Comparing Effectiveness of Steroids and Methotrexate in Treatment of Chronic Inflammatory Breast Disease

NCT06943482 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2023/00773
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Granulomatous Mastitis

Keywords

Breast; Breast Conditions; Mastits; Granulomatous Mastitis; Inflammation; Breast Surgery; Rhematologist

Outcome Measures

Primary Outcomes (3)

• Proportion of patients who achieved clinical or radiological complete response by 6 months

  6 months

• Time to clinical response and time to radiological response

  6 months

• Proportion of patients with relapse in a year within affected breast between each arm.

  1 year

Secondary Outcomes (7)

• Evaluation of side effects.

  1 year

• Evaluation of of treatment failure (TF) rate

  6 months

• Evaluation of frequency of percutaneous or surgical intervention required

  6 months

• Evaluation of potential unique pattern of gene expression that can be used to diagnose IGM and predict treatment response

  3 years

• Evaluation of potential biomarkers that may predict response to treatment: eg IL-6, CRP and neutrophil to lymphocyte ratio (NLR)

  3 years

Study Arms (2)

Steroid

ACTIVE COMPARATOR

Drug: Prednisolone; Drug: Omeprazole 20 mg

Methotrexate

EXPERIMENTAL

Drug: Methotrexate; Drug: Folic Acid 5 MG

Interventions

Prednisolone DRUG

20mg of prednisolone will be prescribed, taken orally, and daily for first month followed by tapering doses of 15mg over one month, then 12.5mg for one month, proceeding to 10mg for one month, subsequently taking 7.5mg for one month, and lastly 5mg for one month.

Steroid

Methotrexate DRUG

10mg of methotrexate will be prescribed to be taken once a week for one month. The dosage will be increased to 15mg of methotrexate taken once a week on the 1st (T1) month clinical visit and will be further increased to 20mg of methotrexate taken once a week on the 2nd (T2) month clinical visit. There will be no further escalation of dosage after this visit.

Methotrexate

Folic Acid 5 MG DRUG

5mg of folic acid is to be taken together with methotrexate once a week.

Methotrexate

Omeprazole 20 mg DRUG

Omeprazole will be prescribed at 20mg to protect the stomach lining.

Steroid

Eligibility Criteria

• Age: 21 Years - 60 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

Related Publications (10)

• 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.

  PMID: 25516860 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 31968055 BACKGROUND

• 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.

  PMID: 36865415 BACKGROUND

• 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.

  PMID: 22872797 BACKGROUND

• 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.

  PMID: 34602947 BACKGROUND

• 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.

  PMID: 12662235 BACKGROUND

• 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.

  PMID: 31203215 BACKGROUND

• 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.

  PMID: 25751209 BACKGROUND

MeSH Terms

Conditions

Granulomatous Mastitis; Inflammation

Interventions

Prednisolone; Methotrexate; Folic Acid; Omeprazole

Condition Hierarchy (Ancestors)

Mastitis; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles

Study Officials

• Serene Si Ning Goh, MBBS

  National

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Serene Si Ning Goh, MBBS

CONTACT

+65 9100 6954; serene_sn_goh@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 24, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 24, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)