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Baricitinib in Idiopathic Granulomatous Mastitis

Recruiting
18 - 70 years of age
Female
Phase 2

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Overview

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

Description

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.

Eligibility

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.

Study details

Mastitis Chronic, Idiopathic Granulomatous Mastitis

NCT05852171

First Affiliated Hospital of Zhejiang University

25 January 2024

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