中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2400090076
最近更新日期： Date of Last Refreshed on：	2024-09-24 08:37:42
注册时间： Date of Registration：	2024-09-24 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	达尔西利联合芳香化酶抑制剂和卡培他滨新辅助治疗 HR 阳性/HER2 阴性早期乳腺癌的开放、单臂、多中心研究
Public title：	Dalcilib combined with aromatase inhibitors and capecitabine neoadjuvant therapy Open, single arm, multi arm treatment of HR positive/HER2 negative early breast cancer Central research
注册题目简写：
English Acronym：
研究课题的正式科学名称：	达尔西利联合芳香化酶抑制剂和卡培他滨新辅助治疗 HR 阳性/HER2 阴性早期乳腺癌的开放、单臂、多中心研究
Scientific title：	Dalcilib combined with aromatase inhibitors and capecitabine neoadjuvant therapy Open, single arm, multi arm treatment of HR positive/HER2 negative early breast cancer Central research
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：	黄小钒	研究负责人：	韩忠华
Applicant：	Huang Xiaofan	Study leader：	Han Zhonghua
申请注册联系人电话： Applicant telephone：	+86 185 5915 5686	研究负责人电话： Study leader's telephone：	+86 134 5910 9046
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：	693282593@qq.com	研究负责人电子邮件： Study leader's E-mail：	zhhan@fjmu.edu.cn
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：	福建省福州市鼓楼区新权路29号福建医科大学附属协和医院乳腺外科	研究负责人通讯地址：	福建省福州市鼓楼区新权路29号福建医科大学附属协和医院乳腺外科
Applicant address：	Breast Surgery Department, Fujian Medical University Affiliated Union Hospital, No. 29 Xinquan Road,	Study leader's address：	Breast Surgery Department, Fujian Medical University Affiliated Union Hospital, No. 29 Xinquan Road,
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：	福建医科大学附属协和医院
Applicant's institution：	Fujian Medical University Affiliated Union Hospital
研究负责人所在单位：	福建医科大学附属协和医院
Affiliation of the Leader：	Fujian Medical University Affiliated Union Hospital

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	2024YF023-02	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	福建医科大学附属协和医院伦理委员会
Name of the ethic committee：	Ethics Committee of Union Hospital Affiliated to Fujian Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2024-05-28 00:00:00
伦理委员会联系人：	赖晓玉
Contact Name of the ethic committee：	Lai Xiaoyu
伦理委员会联系地址：	福建省福州市鼓楼区新权路29号
Contact Address of the ethic committee：	29 Xinquan Road, Gulou District, Fuzhou, Fujian
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 591 8621 8329	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：

福建医科大学附属协和医院

Primary sponsor：

Fujian Medical University Affiliated Union Hospital

研究实施负责（组长）单位地址：

福建省福州市鼓楼区新权路29号福建医科大学附属协和医院

Primary sponsor's address：

Fujian Medical University Affiliated Union Hospital, No. 29 Xinquan Road,

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	福建	市(区县)：
Country：	China	Province：	Fujian	City：
单位(医院)：	福建医科大学附属协和医院	具体地址：	福建省福州市鼓楼区新权路29号福建医科大学附属协和医院
Institution hospital：	Fujian Medical University Affiliated Union Hospital	Address：	Fujian Medical University Affiliated Union Hospital, No. 29 Xinquan Road,

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-funded

研究疾病：

乳腺癌

Target disease：

HR positive/HER2 negative early breast cancer

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

II期临床试验

Study phase：

2

研究设计：

单臂

Study design：

Single arm

研究目的：

探索 CDK4/6 抑制剂达尔西利联合芳香化酶抑制剂和卡培他滨新辅助治疗 HR 阳性 HER2 阴性乳腺癌有效性及安全性

Objectives of Study：

Exploring the combination of CDK4/6 inhibitor Darcilib, aromatase inhibitor, and capecitabine neoadjuvant therapy for HR positivity efficacy and safety of HER2 negative breast cancer

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1:   For postmenopausal or premenopausal/perimenopausal female patients aged ≥ 18 years and ≤ 75 years, one of the following conditions must be met: Previously underwent bilateral oophorectomy, or aged ≥ 60 years o

2:   All patients are estrogen receptor (ER) positive (>10%), regardless of PR expression levels, HER2 receptor negative invasive breast cancer. Follow the 2018 ASCO-CAP HER2 Negative Interpretation Guidelines standard. Confirmed by the pathology laboratory, the immunohistochemical (IHC) score is 0+, Or 2+and negative in situ hybridization (ISH) detection (HER-2/CEP17 ratio<2.0)

3:   Newly treated patients in stages II-III who meet the AJCC 8th edition criteria for tumor staging

