Medical and Surgical Treatment for Idiopathic Granulomatous Mastitis

Phase 4

• Conditions: Granulomatous Mastitis
• Interventions: Drug: Hydrocortisone Butyrate; Procedure: extended excision

• Registration Number: NCT02959580
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

This study evaluates the clinical response rate of topical steroids in the treatment of idiopathic granulomatous mastitis in female adults. Half of the participants will receive topical steroid and the other half will receive local wide surgical excision.

Detailed Description

Idiopathic granulomatous mastitis (IGM) is a rare benign inflammatory breast disease of unknown etiology.It may present with many findings that clinically and radiologically mimic breast cancer.

Although IGM as a disease has been known for nearly four decades, the optimal treatment approach has not been established. Surgical intervention in the form of wide surgical excision was the mainstay of treatment before 1980, and is still performed depending on local expertise and preference.

Currently,surgical treatment and systemic steroid treatment are frequently employed. With the consideration of side effects of longterm systemic (oral) steroid usage, topical steroid without systemic use were assessed and showed satisfactory curative effect. But the data concerning the use of topical steroid therapy are still very limited.

Study Timeline

• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-09
• Study Start: 2017-01-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-05
• Last Update Posted: 2018-12-06
• Primary Completion: 2020-09-01
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Idiopathic Granulomatous Mastitis

Exclusion Criteria

• Breast Carcinoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
medical	Hydrocortisone Butyrate	Hydrocortisone butyrate cream(0.1%) was applied to the breast by the patient twice a day on alternate days until the termination of treatment.
surgical	extended excision	lesion extended excision

Primary Outcome Measures

Name	Time	Method
clinical response rate	six months	The clinical response is categorized into ''completely healed,'' ''inadequately healed,'' ''stable,'' ''worsened,'' or ''relapsed'' if the lesions had once healed but symptoms returned.

Secondary Outcome Measures

Name	Time	Method
granulomatous mastitis recurrence	two years

Trial Locations

Locations (1)

Department of Breast Surgery,Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China