[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,44,69,92,124,154],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100621394","effect-of-topical-oxygen-and-led-light-therapy-on-nipple-crack-100621394",false,"NCT07370051","Effect of Topical Oxygen and LED Light Therapy on Nipple Crack","Effect of Topical Oxygen and LED Light Therapy on Nipple Crack: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Individuals aged 18-40,\n* Those who gave birth at term (37-42 weeks),\n* Those whose baby was 0-28 days old at the first visit,\n* Those diagnosed with nipple fissures,\n* Breastfeeding their baby,\n* Those who have had a single birth,\n* Those without a diagnosis of psychiatric illness and who are not taking related medication.\n\nExclusion Criteria:\n\n* Those with infection, mastitis, abscess, etc. accompanying nipple injury,\n* Those who have started medical treatment for nipple injury,\n* Those who are unable to continue breastfeeding,\n* Those who feed their baby by expressing breast milk,\n* Those who show any adverse reaction to photosensitivity or exposure to sunlight.","FEMALE","18 Years","40 Years",{"count":20,"type":21},51,"ESTIMATED","INTERVENTIONAL",[24],"NA","The World Health Organization and UNICEF define the protection and support of breastfeeding as one of the key determinants of maternal and newborn health. Nipple cracks are common in the postpartum period and cause breastfeeding problems. If not addressed early, they can lead to interrupted or complete cessation of breastfeeding. It is important to develop methods for effective, safe, and mother-friendly care of nipple cracks. Various care approaches, such as lanolin, natural products, and hydrogels, have been described in the literature. However, evidence for non-invasive agents that support wound healing at the cellular level is limited. Evidence for LED light application is limited, and there is no evidence regarding the effect of topical oxygen application on nipple cracks.\n\nThis project is designed as a randomized controlled trial to investigate the effect of topical oxygen and LED light therapy applied to nipple cracks on wound healing, pain, and breastfeeding success. The study will be conducted at the Lactation Unit of Istanbul Haseki Training and Research Hospital, Ministry of Health, between March and December 2026. The sample size was calculated using the G\\*Power program; with an effect size of 0.20, a significance level of 5%, and a power of 80%, a total of 51 mothers will be included in the study. Participants will be divided into three groups using the block randomization method: Topical Oxygen (n=17), LED Light Therapy (n=17), and Control (n=17). Standard breastfeeding counseling will be provided to all groups. In addition to the intervention groups, topical oxygen will be applied at a flow rate of 10 liters per minute for 20 minutes; LED light therapy will be applied at 630 nm red and 850 nm infrared wavelengths, at an energy dose of 15.3 J\u002Fcm², for 5 minutes. Interventions will be performed on days 0, 3, and 7. Data will be collected using a personal information form, wound size measurement, Nipple Trauma Score, Visual Analog Scale, and LATCH score. The validity and reliability of the Nipple Trauma Score in Turkish will be assessed within the scope of the project.\n\nTo reduce measurement and analysis bias, support will be obtained from an independent observer and a statistician.",[27,28,29,30],"Breastfeeding","Newborn Infant","Midwifery","Breast","NOT_YET_RECRUITING","2026-05-23",{"date":34,"type":35},"2026-05-27","ACTUAL",{"date":37,"type":21},"2026-09-15",{"date":39,"type":21},"2027-04-15",{"name":41,"class":42},"Istanbul University - Cerrahpasa","OTHER",1,{"id":45,"slug":4,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100375917","NCT04174742","Self Reported Pain in Women While Undergoing Treatment for Non-metastatic Breast Cancer","Self-Reported Pain and Nadir White Blood Cell\u002FAbsolute Neutrophil Count in Women 45 and Under Compared to Older Women Receiving Pegfilgrastim (or Biosimilar Substitution) While Undergoing Chemotherapy for Non-Metastatic Breast Cancer","Inclusion Criteria\n\nSubject must meet all the following applicable inclusion criteria to participate in this study:\n\n1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Age ≥ 18 years at the time of consent\n3. Female\n4. Histological or cytological confirmation of invasive breast cancer.\n5. Planned to undergo adjuvant or neoadjuvant chemotherapy treatment for invasive breast cancer AND pegfilgrastim (or biosimilar substitution) treatment for neutropenic prophylaxis.\n6. Ability to read and understand the English and\u002For Spanish language\n7. As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study\n\nExclusion Criteria\n\nSubjects meeting any of the criteria below may not participate in the study:\n\n1. Uncontrolled intercurrent illness\u002Fmedical condition or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements as determined by the investigator\n2. Have previously received chemotherapy or radiation other than the first cycle of the planned adjuvant or neoadjuvant chemotherapy as indicated in Inclusion #5\n3. Taking chronic narcotics, as determined by treating physician\n4. Diagnosis of distant metastatic breast cancer\n5. Diagnosis of a chronic pain syndrome (e.g. fibromyalgia, severe osteoarthritis, etc.)