Tocilizumab for the Treatment of Refractory Granulomatous Lobular Mastitis

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study ID
NCT07595900
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Granulomatous Lobular Mastitis
  • Granulomatous Mastitis

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    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 Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Jan 2026
Primary completion
Oct 30, 2028
Completion
Oct 30, 2028

Study Design

Enrollment
31 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab Treatment Group

Primary Outcome Measure

8-week inflammatory remission rate [ Time Frame: Week 8 after enrollment ]

Central Contacts