[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Institute of Oncology, Hungary\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":129},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,73,96,114],{"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":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100598126","single-fraction-very-accelerated-partial-breast-irradiation-sfvapbi-100598126",false,"NCT07067437","Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI)","Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI) in Low-Risk Invasive or Ductal In Situ Breast Carcinoma - Phase II Multicenter Trial","sfVAPBI","Inclusion Criteria:\n\n* Stage 0 \\& I \\& II (\\\u003C 3 cm) breast carcinoma\n* Lesions of \\\u003C 3 cm diameter\n* Invasive carcinoma of any subtype and grade or ductal carcinoma in situ (DCIS)\n* Nodal status: node-negative (pN0) or micro-metastatic (pN1mi) (patients with pN1mi status can be treated, but due to the limited clinical evidence, individual decision is needed)\n* M0: Absence of distant metastasis\n* Clear resection margins by National Surgical Adjuvant Breast and Bowel Project (NSABP) definition (no tumor on ink)\n* Unifocal (multifocality limited within 2 cm) and unicentric breast cancer\n* Age\\> 40 years\n* Luminal A or B tumors\n* Time interval from surgery preferably less than 12 weeks and no longer than 20 weeks, and from adjuvant chemotherapy less than 4 weeks\n* Human Epidermal growth factor Receptor 2 positive (HER2+) patients receiving postoperative anti-HER2 systemic therapy\n* Specific signed consent form prior to randomization\n\nExclusion Criteria:\n\n* Stage III-IV breast cancer\n* Surgical margins that cannot be microscopically assessed\n* Extensive intraductal component (EIC+)\n* Extensive lymphovascular invasion (LVI+) (focal is allowed)\n* Triple negative breast cancer\n* BReast CAncer gene (BRCA) 1-2 mutation\n* Human Epidermal growth factor Receptor 2 positive (HER2+) patients not receiving postoperative anti-HER2 systemic therapy\n* Neoadjuvant systemic therapy\n* Paget's disease or pathological skin involvement\n* Synchronous or previous breast cancer.\n* Pregnant or lactating women","FEMALE","40 Years",{"count":20,"type":21},250,"ESTIMATED","INTERVENTIONAL",[24],"NA","To investigate clinical outcomes, late side effects, and cosmetic results of a single-fraction very accelerated partial breast irradiation as postoperative local treatment for the treatment of early stage breast cancer.",[27],"Breast Neoplasms",[29,30],"breast cancer","brachytherapy","RECRUITING","2025-07-05",{"date":34,"type":35},"2025-07-16","ACTUAL",{"date":37,"type":35},"2025-07-01",{"date":39,"type":21},"2032-08-01",{"name":41,"class":42},"National Institute of Oncology, Hungary","OTHER",22,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":56,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100449393","neoadjuvant-treatment-of-breast-cancer-100449393","NCT05131893","Neoadjuvant Treatment of Breast Cancer","Neoadjuvant Treatment of Breast Cancer - a Prospective Observational Study, PANnon ONCology (PANONC) Group Non-commercial Clinical Trial","Inclusion Criteria:\n\n1. Participant over 18 years of age .\n2. Histologically confirmed (core biopsy) invasive breast tumor.\n3. Tumor extent for the indication:\n\n   * regression must be achieved for radical surgical removal or\n   * regression is required for breast-conserving surgery or\n   * if hormone receptor (HR)-positive and Her2-: stage IIB (cT2N1 or cT3NO) - IIIC,\n   * if HR-negative: stage IIA (cT2N0 or cT0-1N1) - IIIC Note: In the case of a locally advanced, irresectable case, if the possibility of radical surgery later is a realistic goal, the participant may be included in the study.\n4. Appropriate general condition: ECOG 0-1\n5. Proper organ function\n\n   * Neutrophil count ≥ 1.5 G \u002F l, platelet count ≥ 100 G \u002F l, hemoglobin ≥ 10 g \u002F dl\n   * Alanine aminotransferase (ALT) \u002F aspartate aminotransferase (AST) is less than 1.5 times the upper limit of the normal range\n   * bilirubin less than 1.5 times the upper limit of the normal range (except Gilbert's disease, where less than 3 times)\n   * creatinine less than 1.5 times the upper limit of the normal range or estimated glomerular filtration rate (eGFR) higher than 60 ml \u002F min\n\nExclusion Criteria:\n\n1. Proven or suspected distant metastasis.\n2. No staging studies have been performed: at least chest x-ray, abdominal ultrasound. It is preferred to perform CT from the chest, abdomen, pelvic regions and bone isotope, or PET \u002F CT if possible in case of lymph node involvement.