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：	ChiCTR2500113953
最近更新日期： Date of Last Refreshed on：	2025-12-04 16:58:59
注册时间： Date of Registration：	2025-12-04 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	达尔西利联合内分泌对比化疗续贯内分泌治疗高危HR+/HER2-复发转移性乳腺癌的开放、随机对照、III期研究
Public title：	An Open-Label, Randomized Controlled, Phase III Study of Dalpiciclib Plus Endocrine Therapy Versus Chemotherapy Followed by Endocrine Therapy in High-Risk HR+/HER2- Recurrent or Metastatic Breast Cancer
注册题目简写：
English Acronym：
研究课题的正式科学名称：	达尔西利联合内分泌对比化疗续贯内分泌治疗高危HR+/HER2-复发转移性乳腺癌的开放、随机对照、III期研究
Scientific title：	An Open-Label, Randomized Controlled, Phase III Study of Dalpiciclib Plus Endocrine Therapy Versus Chemotherapy Followed by Endocrine Therapy in High-Risk HR+/HER2- Recurrent or Metastatic Breast Cancer
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：	李慧慧	研究负责人：	李慧慧
Applicant：	Li Huihui	Study leader：	Li Huihui
申请注册联系人电话： Applicant telephone：	+86 155 5310 3209	研究负责人电话： Study leader's telephone：	+86 155 5310 3209
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：	15553103209@163.com	研究负责人电子邮件： Study leader's E-mail：	15553103209@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：	山东省济南市槐荫区济兖路440号	研究负责人通讯地址：	山东省济南市槐荫区济兖路440号
Applicant address：	440 Jiyan Road, Huaiyin District, Ji'nan, Shandong	Study leader's address：	440 Jiyan Road, Huaiyin District, Ji'nan, Shandong
申请注册联系人邮政编码： Applicant postcode：	250017	研究负责人邮政编码： Study leader's postcode：	250017
申请人所在单位：	山东第一医科大学附属肿瘤医院
Applicant's institution：	Cancer Hospital of Shandong First Medical University
研究负责人所在单位：	山东第一医科大学附属肿瘤医院
Affiliation of the Leader：	Cancer Hospital of Shandong First Medical University

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：	SDZLEC2025-432-02	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：	山东第一医科大学附属肿瘤医院伦理委员会
Name of the ethic committee：	Ethics Committee of the Affiliated Tumor Hospital of Shandong First Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2025-11-10 00:00:00
伦理委员会联系人：	宋玲玲
Contact Name of the ethic committee：	Song Lingling
伦理委员会联系地址：	山东省济南市槐荫区济兖路440号
Contact Address of the ethic committee：	440 Jiyan Road, Huaiyin District, Ji'nan, Shandong
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 531 6762 6929	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：

山东第一医科大学附属肿瘤医院

Primary sponsor：

Cancer Hospital of Shandong First Medical University

研究实施负责（组长）单位地址：

山东省济南市槐荫区济兖路440号

Primary sponsor's address：

440 Jiyan Road, Huaiyin District, Ji'nan, Shandong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	山东	市(区县)：	济南
Country：	China	Province：	Shandong	City：	Ji'nan
单位(医院)：	山东第一医科大学附属肿瘤医院	具体地址：	山东省济南市槐荫区济兖路440号
Institution hospital：	Cancer Hospital of Shandong First Medical University	Address：	440 Jiyan Road, Huaiyin District, Ji'nan, Shandong

经费或物资来源：

恒瑞医药股份有限公司

Source(s) of funding：

Hengrui Pharmaceutical Co., Ltd.

