A Phase 2 interventional study of Baricitinib in Mastitis Chronic and Idiopathic Granulomatous Mastitis, sponsored by First Affiliated Hospital of Zhejiang University. Active, not recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by First Affiliated Hospital of Zhejiang University · Phase 2, Interventional, and Treatment
This study will explore the mechanism of targeted drug in treatment of idiopathic granulomatous mastitis, and clarify the clinical classification and corresponding markers.
This study is aimed to explore the treatment effect of baricitinib in idiopathic granulomatous mastitis (IGM), as well as the clinical classification, potential markers and underline etiology of the disease. The target population of interest in this study is patients with non-lactating mastitis, which require core needle biopsy pathology to indicate mastitis without any pathogen infection. When IGM was diagnosed and informed consent complete, low dose of daily 2mg baricitinib was taken orally as the monotherapy in this trial. Follow-up visits were sheduled at baseline (i.e. pretreatment) , 1,3,6 months after treatment, and then every 3 months thereafter until 2 years after treatment discontinuation when achieving complete response. At each follow-up visit, the biggest IGM lesion in each patient was measured by breast ultrasound and 12 inflammational cytokines in peripheral blood should be tested. The primary end point was the objective response rate (ORR) including clinical complete response rate (CR) and partial response rate (PR), and the secondary end point was the recurrence rate within 12 months after drug discontinuation when achieving CR, the degree of inflammation markers decline, and the toxicity and side effects of the drug.
22 studies on the registry are indexed under Granulomatous Mastitis; 7 are open to participants now.
This study's planned enrollment of 20 is below the median of 61 across 12 interventional studies indexed under Granulomatous Mastitis.
Browse Granulomatous Mastitis studies →First Affiliated Hospital of Zhejiang University is the lead sponsor of 263 studies on the registry; 144 are open to participants now.
Counted across the registry records on this site, refreshed daily.
[Inclusion Criteria]
Patients who are willing to participate in clinical research; females; age 18-70 years; >80%, \<2; non-lactating mastitis; core needle 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; (mainly low echo lesions detectable by breast ultrasound).
[Exclusion Criteria]
Related to subjects:
Pregnant, breast-feeding, or women planning to have children within 3 years; 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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Baricitinib，2mg QD，oral use.
Drug: Baricitinib
Baricitinib administered orally
Also known as: Olumiant, Baricinix
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.
Time frame: Until progression or recurrence, assessed up to approximately 24 months post-intervention
12-month recurrence rate
Relapse rate of IGM within 12 months after discontinuation of baricitinib when achiving CR, decreasing of 12 inflammation markers involving IL1β/IL2/IL4/IL6/IL8/IL10/IL17α/IL12P70/IFNα/IFNγ/TNFα.
Time frame: Until progression, assessed up to approximately 24 months post-intervention
Toxicity and side effects
Occurrence of adverse events (AEs) after baricitinib administered orally according to NCI CTCAE v5.0.
Time frame: Up to follow-up period, approximately 24 months post-intervention
This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Baricitinib
First Affiliated Hospital of Zhejiang University →