[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"granulomatous-mastitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:granulomatous-mastitis":161},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,65,107,134],{"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":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100637079","phase-1-tocilizumab-for-the-treatment-of-refractory-granulomatous-lobular-mastitis-100637079",false,"NCT07595900","Tocilizumab for the Treatment of Refractory Granulomatous Lobular Mastitis","Efficacy and Safety of Tocilizumab in the Treatment of Refractory Granulomatous Lobular Mastitis: A Two-Center, Single-Arm Clinical Trial","Inclusion Criteria:\n\n1. Females aged 20 to 50 years;\n2. Clinically diagnosed (combined with pathology) with non-lactational granulomatous mastitis (cessation of lactation for more than 6 months);\n3. M-Activity-Score ≥ 2;\n4. Steroid-refractory NL-GLM or intolerant to steroid therapy.\n5. Female subjects of childbearing potential agree to use highly effective contraception starting at least 7 days before the first dose until 16 weeks after dosing. Pregnancy tests for female subjects of childbearing potential must be negative within 7 days before the first dose.\n\nExclusion Criteria:\n\n1. Bilateral mastitis occurring simultaneously or sequentially within six months.\n2. Clinical diagnosis (combined with pathological findings) of periductal mastitis.\n3. History of lymphoproliferative disorder; or presence of signs or symptoms suggestive of a possible lymphoproliferative disorder (including lymphadenopathy or splenomegaly); or active primary or recurrent malignancy; or clinically significant malignancy with a remission duration of less than 5 years.\n\n   1. Patients with carcinoma in situ of the cervix may participate if successfully treated with no evidence of recurrence or metastasis for at least 3 years.\n   2. Patients with basal cell or squamous cell carcinoma of the skin may participate if successfully treated with no evidence of recurrence for at least 3 years.\n4. Patients who are pregnant.\n5. Current or recent severe viral, bacterial, fungal, or parasitic infection, including but not limited to:\n\n   1. Symptomatic herpes zoster infection within 12 weeks prior to screening.\n   2. History of disseminated\u002Fcomplicated herpes zoster (e.g., multidermatomal involvement, herpes zoster ophthalmicus, CNS involvement, or postherpetic neuralgia).\n   3. Symptomatic herpes simplex at the time of enrollment.\n   4. Active or chronic infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n   5. Household contact with an individual with active tuberculosis (TB) and not having received appropriate and documented TB prophylaxis.\n   6. Evidence of active TB, or history of active TB without appropriate and documented treatment.\n   7. Clinically significant infection within 4 weeks prior to enrollment, or having received intravenous antibiotic therapy for an infection.\n   8. Any other active or recent infection within 4 weeks prior to enrollment that, in the investigator's judgment, would pose an unacceptable risk to the patient.\n\n   Note: Recent viral upper respiratory tract infections or uncomplicated urinary tract infections should not be considered clinically significant.\n6. Patients with hepatic or renal insufficiency, gastrointestinal ulcer, active hepatitis, active rheumatic autoimmune disease, active tuberculosis, or poorly controlled psychiatric disorders.\n7. Cardiac, pulmonary, hepatic, renal, or coagulation dysfunction that, in the investigator's judgment, makes the patient unsuitable for enrollment.\n8. History of hypersensitivity to tocilizumab.\n9. Previous treatment with tocilizumab (a single prior dose may be exempted upon investigator's assessment).\n10. Any major surgery within 8 weeks prior to screening, or requirement for major surgery during the study period, which, in the investigator's judgment, would pose an unacceptable risk to the patient.