\n6. A baseline ESAS pain score of greater than 8.",{"count":51,"type":21},115,"OBSERVATIONAL","The overall purpose of this study is to investigate whether younger subjects report pain with pegfilgrastim (or biosimilar substitution) more often and\u002For at higher levels (greater intensity) than older subjects.This study will be carried out throughout the course of your chemotherapy treatment, which will be prescribed by your study doctor. Participation in this study will not affect your cancer treatment.",[30,55],"Breast Cancer",[57],"Pain","RECRUITING","2026-05-21",{"date":61,"type":35},"2026-05-26",{"date":63,"type":35},"2019-12-17",{"date":65,"type":21},"2041-01",{"name":67,"class":42},"Wake Forest University Health Sciences",2,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":43},"100545466","a-bionic-breast-project-using-neuroprosthesis-to-reduce-chronic-pain-after-mastectomy-100545466","NCT06382272","A Bionic Breast Project Using Neuroprosthesis to Reduce Chronic Pain After Mastectomy","Bionic Breast Project: A Neuroprosthesis to Restore Touch Sensation and Reduce Chronic Pain After Mastectomy","Inclusion criteria:\n\n* 18 years of age or older\n* Scheduled for bilateral mastectomy with two-stage (tissue expander) reconstruction at UCM\n* Bilateral mastectomy for unilateral in situ or T1to T2, clinically, N0 (no lymph node involvement) breast cancer or breast cancer risk reduction due to known elevated breast cancer risk. (Note - 19-34% of women choosing mastectomy for small unilateral breast cancer elect bilateral mastectomy.)40 We will enroll from this cohort.\n* Agrees to have breast tissue expander removed within 12-20 weeks of implantation.\n* Has access to a cell phone and willing to provide the research interviewer with the cell phone number\n* Agrees to receive text messages from the study\n* Able to speak and understand English or Spanish\n* Able to participate in the informed consent process\n\nExclusion criteria:\n\n* Requires adjuvant chemotherapy\n* Single stage mastectomy and reconstruction procedure\n* Clinical evidence of bilateral breast cancer\n* Clinical evidence of lymph node involvement\n* Prior history of mastectomy or other major breast surgery\n* Prior history of radiation to the chest area (e.g., mantle radiation for Hodgkin's disease)\n* Prior history of injury (e.g., trauma, surgery, burn) that the participant perceives to have had an effect on the sensation of the breast\n* Pregnant or intending to become pregnant during the study period\n* Pacemaker, defibrillator or other implanted electrical stimulation device that may be affected by the implanted electrodes\n* Complex regional pain syndrome or other pain syndromes or a history of a neurologic condition like multiple sclerosis, degenerative neurological disease, cognitive impairment or dementia\n* Uncontrolled diabetes\n* History of poor wound healing or chronic skin ulcerations\n* History of uncontrolled infection or active infection at time of consent\n* Expectation that MRI will be required while the devices are implanted\n* Inability or unwillingness to follow verbal instructions and comply with study procedures\n* Untreated or poorly managed physical or mental health condition that may pose additional risk according to clinical judgment of the patient's breast surgeon or surgeons\n* Unwillingness to undergo psychological evaluation to determine study eligibility, if requested or required by surgeons or investigators",{"count":77,"type":21},8,[24],"This trial seeks to establish whether or not touch sensation can be restored to the breast via neural stimulation. Data will also be obtained to inform future feasibility (including safety), efficacy, and acceptability trials.",[81,30,82],"Mastectomy","Chronic Pain","2026-04-22",{"date":85,"type":35},"2026-04-27",{"date":87,"type":35},"2025-05-14",{"date":89,"type":21},"2028-01-31",{"name":91,"class":42},"University of Chicago",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":68},"100522499","early-breast-growth-in-girls-aged-6-to-8-years-in-the-current-environmental-context-100522499","NCT06083415","Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context","Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context: Clinical and Biological Parameters, Level of Impregnation With Endocrine Disruptors and Evaluation of the Impact of Environmental Health Measures","PENELOPE","For patients:\n\nInclusion Criteria:\n\n* Girls aged 6 to 8 years\n* Presenting a breast development (isolated or not)\n* Undergoing scheduled pediatric day hospital care (HDJ)\n* Who agree to participate in the study\n* Whose parents agree to their child's participation in