Baricitinib in Idiopathic Granulomatous Mastitis

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

Detailed Description
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This study is aim to explore the mechanism of baricitinib in regulating the occurrence and development of idiopathic granulomatous mastitis, as well as the clinical classification and potential markers of idiopathic granulomatous mastitis. The target population of interest in this study is patients with non-lactating mastitis, which requires core needle biopsy pathology to indicate mastitis or biopsy pathology of palpable mass indicates chronic interstitial cell infiltration. Measurable lesions are required. The primary end point was the clinical complete remission rate, and the secondary end point was the degree of focus reduction, the recurrence rate within 12 months after drug withdrawal, the degree of inflammation markers decline, and the toxicity and side effects of the drug.

Official Title
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A Prospective Open-label Single-arm Clinical Study of the Efficacy of Baricitinib for Idiopathic Granulomatous Mastitis in a Single Institution

Conditions
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Mastitis Chronic, Idiopathic Granulomatous Mastitis

Intervention / Treatment
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* Drug: Baricitinib


Participation Criteria
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Eligibility Criteria
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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: Non-lactating mastitis Core needle biopsy pathology to indicate mastitis or biopsy pathology of palpable mass indicates chronic interstitial cell infiltration. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This study is a single-center, non-controlled, open-label, prospective single-arm trial (Simon's two-stage design). To evaluate the clinical efficacy and safety of baricitinib for idiopathic granulomatous mastitis. 20 patients will be enrolled, and the clinical complete remission rate is the main endpoint.This study will also assess the degree of focus reduction, the recurrence rate within 12 months after drug withdrawal, the degree of inflammation markers decline, and the toxicity and side effects of the drug.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baricitinib<br>Baricitinib，2mg QD，oral use. | Drug: Baricitinib<br>* Baricitinib administered orally<br>* Other names: Baricinix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Complete Remission Rate(CRR) | CRR defined as the proportion of patients who have a confirmed Complete Remission (CR) , as determined by the investigator at local site per RECIST 1.1.In this study, CR is defined as the complete healing of the lesion and the return of inflammation index to normal level indicated by special physical examination and breast ultrasound. | Until progression or recurrence, assessed up to approximately 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of lesion diameter | The change of lesion diameter is measured by special physical examination and breast ultrasound. | Until progression, assessed up to approximately 24 months | 
| Recurrence rate within 12 months after drug withdrawal | Percentage of patients who recur within 12 months after drug withdrawal. | Until progression or recurrence, assessed up to approximately 12 months after drug withdrawal | 
| Degree of inflammation markers change | Determination the concentration of inflammation markers, such as TNF-α, IL-6, IL-17α and CRP, in serum at different time points after baricitinib administered orally. | Until progression, assessed up to approximately 24 months | 
| Toxicity and side effects of the drug | Occurrence of adverse events (AEs) after baricitinib administered orally according to NCI CTCAE v5.0. | Up to follow-up period, approximately 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Baricitinib