\n11. Presence of the following laboratory abnormalities, or any other laboratory value outside the reference range deemed by the investigator to pose an unacceptable risk for participation:\n\n    1. AST or ALT ≥ 2 × upper limit of normal (ULN)\n    2. Alkaline phosphatase (ALP) ≥ 2 × ULN\n    3. Total bilirubin (TBL) ≥ 1.5 × ULN\n    4. Hemoglobin \\\u003C 9.0 g\u002FdL\n    5. Total white blood cell count \\\u003C 2.5 × 10⁹ cells\u002FL\n    6. Neutropenia (absolute neutrophil count \\[ANC\\] \\\u003C 1.2 × 10⁹ cells\u002FL)\n    7. Lymphopenia (lymphocyte count \\\u003C 0.75 × 10⁹ cells\u002FL)\n    8. Thrombocytopenia (platelets \\\u003C 100 × 10⁹\u002FL)\n    9. Estimated glomerular filtration rate (eGFR) \\\u003C 40 mL\u002Fmin\u002F1.73 m² (based on the CKD-EPI equation) Note: The above abnormalities may be retested during the screening period, with eligibility determined based on the retest results.\n12. Administration of a live or attenuated vaccine within 6 weeks prior to the first dose, or planned administration during the treatment period or within 6 weeks after the last dose.\n13. Body weight ≥ 100 kg.","FEMALE","20 Years","50 Years",{"count":20,"type":21},31,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Non-Lactational Granulomatous Lobular Mastitis (NL-GLM) is an inflammatory disease of unknown etiology, characterized clinically by local breast masses, accompanied by redness and swelling of the overlying skin, sinus tract formation, and other symptoms. Currently, there is no universally accepted standard treatment for this condition; previous expert consensus or practice guidelines have mostly recommended systemic glucocorticoid therapy as the primary treatment approach. Our team's preliminary research has confirmed that local glucocorticoid injection achieves efficacy equivalent to systemic administration but with better safety, making it a first-line treatment option for NL-GLM. However, in our preliminary studies and literature reports, we found that some patients still exhibit glucocorticoid dependence or resistance (i.e., refractory NL-GLM) after receiving either local or systemic glucocorticoid therapy. The lack of high-quality evidence to support subsequent-line treatments has become a major bottleneck in clinical management. Additionally, some patients cannot tolerate glucocorticoid therapy due to its adverse effects. Research has shown that the IL-6 inflammatory pathway is significantly activated in the lesion tissues and peripheral blood of NL-GLM patients, and the IL-6 inhibitor tocilizumab has demonstrated efficacy in various autoimmune diseases. Based on this, this study intends to conduct a dual-center, single-arm clinical trial to systematically evaluate the efficacy and safety of tocilizumab in the treatment of refractory NL-GLM. The aim is to fill the treatment gap, provide high-level evidence for clinical practice, and ultimately improve patient outcomes.",[28,29],"Granulomatous Lobular Mastitis","Granulomatous Mastitis","NOT_YET_RECRUITING","2026-05-13",{"date":33,"type":34},"2026-05-19","ACTUAL",{"date":36,"type":21},"2026-06-01",{"date":38,"type":21},"2028-10-30",{"name":40,"class":41},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":64},"100627910","phase-1-antibiotics-vs-corticosteroids-in-treatment-of-granulomatous-lobular-mastitis-100627910","NCT07454772","Antibiotics vs Corticosteroids in Treatment of Granulomatous Lobular Mastitis","Antibiotics vs Corticosteroids in Treatment of Granulomatous Lobular Mastitis - A Randomized Controlled Trail","GRANMAS","Inclusion Criteria:\n\n* Women histologically diagnosed with GLM willing to participate in the study and to come for follow up.\n\nExclusion Criteria:\n\n* Declining to participate in the study\n* Pregnant or lactating women\n* Patient already on antibiotic\u002Fsteroid therapy and are responding to treatment\n* Known immunosuppression or diabetes mellitus uncontrolled\n* Patient already on immunosuppression therapy for any other disorder\n* Lost to follow-up before 3 months post-treatment\n* Allergic to one of the antibiotics\u002Fsteroids which will be used\n* Contraindications to oral steroids therapy\n* Contraindications to methotrexate therapy",{"count":51,"type":21},72,[24,25],"The goal of this clinical trial is to find the most effective and safe medical treatment for Granulomatous Lobular Mastitis (GLM) - a rare, chronic inflammatory breast disease that affects young and middle-aged women, often following childbirth.