4:   Inability to tolerate intravenous chemotherapy, suitable for special populations with oral chemotherapy combined with endocrine neoadjuvant therapy 5. It is known that there are no severe hypersensitivity reactions to compounds or endocrine therapies similar to the investigational drug and its excipients. 6. The Eastern Cancer Collaborative Group (ECOG) physical condition score is ECOG 0-1

5:   It is known that there is no severe hypersensitivity reaction to compounds or endocrine therapies similar to the investigational drug and its excipients;

6:   (ECOG) physical condition score is ECOG 0-1;

7:   Women of childbearing age must undergo a serum pregnancy test within 28 days before enrollment, and the result is negative. Male/female patients are willing to use a medically recognized and efficient contraceptive method during the study period and within 1 year after the last administration of the study medication;

8:   Non pregnant or non lactating female patients;

9:   Not simultaneously participating in other ongoing research;

10:   The functional level of organs must meet the following requirements: bone marrow function ANC ≥ 1.5 × 109/L (growth factor not used within 14 days); PLT ≥ 100 × 109/L (no corrective treatment used within 7 days); Hb ≥ 100 g/L (no corrective treatment used within 7 days); Liver and kidney function TBIL ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN (ALT and AST ≤ 5 × ULN in patients with liver metastasis); BUN and Cr ≤ 1.5 × ULN with creatinine clearance rate ≥ 50 mL/min (Cockcroft Gault formula); QT interval of lead electrocardiogram ≤ 480 ms;

11:   Voluntarily participate in this study, sign informed consent, have good compliance, and are willing to cooperate with follow-up.

排除标准：

1: 既往接受过任何形式的抗肿瘤治疗（化疗、放疗、分子靶向治疗、内分泌治疗等）； 2: 同时接受其他方案规定之外的任何抗肿瘤治疗； 3: 双侧乳腺癌、炎性乳腺癌或隐匿性乳腺癌； 4: IV 期乳腺癌； 5: 既往 5 年内出现过其它恶性肿瘤； 6: 严重心肝肾等重要器官功能不全者； 7: 无法吞咽、慢性腹泻和肠梗阻，存在影响药物服用和吸收的多种因素； 8: 已知对本方案药物组分有过敏史者；有免疫缺陷病史，包括 HIV 检测阳性，HCV、活动性乙型病毒性肝炎或患有其他获得性、先天性免疫缺陷疾病，或有器官移植史； 9: 根据研究者的判断，有严重的危害患者安全、或影响患者完成研究的伴随疾病（包括但不限于药物无法控制的严重高血压、严重的糖尿病、活动性感染等）； 10: 既往有明确的神经或精神障碍史，包括癫痫或痴呆。研究者认为患者不适合参加本研究的其他任何情况。

Exclusion criteria：

1: Previously received any form of anti-tumor therapy (chemotherapy, radiation therapy, molecular targeted therapy, endocrine therapy, etc.) 2: Simultaneously receiving any anti-tumor treatment other than those specified in other protocols 3: Bilateral breast cancer, inflammatory breast cancer or occult breast cancer 4: Stage IV breast cancer 5: Other malignant tumors have appeared within the past 5 years 6: Severe dysfunction of important organs such as heart, liver, and kidney 7: Difficulty in swallowing, chronic diarrhea, and intestinal obstruction, with multiple factors affecting medication administration and absorption 8: Individuals with a known history of allergies to the drug components of this protocol Having a history of immunodeficiency, including HIV testing positive, HCV Active hepatitis B or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation 9: According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study (including but not limited to serious hypertension, serious diabetes, active infection, etc. that cannot be controlled by drugs) 10: Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia. The researchers believe that the patient is not suitable to participate in any other circumstances of this study.

研究实施时间：

Study execute time：

从 From 2024-09-28 00:00:00至 To 2028-05-28 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-09-28 00:00:00 至 To 2028-05-28 00:00:00

干预措施：

Interventions：

组别：	达尔西利联合芳香化酶抑制剂和卡培他滨新辅助治疗	样本量：	30
Group：	Dalcilib combined with aromatase inhibitors and capecitabine neoadjuvant therapy	Sample size：	30
干预措施：	达尔西利联合芳香化酶抑制剂和卡培他滨新辅助治疗	干预措施代码：
Intervention：	Dalcilib combined with aromatase inhibitors and capecitabine neoadjuvant therapy	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	福建	市(区县)：
Country：	China	Province：	Fujian	City：
单位(医院)：	福建医科大学附属协和医院	单位级别：	三甲
Institution hospital：	Fujian Medical University Affiliated Union Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	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：	Ki67	指标类型：	次要指标
Outcome：	Ki67	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	pCR	指标类型：	次要指标
Outcome：	pCR	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：

标本中文名：	无	组织：
Sample Name：	NA	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

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	岁 years
最大 Max age	75	岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	否No
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）：	NA
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	NA
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：	NA
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	NA
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2024-09-24 08:37:35