"Oncoliq US Inc",{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":257,"enrollmentInfo":290,"targetDuration":4,"studyType":23,"phases":292,"briefSummary":293,"conditions":294,"keywords":295,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":130},"100598431","a-study-on-the-treatment-of-early-small-breast-cancer-with-ultrasound-guided-vacuum-assisted-excision-combined-with-surgery-100598431","NCT07071402","A Study on the Treatment of Early Small Breast Cancer With Ultrasound-guided Vacuum-assisted Excision Combined With Surgery","A Single-center, Single-arm, Open Study on the Treatment of Early Small Breast Cancer With Ultrasound-guided Vacuum-assisted Excision Combined With Surgery","Inclusion criteria：\n\nSubjects must meet all of the following inclusion criteria to be enrolled in this trial:\n\n* Age: 18 - 70 years old;\n* Female patients;\n* Patients diagnosed with suspected breast cancer through imaging (such as breast ultrasound, mammography, etc.) with BI - RADS Category 4C and Category 5;\n* Clinical stage T1: Mass ≤2cm;\n* No previous treatment related to breast cancer;\n* Be willing to undergo ultrasound - guided vacuum - assisted resection, biopsy and surgical treatment; 7) The subjects voluntarily join this study and sign the informed consent form.\n\nExclusion criteria：\n\nThose with any of the following circumstances will not be selected as subjects:\n\n* Imaging suggests that the lesion is greater than 2cm;\n* Suspected positive axillary lymph nodes in imaging (Bedi 4, Bedi 5, Bedi 6);\n* The tumor invades the nipples, areolas and subcutaneous tissues;\n* Breast cancer during pregnancy;\n* Abnormal functions of vital organs such as the heart, lungs, liver and kidneys, and poorly controlled diabetes, etc., cannot tolerate surgery;\n* Any other circumstances in which the researcher deems the patient unsuitable to participate in this study.",{"count":291,"type":22},120,[142],"The aim of this clinical trial is to assess the feasibility and safety of ultrasound-guided vacuum-assisted excision (VAE) in the treatment of early breast cancer with Tis (carcinoma in situ) or T1 (maximum tumor diameter ≤2cm) and negative axillary lymph nodes on imaging. The main question it aims to answer is:\n\n* After VAE, when undergoing routine breast cancer surgery again, what is the complete resection rate of the lesion in the surgically removed tissue (pathologically confirmed), that is, the false negative rate of VAE?\n* Which type of breast cancer lesion has the highest complete resection rate?\n* Is it clear whether VAE can be applied in the treatment of early breast cancer with Tis or T1 and negative axillary lymph nodes on imaging?\n* Do patients with benign breast nodules who undergo VAE or are recommended for Vacuum-assisted breast biopsy (VABB) due to limited puncture and are diagnosed with breast cancer need to undergo surgery again?\n* The incidence of complications of VAE.\n\nParticipants will:\n\n* Single early breast cancer subjects with Tis or T1 and negative axillary lymph nodes on imaging, after being fully informed and signing the informed consent form, enter the trial period after screening and being qualified.\n* After the subjects are confirmed to be enrolled, VAE biopsy resection is performed first.\n* Patients clearly diagnosed with breast cancer receive traditional radical mastectomy for breast cancer: Breast-conserving surgery or total mastectomy, sentinel lymph node biopsy or dissection in the axilla, assessment of whether the lesion has been completely removed based on postoperative pathology, and follow-up is conducted.",[62],[296],"vacuum-assisted excision","2025-08-14",{"date":299,"type":37},"2025-08-15",{"date":301,"type":37},"2025-07-18",{"date":303,"type":22},"2029-06-01",{"name":305,"class":76},"Xijing Hospital"]