Granulomatous mastitis

Last reviewed

🖨 Print for my doctorAdvocacy Hub →
ORPHA:64722N61
Who is this for?
Show terms as
5Active trials10Specialists8Treatment centers

Where are you in your journey?

UniteRare data is sourced from FDA.gov, ClinicalTrials.gov, Orphanet, OMIM, and NORD.
Report missing data

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:

Age of Onset

Adult

Begins in adulthood (age 18 or older)

Orphanet ↗NORD ↗

FDA & Trial Timeline

10 events
May 2026Zanubritnib and Anti-MAG Neuropathy

Azienda Ospedaliera di Padova — PHASE2

TrialNOT YET RECRUITING
Apr 2026GRAnulomatous MAstitis REGistry Study

European Breast Cancer Research Association of Surgical Trialists

TrialNOT YET RECRUITING
Mar 2026Antibiotics vs Corticosteroids in Treatment of Granulomatous Lobular Mastitis

All India Institute of Medical Sciences, Bhubaneswar — PHASE1, PHASE2

TrialNOT YET RECRUITING
Jul 2025Clinical Diagnostic Performance Evaluation of a Measles Rapid Test in Senegal

Institut Pasteur de Dakar

TrialNOT YET RECRUITING
Jul 2025Comparing Effectiveness of Steroids and Methotrexate in Treatment of Chronic Inflammatory Breast Disease

National University Hospital, Singapore — PHASE4

TrialNOT YET RECRUITING
Jun 2025Steroid Injection in Idiopathic Granulomatous Mastitis

Assiut University — PHASE1

TrialNOT YET RECRUITING
Feb 2025A Study of Carbon 13-based Deep Labelling of Bone Marrow Cells

Mayo Clinic

TrialENROLLING BY INVITATION
Nov 2024Effect of Different Surgical Approaches of Granulomatous Mastitis

Hubei Cancer Hospital — NA

TrialRECRUITING
Sep 2024Observation Alone for Mild Non-Lactational Mastitis

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

TrialRECRUITING
Aug 2024Validity and Reliability of the Mastitis Symptom Severity Assessment Methods (M-Score and BISSI) in Non-Lactational Mastitis

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

TrialRECRUITING

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 →

Clinical Trials

5 recruitingView all trials with filters →
Phase 21 trial
Baricitinib in Idiopathic Granulomatous Mastitis
Phase 2
Active
PI: Haiyan Wei, Doctor (Zhejiang University) · Sites: Hangzhou, Zhejiang · Age: 1870 yrs
N/A1 trial
Effect of Different Surgical Approaches of Granulomatous Mastitis
N/A
Actively Recruiting
PI: Xinhong Wu, Doctor (Hubei Cancer Hospital) · Sites: Wuhan, Hubei · Age: 1899 yrs
Other3 trials
Analysis of Various Treatment Methods of Granulomatous Lobular Mastitis
Actively Recruiting
PI: Jing Feng (First Affiliated Hospital of Harbin Medical Univer) · Sites: Harbin, Heilongjiang · Age: 1565 yrs
Validity and Reliability of the Mastitis Symptom Severity Assessment Methods (M-Score and BISSI) in Non-Lactational Mastitis
Actively Recruiting
· Sites: Chaozhou, Guangdong; Dongguan, Guangdong +3 more · Age: 1865 yrs
Observation Alone for Mild Non-Lactational Mastitis
Actively Recruiting
· Sites: Guangzhou, Guangdong; Shanwei, Guangdong · Age: 1865 yrs

Specialists

10 foundView all specialists →
JF
Jing Feng
Specialist
PI on 2 active trials151 Granulomatous mastitis publications
AP
Atilla Soran, Professor
PITTSBURGH, PA
Specialist
PI on 1 active trial1 Granulomatous mastitis publication
HD
Haiyan Wei, Doctor
Specialist
PI on 1 active trial
EM
Erwei Song, MD
Specialist
PI on 1 active trial
UA
Ufuk Oguz Idiz, Assoc.Prof.
Specialist
PI on 2 active trials
EM
Erwei Song, M.D.
Specialist
PI on 1 active trial
SM
Shunrong Li, M.D.
Specialist
PI on 1 active trial
TM
Tushar Subhadarshan Mishra
BIRMINGHAM, AL
Specialist
PI on 1 active trial
OA
Ozgur Aytac
Specialist
PI on 1 active trial
XW
Xinhong Wu
Specialist
PI on 1 active trial

Treatment Centers

8 centers
🏥 NORD

Baylor College of Medicine Rare Disease Center

Baylor College of Medicine

📍 Houston, TX

🏥 NORD

Stanford Medicine Rare Disease Center

Stanford Medicine

📍 Stanford, CA

🔬 UDN

NIH Clinical Center Undiagnosed Diseases Program

National Institutes of Health

📍 Bethesda, MD

🔬 UDN

UCLA UDN Clinical Site

UCLA Health

📍 Los Angeles, CA

🔬 UDN

Baylor College of Medicine UDN Clinical Site

Baylor College of Medicine

📍 Houston, TX

🔬 UDN

Harvard/MGH UDN Clinical Site

Massachusetts General Hospital

📍 Boston, MA

🏥 NORD

Mayo Clinic Center for Individualized Medicine

Mayo Clinic

📍 Rochester, MN

👤 Mayo Clinic Center for Individualized Medicine

🏥 NORD

UCLA Rare Disease Day Program

UCLA Health

📍 Los Angeles, CA

Travel Grants

No travel grants are currently matched to Granulomatous mastitis.

Search all travel grants →NORD Financial Assistance ↗

Community

Open Granulomatous mastitisForum →

No community posts yet. Be the first to share your experience with Granulomatous mastitis.

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.