\n3. Known significant heart disease: major arrhythmia or significant conduction defect (grade 2 or more), infarction or unstable angina within 6 months, cardiac collapse without appropriate therapy, long QT syndrome, heart failure (≥New York Heart Association\u002FNYHA II)\n4. Other severe acute or chronic conditions (organic or psychiatric illness, laboratory abnormality) that, in the opinion of the treating physician, result in an unacceptable increase in the risk of chemotherapy and are contraindicated in routine clinical practice.\n5. Pregnancy or if the participant does not agree to use an appropriate non-hormonal method of contraception.","ALL","18 Years","100 Years",{"count":55,"type":21},300,"10 Years","OBSERVATIONAL","Observational investigation of participants who are given neoadjuvant treatment for invasive breast cancer. The scope of the study is to collect information on standardized treatment results, to explore the causes of dose modification and its effect on efficacy, to explore potential prognostic factors, and to explore the long-term side effects of different treatment modalities.",[60],"Breast Cancer",[62],"Neoadjuvant systemic therapy","NOT_YET_RECRUITING","2021-11-20",{"date":66,"type":35},"2021-11-23",{"date":68,"type":21},"2022-03",{"date":70,"type":21},"2031-12",{"name":41,"class":42},1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":17,"minAge":52,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":72},"100389849","examining-and-comparing-the-temporal-changes-and-results-of-cosmetic-quality-of-life-and-patient-satisfaction-achieved-with-immediate-and-delayed-immediate-implant-based-breast-reconstruction-procedures-and-contralateral-symmetrization-techniques-100389849","NCT04356235","Examining and Comparing the Temporal Changes and Results of Cosmetic, Quality of Life and Patient Satisfaction Achieved With Immediate and Delayed-immediate Implant-based Breast Reconstruction Procedures and Contralateral Symmetrization Techniques","Examining and Comparing Patient Satisfaction and Long-term Cosmetic Results Achieved With Implant-based Breast Reconstruction Surgery With Submuscular Silicone Implant After Skin Sparing \u002F Areola Sparing \u002F Nipple Sparing Mastectomy and Contralateral Symmetrization (With Mastopexy and\u002For Silicone Implant and\u002For Ultrapro Mesh) With Unilateral Simple Mastectomies and With Bilateral Skin-sparing Mastectomies and Implant-based Immediate Breast Reconstructions. Response-adaptive Prospective Randomized, Comparative Clinical Trial","Inclusion Criteria:\n\n* Under the age of 65 with uni- or bilateral primary breast cancer ( clinical Stage 0-III), needing modern skin sparing mastectomy, nipple sparing mastectomy or areola sparing mastectomy independently of the axillary surgery, having immediate or delayed-immediate implant based reconstrucion on the ipsilateral side and symmetrisation on the contralateral side ( mastopexy and\u002For implant based reconstruction and\u002For breast sling with ultrapro mesh)\n* Control group: patients under 65 years with unilateral simplex mastectomy without breast reconstruction\n\nExclusion Criteria:\n\n* In case the patient does not volunteer for the examination or the follow-ups\n* Age above 65 years or poor general health condition, where the estimated life expectancies would be less than 2 years even without the tumorous disease\n* Malignant invasive tumor in the past history (except for non-melanoma skin tumors)\n* Mastectomyand reconstruction performed due pregnancy associated breast cancer\n* Prior breast surgery (e.g. aesthetic surgery, mastopexy) and\u002For radiotherapy on the breast or in the axilla\n* Malignant tumor is not removed completely with pathological examination\n* Severe non-surgical (e.g. radiotherapy) complication, which could influence the aesthetic and functional results\n* Autoimmune diseases\n* Mastitis carcinomatosa\n* Lymphangitis carcinomatosa\n* Open wound therapy due SSI\n* Long-term steroid usage, which changed the skin's quality and structure\n* Patient under foster care, or psychically non-cooperative patient\n* If breast correction performed during the 5 years follow up",true,"65 Years",{"count":83,"type":21},528,"This is a response-adaptive (RAR) prospective randomized study with a long-term follow-up and the aim of this clinical study is to measure with qualitative and quantitative indicators the changes in cosmetic results, quality of life and patient satisfaction after breast reconstructive surgery with silicone implant (following SSM, ASM or NSM mastectomy) and symmetrization (mastopexy and\u002For silicone implant and\u002For Ultrapro mesh sling technique) over time.\n\nAccording to the hypothesis of the study, the results of implant-based breast reconstruction and symmetrization following advanced postmastectomy techniques significantly decrease over time and later results limited patient satisfaction rate.