今天是:2019-03-25 星期一

马来酸吡咯替尼片联合标准治疗方案治疗HER2阳性乳腺癌脑转移患者的单臂、开放性临床研究
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注册号:

Registration number:

ChiCTR1900020670 

最近更新日期:

Date of Last Refreshed on:

2019-01-12 

注册时间:

Date of Registration:

2019-01-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

马来酸吡咯替尼片联合标准治疗方案治疗HER2阳性乳腺癌脑转移患者的单臂、开放性临床研究 

Public title:

Pyrrolidine combined with Standard treatment plan in patients with previously untreated brain metastases from HER2-positive metastatic breast cancer(LANDSCAPE): a single-arm, open-label clinical study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

马来酸吡咯替尼片联合标准治疗方案治疗HER2阳性乳腺癌脑转移患者的单臂、开放性临床研究 

Scientific title:

Pyrrolidine combined with Standard treatment plan in patients with previously untreated brain metastases from HER2-positive metastatic breast cancer(LANDSCAPE): a single-arm, open-label clinical study 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

赵曙 

研究负责人:

刘夕琳 

Applicant:

Shu Zhao 

Study leader:

Shu Zhao 

申请注册联系人电话:

Applicant telephone:

+86 13946158616 

研究负责人电话:

Study leader's telephone:

+86 13946158616 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

490989946@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

zs_1881@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

哈尔滨市南岗区哈平路150号 

研究负责人通讯地址:

哈尔滨市南岗区哈平路150号 

Applicant address:

150 Haping Road, Nangang District, Harbin, Heilongjiang, China  

Study leader's address:

150 Haping Road, Nangang District, Harbin, Heilongjiang, China  

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

哈尔滨医科大学附属肿瘤医院 

Applicant's institution:

Affiliated Cancer Hospital of Harbin Medical University  

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

哈尔滨医科大学附属肿瘤医院 

Primary sponsor:

Affiliated Cancer Hospital of Harbin Medical University  

研究实施负责(组长)单位地址:

黑龙江省哈尔滨市南岗区哈平路150号 

Primary sponsor's address:

150 Haping Road, Nangang District, Harbin, Heilongjiang, China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

黑龙江省

市(区县):

Country:

China

Province:

Heilongjiang

City:

单位(医院):

哈尔滨医科大学附属肿瘤医院

具体地址:

黑龙江省哈尔滨市南岗区哈平路150号

Institution
hospital:

Affiliated Cancer Hospital of Harbin Medical University

Address:

150 Haping Road, Nangang District, Harbin, Heilongjiang, China

经费或物资来源:

自筹 

Source(s) of funding:

By oneself 

研究疾病:

HER2表达阳性乳腺癌脑转移 

Target disease:

HER2-positive breast cancer with brain metastases 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

观察马来酸吡咯替尼片联合标准治疗方案治疗HER2表达阳性乳腺癌脑转移的安全性和有效性 

Objectives of Study:

To observe the safety and efficacy of pyrrolidine combined with standard treatment plan in the treatment of previously untreated brain metastases from HER2-positive metastatic breast cancer 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例研究 

Study design:

Case study 

纳入标准:

1. 受试者自愿加入本研究,签署知情同意书,依从性好,配合随访; 2. 年龄≥18岁的女性; 3. ECOG PS:0-2分; 4. 经免疫组化或荧光原位杂交确定为HER2阳性的乳腺癌; 5. 按RECIST 1.1版标准(见附录)至少具有一个大于10 mm颅内可测量病灶;可同时合并/不合并非颅内转移灶。 6. 预计生存期≥3月; 7. 主要器官的功能水平必须符合下列要求(筛选前2周内未输血,未使用过升白细胞、升血小板药物): a) 血常规: Hb≥90 g/L; ANC≥1.5×109 /L; PLT≥75×109 /L; b) 血生化: TBIL≤1.5×ULN; ALT和AST≤2×ULN;如有肝转移,则ALT和AST≤5×ULN; 尿素氮(BUN)和肌酐(Cr)≤1.5×ULN; c) 心脏彩超 左室射血分数(LVEF)≥50%; d) 12导联心电图 Fridericia法校正的QT间期(QTcF)< 470 msec。 8. 育龄妇女必须在入组前7天内进行妊娠试验(血清或尿液),且结果为阴性,并且愿意在试验期间和末次给予试验药物后8周采用适当的方法避孕; 

