Observation Alone for Mild Non-Lactational Mastitis

Observation Alone for Mild Non-Lactational Mastitis: A Cohort Study.

The goal of this observational study is to investigate the disease progression rate and timing in patients with mild Non-Lactational Granulomatous Lobular / Periductal Mastitis (NL-GLM/PDM) during follow-up with observation alone strategy. The main questions it aims to answer are: What is the rate of disease progression in mild NL-GLM/PDM patients under observation, and what clinical and pathological factors are associated with this progression? Participants with diagnosis of mild NL-GLM/PDM will be monitored over a specified period, with data collected on their clinical outcomes and relevant factors influencing disease progression.

Study Overview

• Status: Completed
• Conditions: Granulomatous Mastitis; Mastitis Chronic
• Intervention / Treatment: Other: Observation

Detailed Description

Non-Lactational Granulomatous Lobular / Periductal Mastitis (NL-GLM/PDM) is an inflammatory breast disease of unclear etiology, primarily characterized by the presence of breast masses. A variety of treatment approaches, including intralesional injection, ductal lavage therapy, or corticosteroids had been proposed. Recently, an increasing number of studies have demonstrated that an observation and follow-up strategy for mild cases can yield comparable efficacy. An international consensus recommends that this observation strategy may serve as a first-line treatment approach for mild NL-GLM patients, with additional therapies implemented only upon disease progression.However, in clinical practice, we have observed that some patients with mild NL-GLM/PDM experience disease progression during the observation period, necessitating further treatment. The proportion of this population and the specifics of their disease progression remain unknown. Additionally, the clinical and pathological factors associated with disease progression during observation have not been previously studied. This research aims to conduct a single-center, single-arm, prospective cohort study to investigate the rate and timing of disease progression in mild NL-GLM/PDM during observation, as well as to explore the clinical and pathological factors related to progression. The findings will provide further guidance for subsequent research and clinical practice.

• Study Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    • Shanwei, Guangdong, China, 516600
      • Shenshan Medical Center, Sun Yat-sen Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with non-lactational mastitis (defined as more than 6 months since stopping breastfeeding) who meet the eligibility criteria at the Breast Tumor Center of Sun Yat-sen Memorial Hospital, Sun Yat-sen University.

Description

Inclusion Criteria:

1. Female, aged 18 to 65 years;
2. Clinically diagnosed with possible non-lactational (more than 6 months since stopping breastfeeding) granulomatous lobular mastitis or periductal mastitis.
3. Mscore ≤ 4 points;
4. Patients with ultrasound findings suggesting localized breast abscess formation must have undergone abscess drainage before enrollment;
5. After education, participants should have a strong willingness for observation and follow-up, and, after discussing with the primary physician, jointly decide to proceed with observation and follow-up;
6. Signed informed consent form.

Exclusion Criteria:

1. Patients with confirmed or suspected breast malignancy;
2. Patients with bilateral mastitis (including those with bilateral simultaneous onset and those with sequential onset of non-lactational granulomatous mastitis);
3. Pregnant patients who are currently in the gestation period;
4. Patients who have had non-lactational mastitis in the same breast within the past year and have undergone treatments such as surgery, oral corticosteroids (for more than 2 weeks), anti-tuberculosis treatment (for more than 2 weeks), or ductal lavage therapy.
5. Patients who received surgery, oral corticosteroids, or anti-tuberculosis treatment for the non-lactational mastitis of the ipsilateral breast within 2 weeks before enrollment.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observation; In this study, the definition of "observation" is that participants cannot receive the following treatments currently considered to have a clear efficacy for NL-GLM/PDM.

Other: Observation; In this study, the definition of "observation" is that participants cannot receive the following treatments currently considered to have a clear efficacy for NL-GLM/PDM, including surgical treatments (minimally invasive excision or open excision, incision and drainage), ultrasound-guided aspiration, oral corticosteroid therapy, antibiotic treatment, anti-tuberculosis therapy, or ductal lavage therapy. As symptomatic management for pain, the use of NSAIDs is permitted. Additionally, for patients with fistulas or skin lesions, routine wound care is also allowed. These two interventions are not considered as receiving treatment intervention in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12-weeks Progression Free Proportion	The proportion of patients who did not experience disease progression events within 12 weeks after enrollment.	12 weeks after enrollment
12-weeks Treatment Free Proportion	The proportion of patients who did not experience any predefined treatments within 12 weeks after enrollment.	12 weeks after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
4-weeks Progression Free Proportion	The proportion of patients who did not experience disease progression events within 4 weeks after enrollment.	4 weeks after enrollment
24-weeks Progression Free Proportion	The proportion of patients who did not experience disease progression events within 24 weeks after enrollment.	24 weeks after enrollment
4-weeks Treatment Free Proportion	The proportion of patients who did not experience predefined treatments within 4 weeks after enrollment.	4 weeks after enrollment
24-weeks Treatment Free Proportion	The proportion of patients who did not experience predefined treatments within 24 weeks after enrollment.	24 weeks after enrollment
Median time to progression among Progressors	The median time of the first occurrence of a progression event among patients who experience disease progression.	24 weeks after enrollment
Median time to treatment intervention among patients with active treatment	The median time of the first occurrence of a treatment intervention event among patients who experience treatment intervention.	24 weeks after enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between blood test indicators with clinical outcomes	Explore the correlation between baseline and week 4 inflammatory blood test indicators and their dynamic changes with disease progression and treatment intervention.	24 weeks after enrollment
Correlation between clinicopathological biomarkers with clinical outcomes	Explore the correlation between clinical indicators, pathological indicators, and ultrasound indicators at baseline with disease progression and treatment intervention.	24 weeks after enrollment

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Publications and helpful links

General Publications

• Yuan QQ, Xiao SY, Farouk O, Du YT, Sheybani F, Tan QT, Akbulut S, Cetin K, Alikhassi A, Yaghan RJ, Durur-Subasi I, Altintoprak F, Eom TI, Alper F, Hasbahceci M, Martinez-Ramos D, Oztekin PS, Kwong A, Pluguez-Turull CW, Brownson KE, Chandanwale S, Habibi M, Lan LY, Zhou R, Zeng XT, Bai J, Bai JW, Chen QR, Chen X, Zha XM, Dai WJ, Dai ZJ, Feng QY, Gao QJ, Gao RF, Han BS, Hou JX, Hou W, Liao HY, Luo H, Liu ZR, Lu JH, Luo B, Ma XP, Qian J, Qin JY, Wei W, Wei G, Xu LY, Xue HC, Yang HW, Yang WG, Zhang CJ, Zhang F, Zhang GX, Zhang SK, Zhang SQ, Zhang YQ, Zhang YP, Zhang SC, Zhao DW, Zheng XM, Zheng LW, Xu GR, Zhou WB, Wu GS. Management of granulomatous lobular mastitis: an international multidisciplinary consensus (2021 edition). Mil Med Res. 2022 Apr 26;9(1):20. doi: 10.1186/s40779-022-00380-5.

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2024
• Primary Completion (Actual): January 30, 2026
• Study Completion (Actual): April 24, 2026

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: October 29, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Granulomatous Mastitis, Observation, Treatment; Periductal mastitis
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Skin Diseases; Breast Diseases; Puerperal Disorders; Skin and Connective Tissue Diseases; Mastitis; Granulomatous Mastitis; Investigative Techniques; Methods; Observation
• Other Study ID Numbers: SYSKY-2024-708-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD could be shared if the studies were completed for two years, and approvals were obtained from the administrators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No