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：	ChiCTR2600116892
最近更新日期： Date of Last Refreshed on：	2026-01-18 21:06:35
注册时间： Date of Registration：	2026-01-16 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	中国局部晚期和转移性HR+、HER2-乳腺癌的治疗模式以及医生和患者选择偏好调研
Public title：	Treatment pattern and preferences of locally advanced and metastatic HR+, HER2- breast cancer from a Chinese physician and patient survey
注册题目简写：
English Acronym：
研究课题的正式科学名称：	中国局部晚期和转移性HR+、HER2-乳腺癌的治疗模式以及医生和患者选择偏好调研
Scientific title：	Treatment pattern and preferences of locally advanced and metastatic HR+, HER2- breast cancer from a Chinese physician and patient survey
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：	姚淑贞	研究负责人：	张剑
Applicant：	Shuzhen Yao	Study leader：	Zhang Jian
申请注册联系人电话： Applicant telephone：	+86 133 1179 2739	研究负责人电话： Study leader's telephone：	+86 21 6417 5590
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：	shuzhen.yao@msd.com	研究负责人电子邮件： Study leader's E-mail：	syner2000@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：	上海市徐汇区虹桥路183号A座42层	研究负责人通讯地址：	上海市浦东区康新公路4333号
Applicant address：	Floor 42, Building A, 183 Hongqiao Rd, Xuhui District, Shanghai	Study leader's address：	4333 Kingxin Rd, Pudong District, Shanghai
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：	默沙东(中国)投资有限公司
Applicant's institution：	MSD China Holding Co.,Ltd
研究负责人所在单位：	复旦大学附属肿瘤医院
Affiliation of the Leader：	Fudan University Shanghai Cancer Center

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：	2511-Exp320	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：	复旦大学附属肿瘤医院医学伦理委员会
Name of the ethic committee：	Fudan University Shanghai Cancer Center Ethic Committee
伦理委员会批准日期： Date of approved by ethic committee：	2025-11-14 00:00:00
伦理委员会联系人：	张玮静/丁琳
Contact Name of the ethic committee：	Zhang Weijing/ Ding Lin
伦理委员会联系地址：	上海市徐汇区东安路270号复旦大学附肿医院2号楼2楼216室（徐汇院区）
Contact Address of the ethic committee：	Room 216, 2nd Floor, Building 2, Fudan University Shanghai Cancer Center, 270 Dong'an Rd, Xuhui District, Shanghai
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 21 3477 8299	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：

复旦大学附属肿瘤医院

Primary sponsor：

Fudan University Shanghai Cancer Center

研究实施负责（组长）单位地址：

上海市浦东区康新公路4333号

Primary sponsor's address：

4333 Kingxin Rd, Pudong District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	复旦大学附属肿瘤医院	具体地址：	上海市浦东区康新公路4333号
Institution hospital：	Fudan University Shanghai Cancer Center	Address：	4333 Kingxin Rd, Pudong District, Shanghai

经费或物资来源：

默沙东(中国)投资有限公司

Source(s) of funding：

MSD China Holding 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：

观察性研究

Study type：

Observational study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

横断面

Study design：

Cross-sectional

研究目的：

主要目的和假设：探索中国医生和患者的局部晚期和转移性HR+、HER2-BC的治疗模式分布探索中国医生和患者的局部晚期和转移性HR+、HER2-BC的治疗决策因素次要目的和假设：描述中国医生和患者的局部晚期和转移性HR+、HER2-BC的系统治疗方案描述中国医生和患者的局部晚期和转移性HR+、HER2-BC的系统治疗方案的治疗决策因素探索性目的和假设：描述HCPs的执业特征和领域对其局部晚期和转移性HR+、HER2-BC治疗偏好的影响描述患者的人口统计学因素和临床病理学特征对其局部晚期和转移性HR+、HER2-BC治疗决策的影响

Objectives of Study：

Primary Objective(s) & Hypothesis(es): To explore the distribution of the treatment pattern of locally advanced and metastatic HR+, HER2- BC both from Chinese physicians and patients To explore the treatment decision-making factors of locally advanced and metastatic HR+, HER2- BC both from Chinese physicians and patients Secondary Objective(s) & Hypothesis(es): To describe the systemic treatment regimens of locally advanced and metastatic HR+, HER2- BC in China from Chinese physicians and patients To describe the treatment decision-making factors of locally advanced and metastatic HR+, HER2- BC on the systemic treatment regimens from Chinese physicians and patients Exploratory Objective(s) & Hypothesis(es): To describe the impact of occupational characteristics and territories of HCPs on their treatment preferences of locally advanced and metastatic HR+, HER2- BC To describe the impact of demographic factors and clinicopathological features of patients on their treatment decisions of locally advanced and metastatic HR+, HER2- BC

