Granulomatous, Mastitis

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.

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. The main questions it aims to answer are: Does an antibiotic regimen (clarithromycin, ofloxacin, rifaximin) lead to faster and complete healing (Complete Clinical Response) compared to steroids? Do steroids (prednisolone in tapering doses) provide better symptom control or cause more side effects? Researchers 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. Participants will: Receive a 14-day antibiotic trial initially (screening phase). If no improvement, be randomly assigned to: Group A (Antibiotic therapy) - Clarithromycin, Ofloxacin, Rifaximin for 8 weeks, or Group B (Steroid therapy) - Prednisolone in tapering doses for 8 weeks. Undergo evaluation after 2 months: If not fully recovered, receive Methotrexate + Folic acid for another 8 weeks. If still no improvement, switch to the alternate treatment or undergo surgery if required. Attend regular follow-ups for 6 months for clinical assessment and monitoring of side effects. This 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.

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. The GRAMAREG study is the first European registry for patients with histologically confirmed idiopathic granulomatous mastitis. This retrospective/prospective 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. All 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.

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.

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.