Baricitinib in Idiopathic Granulomatous Mastitis

• Status: Recruiting
• Trial end date: 2025-10-31
• Target enrollment: 0
• Participant gender: Female

Summary

This study will explore the mechanism of targeted drug in treatment of idiopathic granulomatous mastitis, and clarify the clinical classification and corresponding markers.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Criteria

Inclusion Criteria:

• Patients must be between 18 years of age and 70 years of age

• Female patients who have pathologically documented idiopathic granulomatous mastitis that:

1. Non-lactating mastitis

2. Core needle biopsy pathology to indicate mastitis or biopsy pathology of palpable mass indicates chronic interstitial cell infiltration.

3. Special immunohistochemical is negative [Acid fast dyeing, Mayer's dyeing, PAS, fungi (FISH), Tuberculosis (FISH), hexamine silver], excluding the possibility of infection such as fungi, tuberculosis or other corynebacterium.

• Measurable lesions are required(mainly breast ultrasound can detect lesion with low echo).

• ECOG Performance Status of 0 or 1,Karnofsky score is greater than 80

Exclusion Criteria:

• Pregnant women, lactating women or those who have a fertility plan within 3 years; Informed consent does not meet the requirements (if it is not in person, and the authorization consent is missing).

• Core needle biopsy pathology indicates that inflammation caused by tuberculosis and other pathogenic bacteria infection or any of the above immunohistochemical staining items are positive; Lung (HR) CT showed that tuberculosis or tumor could not be excluded; Misdiagnosis; No test record; There is no record of return visit.

• Due to the use of other potential therapeutic drugs, such as glucocorticoids or anti-tuberculosis drugs, the effectiveness evaluation of baricitinib cannot be carried out; Those who have been diagnosed as malignant tumors, have been treated or are being treated; Those who have serious complications, such as cardiac or pulmonary insufficiency, severe cerebral infarction, and cannot tolerate the treatment.