the study\n* French speaking\n* Whose parents speak French\n* Affiliated to social security\n\nExclusion Criteria:\n\n* Organic brain causes of precocious puberty: History of neurocerebral disease (malformations, developmental abnormalities)\n* Organic causes of precocious puberty: Mac Cune Albright syndrome, ovarian cyst or tumor and adrenal hyperplasia\n* History of chemotherapy or radiation therapy\n* Presenting with a communication disorder\n* Pregnancy\n* Persons under protective measures\n* Persons deprived of liberty for judicial or administrative reasons\n\nFor controls:\n\nInclusion Criteria:\n\n* Girls aged 6 to 8\n* Tanner stage 1: Absence of breasts and hairiness\n* Coming for routine consultation in the pediatric HDJ at Saint-Vincent-de-Paul hospital, or at the BLM practice in Lambersart, or to radiology for an MRI for another medical other medical reason\n* Agree to participate in the study\n* Whose parents agree to their child's participation in the the study\n* French-speaking\n* Whose parents speak French\n* Affiliated with social security\n\nExclusion Criteria:\n\n* Signs of puberty (Tanner stages 2, 3, 4 and 5 for breast development) breast development)\n* Previous chemotherapy or radiotherapy\n* Presenting a communication disorder\n* Pregnant women\n* Persons under protective supervision\n* Persons deprived of their liberty for judicial or administrative reasons","6 Years","8 Years",{"count":103,"type":21},62,[24],"Various studies show an increase in the number of cases of early puberty in girls with breast development with a variable clinical presentation and evolution. This increasing phenomenon concerns girls between 6 and 8 years old. In a large number of cases, from 70 to 95% depending on the series, no medical cause is found and environmental factors are suspected to be involved.\n\nDescriptive studies of these patients are scarce and not always provide an overview of all the parameters in line with the concept of the exposome.\n\nThe PENELOPE clinical trial will allow to analyze a large number of parameters, including the adipose tissue, its metabolism, the endocrine disruptors, and the epigenetic modifications, and to study the impact of environmental health measures in the evolution of these parameters.\n\nThe data from the analyses of the endocrine disruptors of the patients will be explored in parallel in experimental models (amphibians, murine, cellular) in order to test potential mechanistic hypotheses.",[107,30,108],"Puberty, Precocious","Environmental Exposure",[110,111,112,113,114],"Early puberty","Endocrine disruptors","Girls","Breast growth","Environmental Health Measure","2026-03-16",{"date":117,"type":35},"2026-03-17",{"date":119,"type":35},"2023-05-15",{"date":121,"type":21},"2027-05-15",{"name":123,"class":42},"Lille Catholic University",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":131,"minAge":17,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":153},"100388125","phase-1-a-dose-finding-phase-1-of-sarilumab-plus-capecitabine-in-her2neu-negative-metastatic-breast-cancer-and-a-single-arm-historically-controlled-phase-2-study-of-sarilumab-plus-capecitabine-in-stage-i-iii-triple-negative-breast-cancer-with-high-risk-residual-disease-empower-100388125","NCT04333706","A Dose Finding Phase 1 of Sarilumab Plus Capecitabine in HER2\u002FNeu-Negative Metastatic Breast Cancer and a Single-arm, Historically-controlled Phase 2 Study of Sarilumab Plus Capecitabine in Stage I-III Triple Negative Breast Cancer With High-Risk Residual Disease (EMPOWER)","EMPOWER","Inclusion Criteria:\n\n* A. Written informed consent obtained from the subject and the ability for the subject to comply with all the study-related procedures.\n* B. Both males and females ≥ eighteen years of age\n* C. A clinical diagnosis of metastatic triple negative or hormone resistant, Her2\u002Fneu-negative breast cancer that has been confirmed histologically at one point during the course of the disease. TNBC is defined as ER\u002FPR IHC positivity rate of \\\u003C10% and Her2Neu-negative (Phase I only)\n* D. A life expectancy of at least 6 months. (Phase I only)\n* E. Any previous cytotoxic chemotherapy must have been a minimum of 3 weeks prior to study drug administration. There is no limit on the number of prior therapies. For ER\u002FPR-positive tumors, endocrine therapy must have been included in at least one of those prior regimens. Prior capecitabine is allowed only if not given in the treatment regimen immediately prior to the enrollment in this study. (Phase I only)\n* F. A diagnosis of TNBC confirmed histologically and defined as ER\u002FPR IHC positivity rate of \\\u003C10% and Her2\u002Fneu-negative. (Phase II and Parallel Baseline Arm only)\n* G. A pathologic confirmation of stage I, or II, or III breast cancer with less than a complete pCR, defined as the absence of residual invasive cancer in resected breast specimen and sampled lymph nodes with residual noninvasive cancer or in situ disease allowed. (Phase II and Parallel Baseline Arm only)\n* H. Must not have received prior systemic treatment for breast cancer except for those included in the neoadjuvant regimen and the neoadjuvant regimen must not have included capecitabine nor sarilumab. (Phase II and Parallel Baseline Arm only)\n* I. An ECOG Performance Status ≤2.