Granulomatous Lobular MastitisPhase 1/2NCT07595900
Tocilizumab for the Treatment of Refractory Granulomatous Lobular Mastitis
A Phase 1/2 study testing Tocilizumab in people with Granulomatous Lobular Mastitis and Granulomatous Mastitis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
Non-Lactational Granulomatous Lobular Mastitis (NL-GLM) is an inflammatory disease of unknown etiology, characterized clinically by local breast masses, accompanied by redness and swelling of the overlying skin, sinus tract formation, and other symptoms. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Granulomatous Lobular Mastitis, Granulomatous Mastitis
- What is being tested?
- Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 30 Oct 2028
- Phase
- Phase 1/2
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females aged 20 to 50 years;
- Clinically diagnosed (combined with pathology) with non-lactational granulomatous mastitis (cessation of lactation for more than 6 months);
- M-Activity-Score ≥ 2;
- Steroid-refractory NL-GLM or intolerant to steroid therapy.
- Female subjects of childbearing potential agree to use highly effective contraception starting at least 7 days before the first dose until 16 weeks after dosing. Pregnancy tests for female subjects of childbearing potential must be negative within 7 days before the first dose.
Who cannot join
- Bilateral mastitis occurring simultaneously or sequentially within six months.
- Clinical diagnosis (combined with pathological findings) of periductal mastitis.
- History of lymphoproliferative disorder; or presence of signs or symptoms suggestive of a possible lymphoproliferative disorder (including lymphadenopathy or splenomegaly); or active primary or recurrent malignancy; or clinically significant malignancy with a remission duration of less than 5 years.
- Patients with carcinoma in situ of the cervix may participate if successfully treated with no evidence of recurrence or metastasis for at least 3 years.
- Patients with basal cell or squamous cell carcinoma of the skin may participate if successfully treated with no evidence of recurrence for at least 3 years.
- Patients who are pregnant.
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- Current or recent severe viral, bacterial, fungal, or parasitic infection, including but not limited to:
- Symptomatic herpes zoster infection within 12 weeks prior to screening.
- History of disseminated/complicated herpes zoster (e.g., multidermatomal involvement, herpes zoster ophthalmicus, CNS involvement, or postherpetic neuralgia).
- Symptomatic herpes simplex at the time of enrollment.
- Active or chronic infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- Household contact with an individual with active tuberculosis (TB) and not having received appropriate and documented TB prophylaxis.
- Evidence of active TB, or history of active TB without appropriate and documented treatment.
- Clinically significant infection within 4 weeks prior to enrollment, or having received intravenous antibiotic therapy for an infection.
- Any other active or recent infection within 4 weeks prior to enrollment that, in the investigator's judgment, would pose an unacceptable risk to the patient.
- Note: Recent viral upper respiratory tract infections or uncomplicated urinary tract infections should not be considered clinically significant.
- Patients with hepatic or renal insufficiency, gastrointestinal ulcer, active hepatitis, active rheumatic autoimmune disease, active tuberculosis, or poorly controlled psychiatric disorders.
- Cardiac, pulmonary, hepatic, renal, or coagulation dysfunction that, in the investigator's judgment, makes the patient unsuitable for enrollment.
- History of hypersensitivity to tocilizumab.
- Previous treatment with tocilizumab (a single prior dose may be exempted upon investigator's assessment).
- Any major surgery within 8 weeks prior to screening, or requirement for major surgery during the study period, which, in the investigator's judgment, would pose an unacceptable risk to the patient.
- Presence of the following laboratory abnormalities, or any other laboratory value outside the reference range deemed by the investigator to pose an unacceptable risk for participation:
- AST or ALT ≥ 2 × upper limit of normal (ULN)
- Alkaline phosphatase (ALP) ≥ 2 × ULN
- Total bilirubin (TBL) ≥ 1.5 × ULN
- Hemoglobin < 9.0 g/dL
- Total white blood cell count < 2.5 × 10⁹ cells/L
- Neutropenia (absolute neutrophil count [ANC] < 1.2 × 10⁹ cells/L)
- Lymphopenia (lymphocyte count < 0.75 × 10⁹ cells/L)
- Thrombocytopenia (platelets < 100 × 10⁹/L)
- Estimated glomerular filtration rate (eGFR) < 40 mL/min/1.73 m² (based on the CKD-EPI equation) Note: The above abnormalities may be retested during the screening period, with eligibility determined based on the retest results.
- Administration of a live or attenuated vaccine within 6 weeks prior to the first dose, or planned administration during the treatment period or within 6 weeks after the last dose.
