Overview
Granulomatous mastitis (GM), also known as idiopathic granulomatous mastitis (IGM), is a rare, benign, chronic inflammatory condition of the breast. It is characterized by the formation of non-caseating granulomas within the breast lobules, in the absence of identifiable infectious, autoimmune, or foreign body causes. The condition predominantly affects women of childbearing age, typically within a few years of pregnancy and breastfeeding, though it can occur in nulliparous women and, very rarely, in men. The disease primarily affects the breast tissue and may present as a firm, painful breast mass that can mimic breast carcinoma on clinical examination and imaging. Key symptoms include a unilateral breast lump, pain, skin erythema, abscess formation, draining sinus tracts, nipple retraction, and fistulae. Axillary lymphadenopathy may also be present. The condition can follow a relapsing and remitting course, causing significant morbidity and distress. Diagnosis is made by exclusion after histopathological examination of a biopsy specimen reveals characteristic granulomatous inflammation, and other causes such as tuberculosis, sarcoidosis, and fungal infections have been ruled out. The treatment landscape for granulomatous mastitis remains challenging and somewhat controversial due to the lack of large randomized controlled trials. Management options include observation (as some cases resolve spontaneously), corticosteroids (the most commonly used first-line medical therapy), immunosuppressive agents such as methotrexate (often used as steroid-sparing agents or for refractory cases), and surgical excision. Antibiotics are used when secondary bacterial infection is present. Recurrence rates can be significant regardless of the treatment approach chosen. A multidisciplinary approach involving breast surgeons, pathologists, and sometimes rheumatologists is often recommended for optimal management.
Also known as:
Adult
Begins in adulthood (age 18 or older)
FDA & Trial Timeline
10 eventsAzienda Ospedaliera di Padova — PHASE2
European Breast Cancer Research Association of Surgical Trialists
All India Institute of Medical Sciences, Bhubaneswar — PHASE1, PHASE2
Institut Pasteur de Dakar
National University Hospital, Singapore — PHASE4
Assiut University — PHASE1
Mayo Clinic
Hubei Cancer Hospital — NA
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Data sourced from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.
Treatments
No FDA-approved treatments are currently listed for Granulomatous mastitis.
5 clinical trialsare actively recruiting — trials can provide access to cutting-edge therapies.
View clinical trials →Treatment Centers
8 centersBaylor College of Medicine Rare Disease Center ↗
Baylor College of Medicine
📍 Houston, TX
🏥 NORDStanford Medicine Rare Disease Center ↗
Stanford Medicine
📍 Stanford, CA
🔬 UDNNIH Clinical Center Undiagnosed Diseases Program ↗
National Institutes of Health
📍 Bethesda, MD
🔬 UDNUCLA UDN Clinical Site ↗
UCLA Health
📍 Los Angeles, CA
🔬 UDNBaylor College of Medicine UDN Clinical Site ↗
Baylor College of Medicine
📍 Houston, TX
🔬 UDNHarvard/MGH UDN Clinical Site ↗
Massachusetts General Hospital
📍 Boston, MA
🏥 NORDMayo Clinic Center for Individualized Medicine ↗
Mayo Clinic
📍 Rochester, MN
👤 Mayo Clinic Center for Individualized Medicine
🏥 NORDUCLA Rare Disease Day Program ↗
UCLA Health
📍 Los Angeles, CA
Travel Grants
No travel grants are currently matched to Granulomatous mastitis.
Community
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Start the conversation →Latest news about Granulomatous mastitis
Disease timeline:
New recruiting trial: Access HBV Assays - European Union (EU) Clinical Trial Protocol -
A new clinical trial is recruiting patients for Granulomatous mastitis
New recruiting trial: A Cross-sectional Study on the Positive Rate of M Protein Based on a Highly Sensitive Serum M Protein Detection Method.
A new clinical trial is recruiting patients for Granulomatous mastitis
New recruiting trial: Efficacy of Venetoclax in Combination With Rituximab in Waldenström's Macroglobulinemia
A new clinical trial is recruiting patients for Granulomatous mastitis
New recruiting trial: Immunoglobulin M (IgM)-Anti-myelin-associated-glycoprotein(MAG) Peripheral Neuropathy Study
A new clinical trial is recruiting patients for Granulomatous mastitis
New recruiting trial: A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma
A new clinical trial is recruiting patients for Granulomatous mastitis
New recruiting trial: Zanubrutinib Treatment in Patients With IgM Monoclonal Gammopathy and Antri-MAG Related Polyneuropathy
A new clinical trial is recruiting patients for Granulomatous mastitis
New recruiting trial: Effect of Different Surgical Approaches of Granulomatous Mastitis
A new clinical trial is recruiting patients for Granulomatous mastitis
New recruiting trial: Surgical Intervention for Refractory Granulomatous Lobular Mastitis
A new clinical trial is recruiting patients for Granulomatous mastitis
New recruiting trial: Analysis of Various Treatment Methods of Granulomatous Lobular Mastitis
A new clinical trial is recruiting patients for Granulomatous mastitis
Caregiver Resources
NORD Caregiver Resources
Support, advocacy, and financial assistance for caregivers of rare disease patients.
Mental Health Support
Rare disease caregiving can be isolating. Connect with counseling and peer support.
Family & Caregiver Grants
Financial assistance programs specifically for caregivers of rare disease patients.
Social Security Disability
Learn how rare disease patients may qualify for SSDI/SSI benefits.
Common questions about Granulomatous mastitis
What is Granulomatous mastitis?
Granulomatous mastitis (GM), also known as idiopathic granulomatous mastitis (IGM), is a rare, benign, chronic inflammatory condition of the breast. It is characterized by the formation of non-caseating granulomas within the breast lobules, in the absence of identifiable infectious, autoimmune, or foreign body causes. The condition predominantly affects women of childbearing age, typically within a few years of pregnancy and breastfeeding, though it can occur in nulliparous women and, very rarely, in men. The disease primarily affects the breast tissue and may present as a firm, painful breas
At what age does Granulomatous mastitis typically begin?
Typical onset of Granulomatous mastitis is adult. Age of onset can vary across affected individuals.
Are there clinical trials for Granulomatous mastitis?
Yes — 5 recruiting clinical trials are currently listed for Granulomatous mastitis on UniteRare. See the clinical trials section on this page for phase, sponsor, and site details sourced from ClinicalTrials.gov.
Which specialists treat Granulomatous mastitis?
10 specialists and care centers treating Granulomatous mastitis are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.