\n\nThis is mainly due to the fact that over time, the natural breast differs from the reconstructed breast with silicone implant. Because of the different biological properties (gravity results ptosis on breast with mastopexy, significant volume increasement of the breast with mastopexy due to endocrine therapy, gradually progressive capsular contracture on the tumorous side, nipple flattening, nipple tattoo fading etc.) the two sides change differently resulting in significant asymmetry and consequently could lead to decreased patient satisfaction.\n\nThe high degree of asymmetry over time (which can be similar to the difference between the result of a simple mastectomy and natural breast (control group)), may indicates additional surgeries or usage of medical devices, putting a financial burden on the patient and the health system. On the other hand, the symmetry can be achieved with bilateral skin-sparing mastectomies and implant-based immediate or delayed-immediate reconstructions is clearly better and change less with time. The mastectomy of the contralateral disease-free side is considered as an unreasonable burden for moderate risk patients.\n\nThe information such as the need for multiple surgeries, change in symmetry over time etc., should be an important part of the professional decision-making mechanism and the surgeon should inform the patient during the primer surgery. Nowadays due to the lack of evidence-based knowledge, it is not part of the patient's information and surgical planning internationally. Planning breast units, attention, capacity and financial resources must also be provided to meet the long-term needs of patients who underwent postmastectomy breast reconstruction. Simple mastectomy with an external prosthesis can be an alternative for patients with intolerable degree of asymmetry or on the contrary, the results may justify the need for bilateral mastectomy and reconstruction even in the absence of high oncological risk and for purely symmetrical and cosmetic reasons.",[86,60,87],"Mastectomy; Lymphedema","Quality of Life","2020-04-21",{"date":90,"type":35},"2020-04-22",{"date":92,"type":21},"2020-04-27",{"date":94,"type":21},"2027-04-10",{"name":41,"class":42},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":81,"enrollmentInfo":103,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":110,"completionDateStruct":111,"leadSponsor":113,"locationsCount":72},"100388993","examining-the-cosmetic-results-quality-of-life-and-patient-satisfaction-achieved-with-skin-reducing-nipple-sparing-mastectomy-and-implant-based-breast-reconstruction-and-comparing-it-to-classic-skin--sparing-mastectomy-and-implant--based-breast-reconstructive-surgeries-100388993","NCT04345081","Examining the Cosmetic Results, Quality of Life and Patient Satisfaction Achieved With Skin Reducing Nipple Sparing Mastectomy and Implant Based Breast Reconstruction, and Comparing it to Classic Skin- Sparing Mastectomy and Implant- Based Breast Reconstructive Surgeries","Examining the Cosmetic Results and Patient Satisfaction Achieved With Skin Reducing Nipple Sparing Mastectomy of Ptotic Breast Followed by Delayed-immediate Submuscular Implant Based- Breast Reconstruction Surgery, and Comparing it to Submuscular Delayed- Immediate Implant- Based Breast Reconstruction Procedures After Skin- Sparing Mastectomy. Response-adaptive, Prospective Randomized Clinical Trial","Inclusion Criteria:\n\n* Under the age of 65 with uni- or bilateral primary breast cancer ( clinical Stage 0-III), needing skin sparing mastectomy, nipple sparing mastectomy or patients require risk reducing mastectomy independently of the axillary surgery, having immediate or delayed-immediate implant based reconstruction.\n\nExclusion Criteria:\n\n* In case the patient does not volunteer for the examination or the follow-ups\n* Age above 65 years or poor general health condition, where the estimated life expectancies would be less than 2 years even without the tumorous disease\n* Malignant invasive tumor in the past history (except for non-melanoma skin tumors)\n* Mastectomy and reconstruction performed due pregnancy associated breast cancer\n* Prior breast surgery (e.g. aesthetic surgery, mastopexy) and\u002For radiotherapy on the breast or in the axilla\n* Malignant tumor is not removed completely with pathological examination\n* Severe non-surgical (e.g. radiotherapy) complication, which could influence the aesthetic and functional results\n* Autoimmune diseases\n* Mastitis carcinomatosa\n* Lymphangitis carcinomatosa\n* Open wound therapy due SSI\n* Long-term steroid usage, which changed the skin's quality and structure\n* Patient under foster care, or psychically non-cooperative patient",{"count":104,"type":21},110,"This is a response-adaptive (RAR) prospective randomized study with a long-term follow-up and the aim of this clinical study is to measure with qualitative and quantitative indicators the changes in cosmetic results, quality of life and patient satisfaction after delayed- immediate breast reconstruction with standardized technique Skin Reducing Nipple sparing mastectomy, SRNSM and SSM with standardized horizontal skin incision.