Clinical trial NCT06943482: Comparing Effectiveness of Steroids and Methotrexate in Treatment of Chronic Inflammatory Breast Disease
Official title: A Pilot Open-label Randomised Trial Comparing the Effectiveness of Steroids and Methotrexate for the Treatment of Idiopathic Granulomatous Mastitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Idiopathic Granulomatous Mastitis
Keywords: Breast
Breast Conditions
Mastits
Granulomatous Mastitis
Inflammation
Breast Surgery
Rhematologist
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study is to determine the effectiveness of prednisolone and methotrexate for IGM patients over a period of one year, in terms of clinical and radiological response. Recruitment will be conducted in National University Hospital (NUH) for patients diagnosed with IGM.


Eligibility criteria: Inclusion Criteria:

* Women, aged between 21 and 60 years
* Positive diagnosis of idiopathic granulomatous mastitis based on histopathology results
* Willing and able to give informed consent

Exclusion Criteria (Patients who meet any of the following prerequisites will not be allowed to take part in this study):

* Women who are currently pregnant or breastfeeding
* Cognitive impairment which prevents the patient from giving voluntary consent
* History of any psychiatric conditions such as depression, psychosis, schizophrenia etc.
* History of cancer in the past 5 years
* History of abnormal renal or liver function
* History of diabetes mellitus
* History of pulmonary lung disease, pneumonitis, or related conditions
* Hepatitis B and/or Hepatitis C carrier
* Diagnosed with tuberculosis (Positive microbiological evaluation for Grocott Methenamine Silver stain and Ziehl- Neelsen stain)
* Any immunosuppressants or anti-inflammatory medications such as NSAIDS for the past 3 months
* Concomitant medication that may have contraindication with prednisolone and methotrexate use
* Hypersensitivity to components or drug products of prednisolone and methotrexate
* Vaccination with live virus vaccines prior to or during treatment

Primary outcomes:
measure: Proportion of patients who achieved clinical or radiological complete response by 6 months
timeFrame: 6 months
measure: Time to clinical response and time to radiological response
timeFrame: 6 months
measure: Proportion of patients with relapse in a year within affected breast between each arm.
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of side effects.
timeFrame: 1 year
measure: Evaluation of of treatment failure (TF) rate
timeFrame: 6 months
measure: Evaluation of frequency of percutaneous or surgical intervention required
timeFrame: 6 months
measure: Evaluation of potential unique pattern of gene expression that can be used to diagnose IGM and predict treatment response
timeFrame: 3 years
measure: Evaluation of potential biomarkers that may predict response to treatment: eg IL-6, CRP and neutrophil to lymphocyte ratio (NLR)
timeFrame: 3 years
measure: Evaluation of patient reported outcome measures
timeFrame: 3 years
measure: Validate survey instrument for IGM patients
timeFrame: 3 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National
name: Serene Si Ning Goh, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Altintoprak F, Kivilcim T, Ozkan OV. Aetiology of idiopathic granulomatous mastitis. World J Clin Cases. 2014 Dec 16;2(12):852-8. doi: 10.12998/wjcc.v2.i12.852.
citation: Manogna, P., Dev, B., Joseph, L.D. et al. Idiopathic granulomatous mastitis-our experience. Egypt J Radiol Nucl Med 51, 15 (2020). https://doi.org/10.1186/s43055-019-0126-4
citation: Kehribar, D. Y., Duran, T. I., Cetinkaya, G. K., Polat, A. K., Ozgen, M. (2020). Evaluation of Symptoms, Depression and Anxiety Levels in Young Women with Idiopathic Granulomatous Mastitis. Int J Acad Med Pharm, 2(2), 57-61. https://doi.org/10.29228/jamp.42734
citation: Steuer AB, Stern MJ, Cobos G, Castilla C, Joseph KA, Pomeranz MK, Femia AN. Clinical Characteristics and Medical Management of Idiopathic Granulomatous Mastitis. JAMA Dermatol. 2020 Apr 1;156(4):460-464. doi: 10.1001/jamadermatol.2019.4516.
citation: Al Awfi MM, Al Rahbi SK. Idiopathic Granulomatous Mastitis: Six years of experience and the current evidence in literature. Sultan Qaboos Univ Med J. 2023 Feb;23(1):36-41. doi: 10.18295/squmj.4.2022.030. Epub 2023 Feb 23.
citation: Kayahan M, Kadioglu H, Muslumanoglu M. Management of Patients with Granulomatous Mastitis: Analysis of 31 Cases. Breast Care (Basel). 2012 Jun;7(3):226-230. doi: 10.1159/000337758. Epub 2012 Jun 27.
citation: Kafadar MT, Bahadir MV, Girgin S. Low-Dose Methotrexate Use in Idiopathic Granulomatous Mastitis: An Alternative Treatment Method. Breast Care (Basel). 2021 Aug;16(4):402-407. doi: 10.1159/000513879. Epub 2021 Jan 22.
citation: Kim J, Tymms KE, Buckingham JM. Methotrexate in the management of granulomatous mastitis. ANZ J Surg. 2003 Apr;73(4):247-9. doi: 10.1046/j.1445-1433.2002.02564.x.
citation: Postolova A, Troxell ML, Wapnir IL, Genovese MC. Methotrexate in the Treatment of Idiopathic Granulomatous Mastitis. J Rheumatol. 2020 Jun 1;47(6):924-927. doi: 10.3899/jrheum.181205. Epub 2019 Jun 15.
citation: Sheybani F, Sarvghad M, Naderi H, Gharib M. Treatment for and clinical characteristics of granulomatous mastitis. Obstet Gynecol. 2015 Apr;125(4):801-807. doi: 10.1097/AOG.0000000000000734.