- Body weight ≥ 100 kg.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Tocilizumab in the Treatment of Refractory Granulomatous Lobular Mastitis: A Two-Center, Single-Arm Clinical Trial
Non-Lactational Granulomatous Lobular Mastitis (NL-GLM) is an inflammatory disease of unknown etiology, characterized clinically by local breast masses, accompanied by redness and swelling of the overlying skin, sinus tract formation, and other symptoms. Currently, there is no universally accepted standard treatment for this condition; previous expert consensus or practice guidelines have mostly recommended systemic glucocorticoid therapy as the primary treatment approach. Our team's preliminary research has confirmed that local glucocorticoid injection achieves efficacy equivalent to systemic administration but with better safety, making it a first-line treatment option for NL-GLM. However, in our preliminary studies and literature reports, we found that some patients still exhibit glucocorticoid dependence or resistance (i.e., refractory NL-GLM) after receiving either local or systemic glucocorticoid therapy. The lack of high-quality evidence to support subsequent-line treatments has become a major bottleneck in clinical management. Additionally, some patients cannot tolerate glucocorticoid therapy due to its adverse effects. Research has shown that the IL-6 inflammatory pathway is significantly activated in the lesion tissues and peripheral blood of NL-GLM patients, and the IL-6 inhibitor tocilizumab has demonstrated efficacy in various autoimmune diseases. Based on this, this study intends to conduct a dual-center, single-arm clinical trial to systematically evaluate the efficacy and safety of tocilizumab in the treatment of refractory NL-GLM. The aim is to fill the treatment gap, provide high-level evidence for clinical practice, and ultimately improve patient outcomes.
- Being tested
- Tocilizumab
- Medical subject headings
- Granulomatous Mastitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Enrolled patients received intravenous administration of tocilizumab at a dose of 8 mg/kg (maximum 400 mg) at Week 1 and Week 5 after enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab Treatment Group | Experimental | Not described Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
8-week inflammatory remission rate
Measured: Week 8 after enrollment
Secondary outcomes (1)
4/12/16-week inflammatory remission rate
Measured: Week 4/12/16 after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Granulomatous Lobular MastitisStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595900
- Sponsor's protocol ID
- SYSKY-2026-253-02
- Status last verified
- Jan 2026
- First submitted
- 13 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tocilizumab in the Treatment of Refractory Granulomatous Lobular Mastitis: A Two-Center, Single-Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT07595900
- Acronym / sponsor ID
- SYSKY-2026-253-02
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-Lactational Granulomatous Lobular Mastitis (NL-GLM) is an inflammatory disease of unknown etiology, characterized clinically by local breast masses, accompanied by redness and swelling of the overlying skin, sinus tract formation, and other symptoms. Currently, there is no universally accepted standard treatment for this condition; previous expert consensus or practice guidelines have mostly recommended systemic glucocorticoid therapy as the primary treatment approach. Our team's preliminary research has confirmed that local glucocorticoid injection achieves efficacy equivalent to systemic administration but with better safety, making it a first-line treatment option for NL-GLM. However, in our preliminary studies and literature reports, we found that some patients still exhibit glucocorticoid dependence or resistance (i.e., refractory NL-GLM) after receiving either local or systemic glucocorticoid therapy. The lack of high-quality evidence to support subsequent-line treatments has become a major bottleneck in clinical management. Additionally, some patients cannot tolerate glucocorticoid therapy due to its adverse effects. Research has shown that the IL-6 inflammatory pathway is significantly activated in the lesion tissues and peripheral blood of NL-GLM patients, and the IL-6 inhibitor tocilizumab has demonstrated efficacy in various autoimmune diseases. Based on this, this study intends to conduct a dual-center, single-arm clinical trial to systematically evaluate the efficacy and safety of tocilizumab in the treatment of refractory NL-GLM. The aim is to fill the treatment gap, provide high-level evidence for clinical practice, and ultimately improve patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab Treatment Group | Experimental | Drug: Tocilizumab |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Females aged 20 to 50 years;
- Clinically diagnosed (combined with pathology) with non-lactational granulomatous mastitis (cessation of lactation for more than 6 months);
- M-Activity-Score ≥ 2;
- Steroid-refractory NL-GLM or intolerant to steroid therapy.
- Female subjects of childbearing potential agree to use highly effective contraception starting at least 7 days before the first dose until 16 weeks after dosing. Pregnancy tests for female subjects of childbearing potential must be negative within 7 days before the first dose.
Key exclusion criteria (33 listed)
- Bilateral mastitis occurring simultaneously or sequentially within six months.
- Clinical diagnosis (combined with pathological findings) of periductal mastitis.
- History of lymphoproliferative disorder; or presence of signs or symptoms suggestive of a possible lymphoproliferative disorder (including lymphadenopathy or splenomegaly); or active primary or recurrent malignancy; or clinically significant malignancy with a remission duration of less than 5 years.
- Patients who are pregnant.
- Current or recent severe viral, bacterial, fungal, or parasitic infection, including but not limited to:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TocilizumabEnrolled patients received intravenous administration of tocilizumab at a dose of 8 mg/kg (maximum 400 mg) at Week 1 and Week 5 after enrollment. | Drug | Tocilizumab Treatment Group |
Primary outcome
8-week inflammatory remission rate
Time frame: Week 8 after enrollment
1 secondary outcome
4/12/16-week inflammatory remission rate
Time frame: Week 4/12/16 after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tocilizumab in people with Granulomatous Lobular Mastitis and Granulomatous Mastitis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 5 inclusion and 33 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 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Kai Chen (86-02034070166, ckaichen@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
8-week inflammatory remission rate (time frame: Week 8 after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.