\n\nThe main questions it aims to answer are:\n\nDoes an antibiotic regimen (clarithromycin, ofloxacin, rifaximin) lead to faster and complete healing (Complete Clinical Response) compared to steroids?\n\nDo steroids (prednisolone in tapering doses) provide better symptom control or cause more side effects?\n\nResearchers will compare the antibiotic group (Group A) and the steroid group (Group B) to see which treatment results in quicker recovery, fewer side effects, and lower recurrence rates.\n\nParticipants will:\n\nReceive a 14-day antibiotic trial initially (screening phase).\n\nIf no improvement, be randomly assigned to:\n\nGroup A (Antibiotic therapy) - Clarithromycin, Ofloxacin, Rifaximin for 8 weeks, or\n\nGroup B (Steroid therapy) - Prednisolone in tapering doses for 8 weeks.\n\nUndergo evaluation after 2 months:\n\nIf not fully recovered, receive Methotrexate + Folic acid for another 8 weeks.\n\nIf still no improvement, switch to the alternate treatment or undergo surgery if required.\n\nAttend regular follow-ups for 6 months for clinical assessment and monitoring of side effects.\n\nThis 2-year study aims to develop a standardized, step-by-step treatment protocol for GLM, helping improve outcomes and reduce unnecessary surgeries for affected women.",[29],"2026-03-04",{"date":57,"type":34},"2026-03-06",{"date":59,"type":21},"2026-03-15",{"date":61,"type":21},"2027-07-04",{"name":63,"class":41},"All India Institute of Medical Sciences, Bhubaneswar",1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":73,"minAge":74,"maxAge":4,"enrollmentInfo":75,"targetDuration":77,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":106},"100625456","granulomatous-mastitis-registry-study-100625456","NCT07422870","GRAnulomatous MAstitis REGistry Study","A Retrospective \u002F Prospective Cohort Study to Evaluate the Incidence, Diagnostic Features, Clinical Course and Treatment Strategies in Histologically Confirmed Idiopathic Granulomatous Mastitis","GRAMAREG","Inclusion Criteria:\n\n* Histologically confirmed idiopathic granulomatous mastitis OR cystic neutrophilic granulomatous mastitis by local pathology (minimally invasive biopsy or histological confirmation on surgical specimen)\n* First histological confirmation after January 1, 2015\n* Female or male patients ≥18 years old\n* Signed informed consent form for all patients included in prospective part of the study (patients presenting with idiopathic granulomatous mastitis after activation of the study at Study Site)\n\nExclusion Criteria:\n\n* Patients with suspicion of idiopathic granulomatous mastitis but without histological confirmation\n* Suspicion of OR confirmed secondary granulomatous mastitis due to:\n* Tuberculosis, Sarcoidosis, Fungal infection, Parasitic infection, Foreign body reaction","ALL","18 Years",{"count":76,"type":21},1000,"5 Years","OBSERVATIONAL","Idiopathic granulomatous mastitis (IGM) is a rare benign inflammatory breast condition with unknown cause, affecting approximately 2.4 per 100,000 women aged 20-40 years. Patients experience severe local symptoms including pain, redness, and recurrent abscesses that can last weeks to months and often mimic inflammatory breast cancer. Due to its rarity, mostly case reports and case series exist in the literature, leading to limited knowledge about risk factors, optimal treatment strategies, and clinical outcomes.\n\nThe GRAMAREG study is the first European registry for patients with histologically confirmed idiopathic granulomatous mastitis. This retrospective\u002Fprospective observational cohort study aims to systematically evaluate the incidence, diagnostic features, clinical course, treatment strategies, and patient outcomes of this uncommon disease. The study collects both retrospective data (from January 1, 2015 onwards) and prospective data from participating sites across Europe.