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Trial Title:
The Treatment Situation of Chinese County Population With Breast Cancer
NCT ID:
NCT05544123
Condition:
Breast Cancer
Breast Carcinoma
Breast Tumor
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
pathological stage
Description:
breast cancer molecular subtyping and pathological TNM stage
Arm group label:
Cohort 1 HER2+ EBC
Arm group label:
Cohort 2 HR+ HER2- EBC
Arm group label:
Cohort 3 HER2+ ABC
Arm group label:
Cohort 4 HR+ HER2- ABC
Summary:
The study is a multi-center, non-interventional, prospective observational study which
enrols 2500 breast cancer patients from China county area. The purpose of this study is
to be aware of the real-world data of the current breast cancer diagnosis and treatment
model in the county. It aims to understand the gap between the county and the SOC in the
diagnosis and treatment.
Detailed description:
The study is a multi-center, non-interventional, prospective observational study which
enrols 2500 breast cancer patients from China county area. The patients will be divided
into four cohorts by HR/HER2 status and early/late stage without prespecified minimum or
maximum limit of patient number for each cohort.
The potential study subjects will be identified by the investigators by face-to-face
visit. During this process approximately 2500 subjects will be enrolled in 1 year. All
subjects will be sign informed consent and recorded for demographic characteristics,
medical history, treatment history, treatment hospital, pathologic diagnosis, receptor
status, therapeutic regimen, etc at the beginning of enrollment. Normally, there will be
4 visits for EBC and 6 visits for ABC in hospitals during yearlong follow-up period. All
visits are according to the standard frequency of clinical follow-up. If the patient does
not come to the hospital for follow-up on a regular basis, we will follow-up by telephone
inquiries, etc.The potential study subjects will be identified by the investigators by
face-to-face visit. During this process approximately 2500 subjects will be enrolled in 1
year. All subjects will be sign informed consent and recorded for demographic
characteristics, medical history, treatment history, treatment hospital, pathologic
diagnosis, receptor status, therapeutic regimen, etc at the beginning of enrollment.
Normally, there will be 4 visits for EBC and 6 visits for ABC in hospitals during
yearlong follow-up period. All visits are according to the standard frequency of clinical
follow-up. If the patient does not come to the hospital for follow-up on a regular basis,
we will follow-up by telephone inquiries, etc.
Criteria for eligibility:
Study pop:
A total of 2500 breast cancer patients will be recruited in this study. The entire
subjects are spread over 13 Provinces (Henan province, Hebei province, Hunan Province
etc.) and 2 autonomous regions (Inner Mongolia Autonomous Region and Guangxi Zhuang
Autonomous Region). In order to acquire adequate treatment patterns choices in China
county area. Data collection and analysis are needed in the corresponding population.
Data collection and analysis are needed in the corresponding population. The entire
subjects contain in this study are spread over 13 Provinces (Henan province, Hebei
province, Hunan Province etc.) and 2 autonomous regions (Inner Mongolia Autonomous Region
and Guangxi Zhuang Autonomous Region).
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
Cohort 1
- Age ≥ 18 years at the time of enrollment
- Histologically confirmed HER2+ breast cancer
- Newly diagnosed or completed definitive early breast surgery
- Complete medical history information
Cohort 2
- Age ≥ 18 years at the time of enrollment
- Histologically confirmed HR+ HER2- breast cancer
- Newly diagnosed or completed definitive early breast surgery
- Complete medical history information
Cohort 3
- Age ≥ 18 years at the time of enrollment
- Histologically confirmed HER2+ breast cancer
- De Novo or recurrent metastatic breast cancer
- Complete medical history information
Cohort 4
- Age ≥ 18 years at the time of enrollment
- Histologically confirmed HR+ HER2- breast cancer
- De Novo or recurrent metastatic breast cancer
- Complete medical history information
Exclusion Criteria:
Cohort 1
- Participated in other Intervention drug clinical trials within 4 weeks before
admission Cohort 2
- Participated in other Intervention drug clinical trials within 4 weeks before
admission Cohort 3
- Patients with HER2 + advanced breast cancer who have received more than 2 lines of
therapy
- Participated in other Intervention drug clinical trials within 4 weeks before
admission Cohort 4
- Patients with HR+ HER2- advanced breast cancer who have received more than 2 lines
of therapy
- Participated in other Intervention drug clinical trials within 4 weeks before
admission
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Xinxiang Medical University
Address:
City:
Xinxiang
Zip:
453100
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ping Lu, Doctor
Phone:
13598722864
Email:
lupingdoctor@126.com
Contact backup:
Last name:
Yinghua M Ji, Master
Phone:
13663030446
Email:
54234317@qq.com
Facility:
Name:
路平
Address:
City:
Xinxiang
Zip:
453100
Country:
China
Status:
Recruiting
Contact:
Last name:
Ping Lu
Phone:
13598722864
Email:
lupingdoctor@126.com
Start date:
September 29, 2022
Completion date:
September 2024
Lead sponsor:
Agency:
The First Affiliated Hospital of Xinxiang Medical College
Agency class:
Other
Collaborator:
Agency:
AstraZeneca
Agency class:
Industry
Source:
The First Affiliated Hospital of Xinxiang Medical College
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05544123
