Baricitinib in Idiopathic Granulomatous Mastitis

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

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

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Granulomatous Mastitis; Mastitis Chronic
• Intervention / Treatment: Drug: Baricitinib

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zefeng Xuan, Doctor; Phone Number: 18100189899; Email: xuanzefeng@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The First Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Jiaqi Jiang; Phone Number: 15056602195

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baricitinib; Baricitinib，2mg QD，oral use.	Drug: Baricitinib; Baricitinib administered orally; Other Names: Olumiant; Baricinix

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Investigators: Principal Investigator: Haiyan Wei, Doctor, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): October 31, 2025
• Study Completion (Anticipated): October 31, 2025

Study Registration Dates

• First Submitted: April 23, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Baricitinib
• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases; Pregnancy Complications; Puerperal Disorders; Mastitis; Granulomatous Mastitis
• Other Study ID Numbers: ZYYY-IGM-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No