\n\nAll diagnostic and therapeutic procedures are conducted according to institutional standards in clinical routine, as this is a non-interventional study. Patients in the prospective cohort are followed for up to 5 years to document symptom duration and recurrence rates.",[81,29],"Idiopathic Granulomatous Mastitis",[83,84,85,86,87,88,89,90,91,92,93,94,95],"Idiopathic granulomatous mastitis","IGM","Granulomatous mastitis","Cystic neutrophilic granulomatous mastitis","CNGM","Inflammatory breast disease","Benign breast disease","Chronic mastitis","Non-lactational mastitis","Breast inflammation","Patient registry","Cohort study","granulomatous lobular mastitis","2026-02-26",{"date":98,"type":34},"2026-02-27",{"date":100,"type":21},"2026-04-01",{"date":102,"type":21},"2036-04-01",{"name":104,"class":105},"European Breast Cancer Research Association of Surgical Trialists","NETWORK",2,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":74,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":64},"100570844","effect-of-different-surgical-approaches-of-granulomatous-mastitis-100570844","NCT06712524","Effect of Different Surgical Approaches of Granulomatous Mastitis","A Prospective Real-world Study of the Effect of Different Surgical Approaches on the Recurrence Rate and Aesthetic Outcome of Granulomatous Mastitis","Inclusion Criteria:\n\nOnly the subjects who meet all the following criteria may be included in this study:\n\n1. Ability to understand the study procedures and contents, and willingness to voluntarily sign the written informed consent form;\n2. 18≤Age≤75 years old, female;\n3. Histologically confirmed granulomatous mastitis;\n4. low and moderate risk for anesthesia.\n\nExclusion Criteria:\n\nThe subjects who meet any of the following criteria shall not be included in this study:\n\n1. Absolute and relative contraindication for surgery;\n2. Previous history of breast cancer or other malignancies;\n3. Pregnancy;\n4. Any serious complications which caused patients not suitable to participate this study.",{"count":115,"type":21},240,[117],"NA","The objective of this study was to prospectively investigate the effects of different surgical approaches on the recurrence rate and aesthetic outcome of patients with granulomatous mastitis. The patients were divided into traditional surgery group and plastic surgery group.",[120,29],"Breast-conserving Plastic Surgery",[85,122,123],"breast conserving plastic surgery","Aesthetics scores","RECRUITING","2024-11-26",{"date":127,"type":34},"2024-12-02",{"date":129,"type":34},"2024-11-01",{"date":131,"type":21},"2027-12-31",{"name":133,"class":41},"Hubei Cancer Hospital",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":145,"conditions":146,"keywords":147,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":64},"100559570","analysis-of-various-treatment-methods-of-granulomatous-lobular-mastitis-100559570","NCT06565845","Analysis of Various Treatment Methods of Granulomatous Lobular Mastitis","Analysis of the Clinical Characteristics and Three Treatment Methods of Granulomatous Lobular Mastitis","Inclusion Criteria:\n\n* non-lactating and aged 15-65 years\n* histopathological confirmation of GLM\n* normal liver and kidney function\n\nExclusion Criteria:\n\n* lactating and pregnant women\n* allergies to rifampin, isoniazid, or ethambutol\n* concurrent malignant breast tumors\n* severe underlying diseases\n* other conditions deemed unsuitable by the investigator and\n* refusal to participate in the study","15 Years","65 Years",{"count":144,"type":21},350,"Granulomatous lobular mastitis (GLM) is a rare benign breast disease that is difficult to distinguish from breast cancer based on clinical and imaging findings, and there is currently no standard treatment. This study aims to analyze the clinical characteristics and demographic data of GLM patients and to compare the overall effectiveness of three treatment methods: surgery alone, triple anti-tuberculosis drug therapy alone, and combined surgery with triple anti-tuberculosis drug therapy, with the goal of providing new insights for clinical treatment.",[29],[148,149,150,151],"Granulomatous lobular mastitis","surgical treatment","antituberculosis therapy","surgery combined with anti-tuberculosis therapy","2024-08-21",{"date":154,"type":34},"2024-08-22",{"date":156,"type":34},"2024-08-19",{"date":158,"type":21},"2024-10-19",{"name":160,"class":41},"First Affiliated Hospital of Harbin Medical University","Granulomatous, Mastitis"]