Baricitinib in Idiopathic Granulomatous Mastitis

Idiopathic Granulomatous Mastitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05852171
• Other study ID #: ZYYY-IGM-001
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2023
• Est. completion date: October 31, 2025

Study information

• Verified date: April 2023
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Zefeng Xuan, Doctor
• Phone: 18100189899
• Email: xuanzefeng[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

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.

Related Conditions & MeSH terms

• Granulomatous Mastitis
• Idiopathic Granulomatous Mastitis
• Mastitis

Intervention

Drug:
• Baricitinib
Baricitinib administered orally

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Degree of inflammation markers change	Determination the concentration of inflammation markers, such as TNF-a, IL-6, IL-17a and CRP, in serum at different time points after baricitinib administered orally.	Until progression, assessed up to approximately 24 months
Secondary	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