\n\nAccording to our hypothesis, SRNSM with standardized technique on pendulous\u002F ptotic breasts is a safe procedure compared to SSM. It also promotes the cosmetic efficacy of SRNSM with the removal of the entire glandular tissue through avoidance of the reduction of projection, the need later nipple reconstruction surgery and of areola tattoo.\n\nIn our study we propose that compared to one of the well-known and widely investigated studied SSM, our current standardized SRNSM technique is able to perform similar oncologically safe entire gland tissue removal, with low complication rate, accommodating for adjuvant treatments. Furthermore, it may provide superior cosmetic results than SSM (NAC is not removed, projection is maintained, and there is no need for further nipple reconstruction or tattoo) with high patient satisfaction which is maintained long term.",[60,86,87,107],"Patient Satisfaction","2020-04-18",{"date":88,"type":35},{"date":108,"type":35},{"date":112,"type":21},"2027-04-05",{"name":41,"class":42},{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":80,"sex":17,"minAge":52,"maxAge":81,"enrollmentInfo":121,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":127,"leadSponsor":128,"locationsCount":72},"100389334","comparison-of-the-cosmetic-results-quality-of-life-and-patient-satisfaction-achieved-with-round-block-and-retroglandular-oncoplastic-breast-conserving-surgeries-100389334","NCT04349527","Comparison of the Cosmetic Results, Quality of Life and Patient Satisfaction Achieved With Round-block and Retroglandular Oncoplastic Breast Conserving Surgeries","Comparison of the Cosmetic Results, Quality of Life and Patient Satisfaction Achieved With Round-block and Retroglandular Oncoplastic Breast Conserving Surgeries. Response-adaptive (RAR) Prospective Randomised, Comperative Clinical Study","Inclusion Criteria:\n\n* \\- Under the age of 65, suffering from unilateral (cT\\\u003C 3cm) in situ or invasive breast cancer, who are fit for breast conserving surgeries, who had no previous breast surgery, independent from axillary surgery (sentinel lymph node biopsy or axillary block dissection)\n\nExclusion Criteria:\n\n* In case the patient does not volunteer for the examination or the follow-ups\n* Age above 65 years or poor general health condition, where the estimated life expectancies would be less than 2 years even without a tumor\n* Malignant invasive tumor in the past history (except for non-melanoma skin tumors)\n* Mastectomy performed due to positive resection margin\n* Prior breast surgery (e.g. aesthetic surgery, breast lift) and\u002For radiotherapy on the breast or in the axilla\n* Malignant tumor is not removed completely with pathological examination\n* Severe non-surgical (e.g. radiotherapy) complication, which could influence the aesthetic and functional results\n* Autoimmune diseases\n* Tumor requiring mastectomy, or clinically larger than 3 cm tumor primary, or mastitis carcinomatosa, lymphangitis carcinomatosa\n* Long-term steroid usage, which changed the skin's quality and structure\n* Patient under foster care, or psychically non-cooperative patient",{"count":122,"type":21},242,"The aim of this clinical study is to analyze due long term follow-up, the clinical, oncological, aesthetic results and patients' reported quality of life and satisfaction in a responsive-adaptive (RAR) prospective, randomized study at a large number of patients whom receive round-block and retroglandular oncoplastic breast conserving surgeries.\n\nAccording to the study's hypothesis, breast conserving surgery can be oncologically successful and safe with low complication rates resulting in high rate of patient satisfaction and good quality of life, which can be maintained for a long time after WBI with the application of modern oncoplastic breast conserving surgeries. We assume in this study that against of the earliest and mostly studied round-block oncoplastic surgery, the retroglandular technique, firstly reported in the literature by the current authors, is also adequate for oncologically safe, radical tumor removal that comes with low complication rates, suited for adjuvant treatments and able to offer better cosmetic results (NAC does not distorted, and pathological scar will not develop) than round-block OPS and high rate of patient's satisfaction that can be maintained for long-term.",[60,87,107],{"date":88,"type":35},{"date":108,"type":35},{"date":112,"type":21},{"name":41,"class":42},""]