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Idiopathic Granulomatous MastitisPhase 4IGMNCT06943482

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

A Phase 4 study testing Prednisolone, Methotrexate and Folic Acid 5 MG in people with Idiopathic Granulomatous Mastitis, run by National University Hospital, Singapore at 1 site in Singapore.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 21 to 60 years, women only
Conditions the study is for
Idiopathic Granulomatous Mastitis
What is being tested?
Prednisolone, Methotrexate and Folic Acid 5 MG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSingapore
Study dates
1 Jul 2025to 1 Feb 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 17Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Serene Si Ning Goh, MBBS contact

+65 9100 6954

serene_sn_goh@nuhs.edu.sg

Singapore1 site

  • National University Hospital

    Singapore, 119074

    Serene Si Ning Goh, +65 9100 6954, serene_sn_goh@nuhs.edu.sg

Other trials in Singapore

About this study

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

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.

Being tested
Prednisolone, Methotrexate, Folic Acid 5 MG, Omeprazole 20 mg
Keywords
Breast, Breast Conditions, Mastits, Granulomatous Mastitis, Inflammation, Breast Surgery, Rhematologist
Medical subject headings
Granulomatous Mastitis, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrednisoloneDrug

    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.

  • MethotrexateDrug

    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 MGDrug

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

  • Omeprazole 20 mgDrug

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

Study groups in NCT06943482
Study groupRoleWhat they receive
SteroidActive comparatorNot described
Receives: Drug: Prednisolone; Drug: Omeprazole 20 mg
MethotrexateExperimentalNot described
Receives: Drug: Methotrexate; Drug: Folic Acid 5 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

  2. Time to clinical response and time to radiological response

    Measured: 6 months

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

    Measured: 1 year

Secondary outcomes (7)

  1. Evaluation of side effects.

    Measured: 1 year

  2. Evaluation of of treatment failure (TF) rate

    Measured: 6 months

  3. Evaluation of frequency of percutaneous or surgical intervention required

    Measured: 6 months

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

    Measured: 3 years

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

    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

    Measured: 3 years

  6. Evaluation of patient reported outcome measures

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

    Measured: 3 years

  7. Validate survey instrument for IGM patients

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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2025
  2. Study start1 Jul 2025 (estimated)
  3. Primary completion1 Feb 2028 (estimated)
  4. Study completion1 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06943482
Sponsor's protocol ID
2023/00773
Other IDs
2023
Acronym
IGM
Status last verified
Nov 2024
First submitted
17 Mar 2025
Last updated
24 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25516860

  • 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

  • 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

  • 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.

    PubMed 31968055

  • 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.

    PubMed 36865415

  • 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.

    PubMed 22872797

  • 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.

    PubMed 34602947

  • 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.

    PubMed 12662235

  • 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.

    PubMed 31203215

  • 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.

    PubMed 25751209

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Prednisolone, Methotrexate and Folic Acid 5 MG in people with Idiopathic Granulomatous Mastitis, run by National University Hospital, Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Serene Si Ning Goh, MBBS (+65 9100 6954, serene_sn_goh@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who achieved clinical or radiological complete response by 6 months (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06943482, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.

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