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首页> 外文期刊>Japanese journal of clinical oncology. >A randomized controlled trial comparing primary tumour resection plus systemic therapy with systemic therapy alone in metastatic breast cancer (PRIM-BC): Japan Clinical Oncology Group Study JCOG1017
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A randomized controlled trial comparing primary tumour resection plus systemic therapy with systemic therapy alone in metastatic breast cancer (PRIM-BC): Japan Clinical Oncology Group Study JCOG1017

机译：一项随机对照试验比较了转移性乳腺癌中原发肿瘤切除加全身治疗与单纯全身治疗的比较（PRIM-BC）：日本临床肿瘤学小组研究JCOG1017

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摘要

This trial is being conducted to confirm the superiority, in terms of overall survival, of primary tumour resection plus systemic therapy to systemic therapy alone in patients with Stage IV breast cancer who are not refractory to primary systemic therapy. The inclusion criteria for the study are as follows: untreated patients with histologically confirmed invasive breast cancer with one or more measurable metastatic lesions diagnosed by radiological examination. All patients receive primary systemic therapy according to the estrogen receptor and human epidermal growth factor receptor type-2 status of the primary breast cancer after the first registration. After 3 months, the patients without disease progression are randomized to the primary tumour resection plus systemic therapy arm or the systemic therapy alone arm. The primary endpoint is the overall survival, and the secondary endpoints are proportion of patients without tumour progression at the metastatic sites, yearly local recurrence-free survival, proportion of local ulcer/local bleeding, yearly primary tumour resection-free survival, adverse events of chemotherapy, operative morbidity and serious adverse events. The patient recruitment was commenced in May 2011. Enrolment of 410 patients for randomization is planned over a 5 year recruitment period. We hereby report the details of the study.
机译：进行该试验的目的是证实在IV期乳腺癌患者中，原发肿瘤切除加全身治疗优于单纯全身治疗在总体生存率方面不具优势，而该患者对主要全身治疗无效。该研究的纳入标准如下：未经治疗的组织学确诊为浸润性乳腺癌的患者，其通过放射学检查诊断为一种或多种可测量的转移性病变。首次注册后，所有患者均根据原发性乳腺癌的雌激素受体和人类表皮生长因子受体2型状态接受一次全身性治疗。 3个月后，无疾病进展的患者被随机分为原发肿瘤切除加全身治疗组或全身治疗组。主要终点为总体生存，次要终点为转移部位无肿瘤进展的患者比例，每年局部无复发生存率，局部溃疡/局部出血比例，每年一次无肿瘤切除生存率，不良反应化学疗法，手术发病率和严重不良事件。患者招募始于2011年5月。计划在5年的招募期间招募410名患者以进行随机分组。我们特此报告研究的细节。

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