Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.
Department of Mammary Surgery, Lianjiang People's Hospital, Zhanjiang, Guangdong, China.
BMJ Open. 2020 Oct 10;10(10):e036643. doi: 10.1136/bmjopen-2019-036643.
The ideal treatment for idiopathic granulomatous mastitis (IGM) remains unclear. In a prospective, single-centre, pilot study, we reported that ductal lavage treatment for non-lactational mastitis patients had a 1-year clinical complete response (cCR) rate of >90%, without any significant adverse events. Thus, in this multicentre, randomised, open-label, non-inferiority trial, we will aim to compare the effectiveness and safety of ductal lavage vs oral corticosteroids as the first-line treatment for patients with IGM.
The trial will be conducted at the Breast Tumor Center of Sun Yat-sen Memorial Hospital in China and at least at one participating regional centre. We plan to recruit 140 eligible IGM patients who will be randomised into the ductal lavage group or oral corticosteroid group with a 1:1 ratio. The patients in the oral corticosteroid group will receive meprednisone or prednisone for 6 months. The patients in the ductal lavage group will receive ductal lavage and breast massage, as previously reported. All the participants will be followed up at the clinic for 1 year post randomisation. The primary endpoint of this trial will be the 1-year cCR rate, and the secondary endpoints will include the time to cCR, treatment failure rate, relapse rate and protocol compliance rate. The trial was designed to determine whether ductal lavage is non-inferior to oral corticosteroids (1-year cCR rate assumed to be 90%), with a non-inferiority margin of 15%.
The ethics committee of Sun Yat-sen Memorial Hospital at Sun Yat-sen University approved the study (2018-Lun-Shen-Yan-No. 30). The results of the trial will be communicated to the participating primary care practices, published in international journals and presented at international clinical and scientific conferences.
ClinicalTrials.gov Registry (NCT03724903); Pre-results.
特发性肉芽肿性乳腺炎（IGM）的理想治疗方法仍不清楚。在一项前瞻性、单中心、试点研究中，我们报道了非哺乳期乳腺炎患者的导管灌洗治疗在 1 年内的临床完全缓解（cCR）率>90%，且无明显不良事件。因此，在这项多中心、随机、开放标签、非劣效性试验中，我们将旨在比较导管灌洗与口服皮质类固醇作为 IGM 患者一线治疗的有效性和安全性。
该试验将在中国中山大学孙逸仙纪念医院的乳腺肿瘤中心和至少一个参与的区域中心进行。我们计划招募 140 名符合条件的 IGM 患者，将他们随机分为导管灌洗组或口服皮质类固醇组，比例为 1:1。口服皮质类固醇组患者将接受甲泼尼龙或泼尼松治疗 6 个月。导管灌洗组患者将接受导管灌洗和乳房按摩，如前所述。所有参与者将在随机分组后 1 年内进行门诊随访。该试验的主要终点是 1 年 cCR 率，次要终点包括 cCR 时间、治疗失败率、复发率和方案依从率。该试验旨在确定导管灌洗是否不劣于口服皮质类固醇（1 年 cCR 率假设为 90%），非劣效性边界为 15%。
中山大学孙逸仙纪念医院伦理委员会批准了该研究（2018-伦申言-30 号）。试验结果将传达给参与的初级保健实践，发表在国际期刊上，并在国际临床和科学会议上展示。
ClinicalTrials.gov 注册号（NCT03724903）；预结果。
