[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anatomic-stage-0-breast-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anatomic-stage-0-breast-cancer-ajcc-v8":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100527905","phase-2-neurotization-of-the-nipple-areolar-complex-to-restore-sensation-for-patients-with-breast-cancer-undergoing-nipple-sparing-mastectomy-and-reconstruction-100527905",false,"NCT06153836","Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction","Randomized Feasibility Study to Determine the Feasibility of Neurotization of the Nipple Areolar Complex at the Time of Nipple Sparing Mastectomy and Prosthetic Based Reconstruction","Inclusion Criteria:\n\n* Female patients age \\>= 18\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Planned nipple sparing mastectomy (NSM)\n* Ideal NSM candidates would meet the following criteria:\n\n  * Cup size A-C\n  * BMI \\\u003C34\n  * Ptosis grade \\\u003C 2\n  * Clinical stage 0 - T2N0\n  * Final planned implant volume \\\u003C 400cc\n  * Inframammary or lateral mammary incision\n  * Tumor \\> 0.5cm from the nipple areolar complex (NAC)\n  * No prior breast reduction, mastopexy, or periareolar incisions on side of planned NSM\n  * No prior breast radiation on side of planned NSM\n  * Tumor \\\u003C0.5cm from NAC (including suspicious calcifications or MRI enhancement)\n  * No planned post mastectomy radiation (PMRT)\n  * No nicotine use within 4 weeks of surgical date\n\nExclusion Criteria:\n\n* Planned autologous reconstruction (immediate or delayed)\n* Pregnancy","FEMALE","18 Years",{"count":19,"type":20},45,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests the willingness of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized study of NSM with or without neurotization of the nipple areolar complex (NAC). This trial also compares patient reported outcomes, including quality of life and breast and NAC sexual functionality, for patients undergoing NSM with or without neurotization of the NAC. NSM is a standard practice option for patients undergoing preventative mastectomy, but many report dissatisfaction with decreased nipple sensation. Neurotization is a surgical technique using a nerve graft in an attempt to restore NAC sensation. Neurotization during NSM and reconstruction may restore NAC sensation and improve quality of life in breast cancer patients.",[26,27,28],"Anatomic Stage 0 Breast Cancer AJCC v8","Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage IIA Breast Cancer AJCC v8","RECRUITING","2026-08-17",{"date":32,"type":33},"2026-08-19","ACTUAL",{"date":35,"type":33},"2023-12-05",{"date":37,"type":20},"2026-11-10",{"name":39,"class":40},"Mayo Clinic","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":41},"100645793","a-navigation-program-to-improve-survivorship-support-service-participation-among-non-metastatic-breast-cancer-survivors-100645793","NCT07699991","A Navigation Program to Improve Survivorship Support Service Participation Among Non-metastatic Breast Cancer Survivors","Implementation of a Navigation Program for Breast Cancer Survivors","Inclusion Criteria:\n\n* GENERAL INCLUSION (PRIMARY OBJECTIVE): Ages 18+\n* GENERAL INCLUSION (PRIMARY OBJECTIVE): Diagnosed with non-metastatic breast cancer\n* GENERAL INCLUSION (PRIMARY OBJECTIVE): Received care at Stefanie Spielman Breast Center\n* COACHING INCLUSION (SECONDARY OBJECTIVE): Referred patients who fall under any of the following:\n\n  * Black and\u002For Hispanic\n  * Ages ≥ 70\n  * Reside in a ZIP code classified as rural by United States Department of Agriculture (USDA) Rural-Urban Commuting Area (RUCA) codes\n\nExclusion Criteria:\n\n* Metastatic breast cancer at time of referral\n* Prisoners or individuals unable to consent\n* Non-English and non-Spanish speakers",{"count":50,"type":20},330,[52],"NA","This clinical trial studies whether a navigation program improves survivorship support service participation among survivors of breast cancer that has not spread from where it first started (primary site) to other places in the body (non-metastatic). Advances in treatment have caused the number of breast cancer survivors to grow. As this number increases, there are reported unmet supportive care needs in this population, including psychological distress and limitations in physical functioning. To address these needs, many cancer centers offer programming on a variety of topics including psychological services, exercise counseling, and nutrition counseling. Research has shown that while interest in these survivorship programs is high, participation remains low, especially among minority women. Navigation is a healthcare service that is designed to guide a patient through the healthcare system and reduce barriers to timely screening, follow-up, diagnosis, treatment, and supportive care. The navigation program in this trial is specifically focused on helping breast cancer survivors schedule and attend survivorship consultation appointments as well as providing additional support to underserved\u002Fvulnerable patients. A navigation program may be effective in improving survivorship support service participation among non-metastatic breast cancer survivors.",[26,27,55,56,57],"Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage III Breast Cancer AJCC v8","Localized Breast Carcinoma","2026-08-12",{"date":60,"type":33},"2026-08-14",{"date":62,"type":20},"2026-09-01",{"date":64,"type":20},"2027-12-31",{"name":66,"class":40},"Ohio State University