Baricitinib in Idiopathic Granulomatous Mastitis

NCT05852171 | Active Not Recruiting Phase 2

• 1 other identifier: ZYYY-IGM-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mastitis Chronic; Idiopathic Granulomatous Mastitis

Keywords

Baricitinib

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective response rate (ORR) was defined as the sum of complete response rate (CR) and partial response rate (PR). The largest IGM lesion was evaluated using breast ultrasound (BUS) according to RECIST v1.1 in two dimensions: length ("LGH" in cm) and height ("HGT" in cm). CR was defined as the complete resolution of target lesion confirmed by both physical examination (PE) and BUS, complete healing of skin ulcerations and sinuses, and normalization of 12 inflammatory biomarkers. PR required ≥50% reduction in abnormal inflammatory markers accompanied by at least one of the following criteria: (1) clinical improvement in erythema, edema, local hyperthermia, or pain; (2) ≥50% reduction in LGH or HGT measured by BUS; or (3) ≥75% healing of skin ulcerations and sinuses.

  Until progression or recurrence, assessed up to approximately 24 months post-intervention

Secondary Outcomes (2)

• 12-month recurrence rate

  Until progression, assessed up to approximately 24 months post-intervention

• Toxicity and side effects

  Up to follow-up period, approximately 24 months post-intervention

Study Arms (1)

Baricitinib

EXPERIMENTAL

Baricitinib，2mg QD，oral use.

Drug: Baricitinib

Interventions

Baricitinib DRUG

Baricitinib administered orally

Also known as: Olumiant, Baricinix

Baricitinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are willing to participate in clinical research; females; age 18-70 years; KPS\>80%, ECOG\<2; non-lactating mastitis; core needle biopsy pathology suggests mastitis or (if there is a palpable lump, biopsy pathology suggests) interstitial chronic cell infiltration. At the same time, the special staining of immunohistochemistry is negative \[anti-acid, mucicarmine, PAS, fungi (FISH), TB (FISH), methenamine silver\], and the possibility of infection with fungi, Mycobacterium tuberculosis or other rod bacteria is ruled out via DNA sequencing using fresh tissue taken from IGM lesions; measurable lesions (mainly low echo lesions detectable by breast ultrasound).

You may not qualify if:

• Related to subjects:
• Pregnant, breast-feeding, or women planning to have children within 3 years; informed consent does not meet the requirements (if not the patient herself, authorization consent form is missing).
• Relevant to the disease:
• Core-needle biopsied pathology suggests inflammation caused by pathogens such as tuberculosis or other bacteria, or any item tested positive in the above immunohistochemistry; lung (HR) CT suggests that tuberculosis or tumor cannot be ruled out; Misdiagnosis; No testing records available; No revisit records available.
• Unable to conduct an efficacy evaluation due to the use of other potential therapeutic drugs, such as glucocorticoids or antituberculosis drugs; Confirmed malignant tumors, those under treatment or after treatment; With severe complications such as cardiac or pulmonary insufficiency, severe cerebral infarction, etc., unable to tolerate treatment.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Interventions

baricitinib

Study Officials

• Haiyan Wei, Doctor

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. At least 20 patients are planned to be enrolled, and the objective response rate including clinical complete remission rate and partial response rate is the main endpoint.This study will also assess the degree of focus reduction, the recurrence rate within 12 months after drug termination, the degree of inflammation markers decline, and the toxicity and side effects of the drug.

Study Record Dates

• First Submitted: April 23, 2023
• First Posted: May 10, 2023
• Study Start: May 4, 2023
• Primary Completion: April 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 14, 2025

Record last verified: 2024-05

Locations

CN (1)