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

Phase One:
1. Work in a tertiary hospital, including general hospitals and cancer specialist hospitals;
2. Possess at least 10 years of experience in the treatment and research of locally advanced and metastatic HR+ and HER2-BC;
3. The professional rank is chief physician or associate chief physician;
4. Oncologists who have diagnosed and treated at least 10 newly diagnosed patients with locally advanced and metastatic HR+ and HER2-BC in clinical practice over the past 3 months; surgeons who have diagnosed and treated at least 4 newly diagnosed patients with locally advanced and metastatic HR+ and HER2-BC in clinical practice over the past 3 months; radiologists who have diagnosed and treated at least 2 newly diagnosed patients with locally advanced and metastatic HR+ and HER2-BC in clinical practice over the past 3 months;
5. In the past 10 years, served as a member, executive member, vice chairman, chairman, or other similar positions in the breast cancer expert committee, radiotherapy expert committee, or oncology expert committee under the China Anti-Cancer Association (CACA) or the Chinese Society of Clinical Oncology (CSCO).
6. Sign the informed consent form or provide an electronic signature on the consent form for participating in the study.
Phase two:
For physicians,
1. Working in tertiary A hospital, including general hospital and specialized cancer hospital;
2. Having at least 5-year experience of treating and studying locally advanced and metastatic HR+, HER2- BC;
3. Recruiting physicians in terms of chief physician, vice chief physician or attending physician;
4. Oncologists with at least 10 newly diagnosed locally advanced and metastatic HR+, HER2-BC patients in the past 3 months of clinical practice; surgeons with at least 4 newly diagnosed locally advanced and metastatic HR+, HER2- BC patients in the past 3 months of clinical practice; radiologists with at least 2 newly diagnosed locally advanced and metastatic HR+, HER2- BC patients in the past 3 months of clinical practice; 
5. Signing the informed consent or provide an e-signature on the consent form to participate in the study.
For patients with locally advanced and metastatic HR+, HER2- BC, the inclusion criteria 
include: 
1. >=18 years old; 
2. Female;
3. Having a histologically or cytologically documented HR+, HER2- BC(ER or PR positive criteria: Immunohistochemical (IHC) staining shows nuclear staining in at least 1% of tumor cells at varying intensity. HER2 negative criteria: IHC 0 or 1+; if IHC is 2+, in situ hybridization (ISH) must be performed to confirm negative status.); 
4. Having histopathologically confirmed diagnosis of inoperable locally advanced and metastatic HR+, HER2- BC;
5. Within 12 months of start of each line (1st/2nd/3rd/>=4th) of salvage treatment for locally advanced and metastatic HR+, HER2- BC;
6. Patient is able to read and understand the questionnaire in his/her local language;
7. Signing the informed consent or provide an e-signature on the consent form to participate in the study.

排除标准：

1. 如果HCPs不愿意提供参与调研的电子协议; 2. 如果患者的病理学诊断不完善或在参与本研究前5年内曾患其他恶性肿瘤（过去5年内无复发或进展证据，或无需因该恶性肿瘤接受积极治疗的患者可纳入研究。） 3. 或不愿意提供书面知情同意书.

Exclusion criteria：

1. The HCPs will be excluded if they are unwilling to provide electronic agreement to participate in the survey. 2. The patients will be excluded if their pathological diagnosis are incomplete or had other malignancies within five years prior to participation in this study(Those patients who have had no evidence of recurrence or progression or has required active treatment for that malignancy within the past 5 years can be included.) 3. or is unwilling to provide written informed consent.

研究实施时间：

Study execute time：

从 From 2026-01-20 00:00:00至 To 2028-01-20 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-02-01 00:00:00 至 To 2027-06-30 00:00:00

干预措施：

Interventions：

组别：	观察组	样本量：	320
Group：	Observation Group	Sample size：	320
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	复旦大学附属肿瘤医院	单位级别：	三甲
Institution hospital：	Fudan University Shanghai Cancer Center	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	山西省	市(区县)：
Country：	China	Province：	Shanxi	City：
单位(医院)：	山西省肿瘤医院	单位级别：	三甲
Institution hospital：	Shanxi Cancer Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	陕西省	市(区县)：
Country：	China	Province：	Shaanxi	City：
单位(医院)：	西安交通大学附属第二医院	单位级别：	三甲
Institution hospital：	Xi'an Jiaotong University Second Affiliated Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	中国医生和患者的局部晚期和转移性HR+、HER2-BC的治疗模式分布	指标类型：	主要指标
Outcome：	The distribution of the treatment pattern of locally advanced and metastatic HR+, HER2- BC both from Chinese physicians and patients	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	中国医生和患者的局部晚期和转移性HR+、HER2-BC的治疗决策因素	指标类型：	主要指标
Outcome：	The treatment decision-making factors of locally advanced and metastatic HR+, HER2- BC both from Chinese physicians and patients	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	中国医生和患者的局部晚期和转移性HR+、HER2-BC的系统治疗方案	指标类型：	次要指标
Outcome：	The systemic treatment regimens of locally advanced and metastatic HR+, HER2- BC in China from Chinese physicians and patients	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	中国医生和患者的局部晚期和转移性HR+、HER2-BC的系统治疗方案的治疗决策因素	指标类型：	次要指标
Outcome：	The treatment decision-making factors of locally advanced and metastatic HR+, HER2- BC on the systemic treatment regimens from Chinese physicians and patients	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	HCPs的执业特征和领域对其局部晚期和转移性HR+、HER2-BC治疗偏好的影响	指标类型：	附加指标
Outcome：	The impact of occupational characteristics and territories of HCPs on their treatment preferences of locally advanced and metastatic HR+, HER2- BC	Type：	Additional indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	述患者的人口统计学因素和临床病理学特征对其局部晚期和转移性HR+、HER2-BC治疗决策的影响	指标类型：	附加指标
Outcome：	The impact of demographic factors and clinicopathological features of patients on their treatment decisions of locally advanced and metastatic HR+, HER2- BC	Type：	Additional 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：	None	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	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		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）：	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：	数据通过电⼦问卷平台收集
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	The data was collected through an electronic questionnaire platform.
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2026-01-16 10:04:22