Comprehensive Cancer Center",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":41},"100596350","5-strain-probiotic-formulation-in-hr-positive-breast-cancer-receiving-aromatase-inhibitor-to-prevent-bone-loss-100596350","NCT07044310","5-strain Probiotic Formulation in HR-positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss","Phase 2 Trial of 5-Strain Probiotic Formulation in Hormone Receptor-Positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss","Inclusion Criteria:\n\n* Female age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2\n* Histologically confirmed anatomical stage 0-III hormone receptor-positive breast cancer\n* Will be starting on an aromatase inhibitor (letrozole, anastrozole, or exemestane) ± ovarian function suppression (OFS) per treating physician's discretion\n* Absolute neutrophil count (ANC) ≥ 1000\u002Fmm\\^3 (prior to registration)\n* Platelet count ≥ 75,000\u002Fmm\\^3 (prior to registration)\n* Hemoglobin ≥ 9.0 g\u002FdL (prior to registration)\n* Creatinine ≤ 2 x upper limit of normal (ULN) (prior to registration)\n* Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \\[AST\\]) ≤ 2 x ULN (prior to registration)\n* Albumin ≥ 3 g\u002FdL (prior to registration)\n* Willing and able to provide research stool and blood samples\n* Negative serum pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only (\\\u003C 60 years old with intact uterus)\n* Capable of providing valid informed consent\n* Willing to return to enrolling institution for all study visits (blood draws, etc)\n\nExclusion Criteria:\n\n* Requires prolonged systemic antibiotic therapy for other conditions and recent systemic antibiotic ≤ 14 days prior to registration\n* Fecal microbiota transplant (FMT) ≤ 6 months prior to registration\n* FMT with an associated serious adverse event related to the FMT product or procedure\n* Co-morbid systemic illnesses or other severe concurrent diseases which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of over-the-counter probiotics\n* Immunocompromised patients including patients known to be HIV positive or those on chronic steroids \\> 20 mg prednisone a day or prednisone-equivalent. Note: Must be off systemic steroids ≥ 90 days prior to registration. However, topical steroids, inhalants, or steroid eye drops are permitted\n* History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis\n* History of chronic diarrhea\n* History of celiac disease\n* Currently has a colostomy\n* Intraabdominal surgery related to gastrointestinal tract ≤ 60 days prior to registration\n* Evidence of active, severe colitis\n* History of short gut syndrome or motility disorders\n* Requires the daily use of medications to manage bowel hypermotility, such as imodium or lomotil\n* Active autoimmune disease that has required systemic treatment in the ≤ 30 days (i.e., with the use of disease-modifying agents, corticosteroids, or immunosuppressive products) prior to registration. Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment ≤ 30 days prior to registration are not excluded\n* History of osteoporosis or hyperparathyroidism\n* History of untreated vitamin D deficiency\n* Receiving or will receive bisphosphonates during study period (alendronate, risedronate, ibandronate, pamidronate, or zolendronic acid) or denosumab\n* Patients who received oral bisphosphonate within ≤ 12 weeks, intravenous (IV) zoledronic acid (Reclast) ≤ 52 weeks, or denosumab ≤ 24 weeks will also be excluded\n* Known hypersensitivity to any component of study product (including known inulin intolerance)\n* Known hypersensitivity to \\> 4 first-line antimicrobial therapies against akkermansia muciniphila, clostridium beijerinckii, clostridium butyricum, anaerobutyricum hallii, including penicillin, piperacillin, tetracycline, amoxicillin, or ampicillin\n* Known hypersensitivity to \\> 4 first line antimicrobial therapies against bifidobacterium infantis Bi-26TM, including gentamicin, kanamycin, streptomycin, tetracycline, erythromycin, clindamycin, ampicillin, vancomycin\n* Received an experimental product ≤ 30 days prior to registration\n* Receiving or will receive CDK 4\u002F6 inhibitor (abemaciclib, ribociclib, or palbociclib)\n* Received chemotherapy ≤ 30 days prior to registration",{"count":75,"type":20},38,[23],"This phase II trial tests how well a probiotic, WBF-038, works in preventing bone loss in patients with early-stage hormone receptor-positive breast cancer who are starting treatment with aromatase inhibitors. Aromatase inhibitors are a drug that blocks the activity of an enzyme called aromatase, which the body uses to make estrogen in the ovaries and other tissues. Blocking aromatase lowers the amount of estrogen made by the body, which may stop the growth of cancer cells that need estrogen to grow. Aromatase inhibitors are used to treat some types of breast cancer or to keep it from coming back. Aromatase inhibitors can affect bone health, weight, blood sugar, and waist size. WBF-038 is a combination of both prebiotics and probiotics, designed to improve metabolic health. Giving WBF-038 may improve bone turnover, bone health, blood sugar, weight, and waist circumference in patients with early-stage hormone receptor-positive breast cancer starting on adjuvant endocrine therapy with an aromatase inhibitor.",[26,27,55,56,79],"Hormone Receptor-Positive Breast Carcinoma","2026-08-06",{"date":82,"type":33},"2026-08-10",{"date":84,"type":33},"2025-07-25",{"date":86,"type":20},"2027-07-25",{"name":39,"class":40}]