研究疾病：

乳腺癌

Target disease：

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：

上市后药物

Study phase：

4

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

主要研究目的为评估达尔西利联合内分泌对比化疗续贯内分泌治疗两组方案治疗高危HR+/HER2-晚期乳腺癌的疗效与安全性

Objectives of Study：

The primary objective of this study is to evaluate the efficacy and safety of two treatment regimens, namely dalpiciclib combined with endocrine therapy versus chemotherapy followed by endocrine therapy, in the treatment of high-risk HR+/HER2- advanced 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.Postmenopausal, premenopausal, or perimenopausal female patients aged >=18 years.
2.Female patients with pathologically confirmed hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, who are not eligible for curative-intent surgical resection or radiotherapy.
3.Eastern Cooperative Oncology Group (ECOG) performance status score of 0–2.
4.No prior systemic therapy received for the recurrent/metastatic stage, and presence of indications for chemotherapy; symptomatic visceral metastases, rapidly progressive disease, or visceral disease requiring urgent intervention are permitted. If any clinical signs or symptoms of visceral crisis are present, at least one of the following conditions must be met: pleural effusion; ascites; abdominal pain caused by liver or peritoneal metastases; dyspnea caused by pleural effusion or pulmonary lymphangitis; elevated liver enzymes (> 2 × upper limit of normal [ULN]); rapidly elevated bilirubin > 1.5 × ULN in the absence of Gilbert’s syndrome or biliary obstruction; pathologically confirmed bone marrow metastases.
5.Sufficient bone marrow function, defined as follows:a) Absolute neutrophil count (ANC) >= 1,500/mm^3(1.5 × 10^9/L) (no growth factor used within 14 days);b) Platelet count (PLT) >= 100,000/mm^3(100 × 10^9/L) (no corrective treatment used within 7 days);c) Hemoglobin (Hb) >=8 g/dL (80 g/L) (no corrective treatment used within 14 days).
6.For patients with brain metastases, there must be other evaluable disease sites, and at least one of the following conditions must be satisfied: (a)Untreated brain metastases that do not require immediate local therapy; (b)Previously treated brain metastases.
7.For premenopausal female subjects or those who have not undergone surgical sterilization, a serum pregnancy test must be performed within 7 days before the first dose of study treatment, with a negative result. Additionally, they must be willing to either abstain from sexual activity or use a medically approved highly effective contraceptive method after signing the informed consent form, during the study period, and for 1 year after the last dose of study treatment.
8.Voluntary participation in the study, signing of the informed consent form, good compliance, and willingness to cooperate with follow-up.

排除标准：

1.既往使用过CDK4/6抑制剂治疗的患者。 2.辅助内分泌治疗2年内复发的患者。 3.同时接受其他抗肿瘤治疗（如有抗肿瘤成分的中药或中成药等）。 4.无论复发转移或新发IV期，存在单纯骨转移患者。 5.活动性脑转移患者。 6.人类免疫缺陷病毒（HIV）感染或已知有获得性免疫缺陷综合征（艾滋病），乙肝表面抗原阳性且HBV DNA >=2000 IU/ml，丙型肝炎（丙肝抗体阳性，且HCV-RNA高于分析方法的检测下限）或合并乙肝和丙肝共同感染。 7.入组前6个月出现以下情况：心肌梗死、严重/不稳定型心绞痛、NYHA 2级以上心功能不全、 >=2级的持续心律失常（根据NCI CTCAE 5.0版）、任何级别的房颤、冠状/周边动脉搭桥术、症状性充血性心力衰竭、脑血管意外（包括一过性脑缺血发作）或症状性肺栓塞以及新发血栓。 8.首次用药前4周内并发重度感染（如：根据临床诊疗规范需要静脉滴注抗生素、抗真菌或抗病毒药物），或在筛选期间/首次给药前出现不明原因的发热＞38.5℃。 9.无法吞咽、肠梗阻或存在影响药物服用和吸收的其他因素。 10.已知对方案联合治疗药物及其任何辅料过敏。 11.已知异体器官移植史或异体造血干细胞移植史。 12.已知有精神类药物滥用或吸毒史。 13.妊娠期或哺乳期的女性患者。 14.研究者认为受试者不适合参加本研究的任何其他情况。