\n* J. Adequate organ function defined as:\n\n  1. Absolute neutrophil count (ANC) \\> 1500\u002Fmcl (use of G-CSF is allowed)\n  2. Platelets ≥ 100,000\u002Fmcl\n  3. Hemoglobin ≥ 9 (pRBC +\u002F- ESA are allowed)\n  4. ALT ≤ 5 x ULN\n  5. AST ≤ 5 x ULN\n  6. Bilirubin ≤ 3 x ULN\n  7. GFR ≥ 30 ml\u002Fmin\n* K. Women of childbearing potential (WOCBP) must be using a highly effective method of contraception to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug to minimize the risk of pregnancy. Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.\n* L. Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug.\n\nExclusion Criteria:\n\n* A. Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 24 weeks after the last dose of study drug.\n* B. Females who are pregnant or breastfeeding.\n* C. History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.\n* D. Hepatitis B infection except for prior vaccination. (Phase I and Phase II only).\n* E. Known history of tuberculosis injection. (Phase I and Phase II only).\n* F. A history of diverticulitis. (Phase I and Phase II only).\n* G. Use of live vaccines within 30 days prior to study treatment due to the risk of infection. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella (MMR), varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed. (Phase I and Phase II only)\n* H. History of other malignancy that in the primary oncologist's estimation has at the time of study participation a higher risk of recurrence or death than the study-related cancer.\n* I. Prisoners or subjects who are involuntarily incarcerated.\n* J. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.\n* K. Subjects demonstrating an inability to comply with the study and\u002For follow-up procedures.","ALL","99 Years",{"count":134,"type":21},65,[136,137],"PHASE1","PHASE2","This study looks to advance a novel and potent strategy to eliminate minimal residual disease (MRD) in triple negative breast cancer (TNBC) present even after multimodal treatment, thereby improving survival and increasing cure rate in this aggressive cancer. Patients with locally advanced TNBC are at high risk of developing lethal metastatic disease within 2 years of diagnosis, especially for those without a pathologic complete response (pCR) after neoadjuvant chemotherapy. The high risk occurs despite surgical excision of the primary tumor and axillary lymph nodes to eliminate residual disease.",[30,140,141,142,143],"Metastatic","Triple Negative","Cancer","Disseminated Tumor Cell","2026-03-06",{"date":146,"type":35},"2026-03-10",{"date":148,"type":35},"2020-09-26",{"date":150,"type":21},"2027-05-03",{"name":152,"class":42},"University of Southern California",3,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":43},"100612392","clinical-translation-research-on-a-multi-omics-breast-cancer-distant-metastasis-prediction-model-empowered-by-artificial-intelligence-100612392","NCT07252986","Clinical Translation Research on a Multi-omics Breast Cancer Distant Metastasis Prediction Model Empowered by Artificial Intelligence","A Multi-omics Breast Cancer Distant Metastasis Prediction Model Empowered by Artificial Intelligence and Its Clinical Translation Research","COMPASS-BC","Inclusion Criteria:\n\n1. Female patients pathologically diagnosed with breast cancer at our hospital or participating centers between January 1, 2000, and December 30, 2028.\n2. Must meet one of the following: 1) Initially diagnosed with breast cancer at our hospital, has developed distant metastasis (liver, bone, lung, or brain), and has a biopsy or surgical specimen from the metastatic site stored at our hospital, with complete clinical information available. 2) Primary tumor specimen is not at our hospital, but a biopsy or surgical specimen from a distant metastatic site (liver, bone, lung, brain) is stored at our hospital.\n\nExclusion Criteria:\n\n1. Concomitant metastatic malignancy from another primary cancer.\n2. Incomplete clinical information.",{"count":163,"type":21},2000,"Breast cancer is one of the most common malignancies in women worldwide, and distant metastasis is the main cause of poor prognosis and death. This project aims to construct a precision prediction system based on multi-omics (digital pathology, immunohistochemistry, proteomics, gene sequencing) and artificial intelligence to predict distant and organ-specific metastasis (bone, lung, liver, brain) in breast cancer, analyze its mechanisms, and provide new solutions for precision medicine.",[30,55,166],"Pathology","2026-02-27",{"date":169,"type":35},"2026-03-03",{"date":171,"type":35},"2025-12-01",{"date":173,"type":21},"2028-12-30",{"name":175,"class":42},"Second Affiliated Hospital, School of Medicine, Zhejiang University"]