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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 HER2+ EBC | newly diagnosed or completed definitive breast surgery |
| |
| Cohort 2 HR+ HER2- EBC | newly diagnosed or completed definitive breast surgery |
| |
| Cohort 3 HER2+ ABC | De novo or relapsed from adjuvant therapy |
| |
| Cohort 4 HR+ HER2- ABC | De novo or relapsed from adjuvant therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pathological stage | Other | breast cancer molecular subtyping and pathological TNM stage |
|
| Measure | Description | Time Frame |
|---|---|---|
| the treatment pattern in HER2+, and HR+HER2- early and advanced breast cancer patients in county in each cohort | Different treatment patterns in each cohort | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| the referral behavior in county | To describe the referral behavior in county (Among all patients) | 1 year |
| he relationship between recurrent risk and OFS, chemotherapy and OFS | To explore the relationship between recurrent risk and OFS, chemotherapy and OFS |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of re-biopsy of recurrent/metastatic disease | Proportion of re-biopsy of recurrent/metastatic disease | 1 year |
| Rate of HER2 testing in county | Rate of HER2 testing in county (IHC and FISH) (Among all patients) |
Inclusion Criteria:
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Exclusion Criteria:
Cohort 1
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xinxiang Medical University | Not yet recruiting | Xinxiang | Henan | 453100 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 1 year |
| the duration of medical OFS in early breast cancer | To explore the duration of medical OFS in early breast cancer | 1 year |
| the duration of anti-HER2 therapy in advanced breast cancer | To explore the duration of anti-HER2 therapy in advanced breast cancer | 1 year |
| 1 year |
| Percentage of Her-2 low expression among HR+HER2- early and advanced breast cancer (Cohort 2 and Cohort 4) | Percentage of Her-2 low expression among HR+HER2- early and advanced breast cancer (Cohort 2 and Cohort 4) | 1 year |
| 路平 | Recruiting | Xinxiang | Henan | 453100 | China |
|
| D017437 |
| Skin and Connective Tissue Diseases |