Exclusion criteria：

1.Patients with a history of CDK4/6 inhibitor treatment. 2.Patients who experienced recurrence within 2 years of adjuvant endocrine therapy. 3.Patients receiving concurrent anti-tumor therapy (e.g., traditional Chinese medicines or proprietary Chinese medicines containing anti-tumor components). 4.Patients with isolated bone metastases, regardless of whether the disease is recurrent/metastatic or newly diagnosed stage IV breast cancer. 5.Patients with active brain metastases. 6.Patients with human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); positive hepatitis B surface antigen (HBsAg) with hepatitis B virus deoxyribonucleic acid (HBV DNA) >= 2000 IU/ml; hepatitis C (positive hepatitis C antibody with hepatitis C virus ribonucleic acid (HCV-RNA) above the lower limit of detection of the analytical method); or concurrent hepatitis B and hepatitis C co-infection. 7.Occurrence of any of the following conditions within 6 months before enrollment: myocardial infarction, severe/unstable angina pectoris, New York Heart Association (NYHA) class >=2 heart failure, persistent arrhythmia of grade ≥ 2 (per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 5.0), atrial fibrillation of any grade, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack), symptomatic pulmonary embolism, or new-onset thrombosis. 8.Severe infection within 4 weeks before the first dose of study treatment (e.g., requiring intravenous administration of antibiotics, antifungals, or antivirals in accordance with clinical practice guidelines); or unexplained fever > 38.5°C during screening or before the first dose. 9.Inability to swallow, intestinal obstruction, or other factors that affect drug administration and absorption. 10.Known hypersensitivity to any of the drugs used in the combined treatment regimen of the study or any of their excipients. 11.Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 12.Known history of psychotropic substance abuse or drug addiction. 13.Pregnant or lactating female patients. 14.Any other conditions deemed by the investigator to make the subject unsuitable for participation in the study.

研究实施时间：

Study execute time：

从 From 2025-12-15 00:00:00至 To 2029-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-12-15 00:00:00 至 To 2027-12-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	110
Group：	experimental group	Sample size：	110
干预措施：	达尔西利+内分泌治疗	干预措施代码：
Intervention：	Dalpiciclib+Endocrine therapy	Intervention code：

组别：	对照组	样本量：	110
Group：	control group	Sample size：	110
干预措施：	化疗续贯内分泌治疗	干预措施代码：
Intervention：	Chemotherapy followed by endocrine therapy	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	山东	市(区县)：	济南
Country：	China	Province：	Shandong	City：	Ji'nan
单位(医院)：	山东第一医科大学附属肿瘤医院	单位级别：	三级甲等
Institution hospital：	Cancer Hospital of Shandong First Medical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	无进展生存时间	指标类型：	主要指标
Outcome：	Progression Free Survival	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	总生存期	指标类型：	次要指标
Outcome：	Overall survival, OS	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	总生存率	指标类型：	次要指标
Outcome：	Overall survival rate	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	治疗响应时间	指标类型：	次要指标
Outcome：	Time to Response	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	客观缓解率	指标类型：	次要指标
Outcome：	objective response rate, 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：	缓解持续时间	指标类型：	次要指标
Outcome：	Duration of relief, DoR	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	临床获益率	指标类型：	次要指标
Outcome：	Clinical benefit rate,CBR	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：

标本中文名：	血液	组织：
Sample Name：	Blood	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：

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）：

本研究将采用中央随机系统进行随机化管理。参加本试验各研究中心的研究者，将登录随机系统获取随机号。随机前，受试者和随机号并不存在一一对应关系。但完成随机号取号后，受试者和随机号一一对应关系随之确定。研究者需确认受试者与随机号的一一对应关系并严格根据随机结果安排治疗。每个受试者将拥有唯一的随机号。

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

This study will adopt a central randomization system for randomization management. Researchers from each research center participating in this trial will log in to the randomization system to obtain random numbers. Before randomization, there is no one-to-one correspondence between the subjects and the random numbers. However, after the random numbers are obtained, the one-to-one correspondence between the subjects and the random numbers is determined accordingly. The researchers need to confirm the one-to-one correspondence between the subjects and the random numbers and strictly arrange the treatment according to the randomization results. Each subject will have a unique random number.

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：	无，开放标签
Blinding：	None, open-label
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）：	无
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	None
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：	使用病例记录表(Case Record Form, CRF)和电子采集和管理系统(Electronic Data Capture, EDC)
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Use case record form (Case Record Form, CRF) and electronic data capture and management system (Electronic Data Capture, EDC).
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：	2025-12-04 16:58:53