Inclusion criteria

1. Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure; 2. Women aged at least 18 years old; 3. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2; 4. HER2-positive breast cancer identified by immunohistochemistry or fluorescence in situ hybridization; 5. According to RECIST version 1.1 (see appendix), there is at least one intracranial measurable lesion larger than 10 mm; 6. Estimated survival (> 3 months); 7. The functional level of the main organs must meet the following requirements (no blood transfusion or drugs for raising white blood cells or platelets were used in the first 2 weeks of screening): 1) blood routine: neutrophils (ANC) greater than or equal to 1.5 x 10^9/L; Platelet count (PLT) greater than or equal to 90 x 10^9/L;Hemoglobin (Hb) is greater than or equal to 90 g/L; 2) blood biochemistry: total bilirubin (TBIL) is less than or equal to the upper limit of normal value (ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are less than or equal to 1.5 * ULN.Alkaline phosphatase is less than or equal to 2.5 times ULN;Urea nitrogen (BUN) and creatinine (Cr) less than or equal to 1.5 * ULN; 3) cardiac color doppler ultrasound: LVEF is greater than or equal to 55%; 4) 12-lead ecg: the QT interval (QTcF) < 470 msec corrected by Fridericia method; 8. Women of childbearing age must have reliable contraceptive measures or in the group of 7 days before the pregnancy test (serum or urine), and the results were negative, and willing to during the test and the last for 8 weeks after experimental drug using appropriate methods of contraception. 

排除标准:

1. 妊娠或哺乳期妇女; 2. 可接受手术的单个脑转移瘤患者; 3. 之前进行过马来酸吡咯替尼治疗; 4. 前2周内接受过化疗、靶向治疗或试验药物;前7天内接受过内分泌治疗; 5. 存在无法通过引流或其他方控制的第三间隙积液(如胸水和腹); 6. 无法吞咽、肠梗阻或存在影响药物服用和吸收的其他因素; 7. 过敏体质者,或已知对本方案药物组分有史者;免疫缺陷病包括HIV检测阳性,或患有其他获得、先天免疫缺陷疾病器官移植史 ; 8. 既往5年内患有其他恶性肿瘤,不包括已治愈的宫颈原位癌、皮肤基底细胞或皮肤鳞状细胞癌; 9. 患者具有严重的伴随疾病,或研究者认为患不适合参加本研究的其他任何情况。 

Exclusion criteria:

1. Pregnant or lactating women; 2. Patients with single brain metastases who can be operated on; 3. Previous treatment with pyrrolidine maleate; 4. Received chemotherapy, targeted therapy or experimental drugs in the first two weeks, and endocrine therapy in the first seven days; 5. There is a third space effusion (e.g. pleural effusion and ascites) that cannot be controlled by drainage or other parties; 6. Inability to swallow, intestinal obstruction or other factors affecting drug use and absorption; 7. People with allergic constitution or known history of drug components of this program; immunodeficiency disorders include HIV positive test, or other acquired and congenital immunodeficiency disorders with organ transplantation history; 8. Other malignant tumors in the past five years, excluding cured cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin; 9. The patient has a serious concomitant disease, or any other condition that the researcher considers unsuitable for this study. 

研究实施时间:

Study execute time:

From2019-03-01To 2022-05-01 

干预措施:

Interventions:

组别:

病例组

样本量:

48

Group:

Case series

Sample size:

干预措施:

马来酸吡咯替尼片联合标准治疗方案

干预措施代码:

Intervention:

pyrrolidine combined + standard treatment plan

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

哈尔滨 

Country:

China 

Province:

Heilongjiang 

City:

Harbin 

单位(医院):

哈尔滨医科大学附属肿瘤医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Cancer Hospital of Harbin Medical University  

Level of the institution:

Tertiary A Hospital  

测量指标:

Outcomes:

指标中文名:

颅内肿瘤客观缓解率

指标类型:

主要指标 

Outcome:

ORR

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疾病进展时间

指标类型:

次要指标 

Outcome:

TTP

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

放疗时间

指标类型:

次要指标 

Outcome:

time to radiotherapy

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

颅内+颅外肿瘤客观缓解率

指标类型:

次要指标 

Outcome:

ORR

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性

指标类型:

次要指标 

Outcome:

safety

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

N/A

Randomization Procedure (please state who generates the random number sequence and by what method):

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

2023年7月1日以文章形式发表

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Published in the form of an article in July 1, 2023

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

病例记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Case record table

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-01-12
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