Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06943482

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

21 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Folic Acid 5 MG

Drug

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

Omeprazole 20 mg

Drug

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

Primary outcomes

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

    Time frame: 6 months

  2. Time to clinical response and time to radiological response

    Time frame: 6 months

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

    Time frame: 1 year

Secondary outcomes

  1. Evaluation of side effects.

    Time frame: 1 year

  2. Evaluation of of treatment failure (TF) rate

    Time frame: 6 months

  3. Evaluation of frequency of percutaneous or surgical intervention required

    Time frame: 6 months

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

    Time frame: 3 years

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

    Time frame: 3 years

    Depending on the biomarkers tested, there will be different unit of measurements. Some examples of biomarkers that may be tested are:

    CRP: mg/l IL-6: pg/ml NLR: ratio

  6. Evaluation of patient reported outcome measures

    Time frame: 3 years

    Most of our questions are on a scale from 1 - 5, with some yes or no question and an open question at the end.

  7. Validate survey instrument for IGM patients

    Time frame: 3 years

    The survey is adopted from SF-36 for general health and EORTC BR23 for body image, breast health and pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Serene Si Ning Goh, MBBS

CONTACT

[email protected]

+65 9100 6954

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Registry information

Official study title

A Pilot Open-label Randomised Trial Comparing the Effectiveness of Steroids and Methotrexate for the Treatment of Idiopathic Granulomatous Mastitis

Acronym: IGM

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 24, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.