The Treatment Situation of Chinese County Population With Breast Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort 1 HER2+ EBC newly diagnosed or completed definitive breast surgery |
Other: pathological stage
breast cancer molecular subtyping and pathological TNM stage
|
| Cohort 2 HR+ HER2- EBC newly diagnosed or completed definitive breast surgery |
Other: pathological stage
breast cancer molecular subtyping and pathological TNM stage
|
| Cohort 3 HER2+ ABC De novo or relapsed from adjuvant therapy |
Other: pathological stage
breast cancer molecular subtyping and pathological TNM stage
|
| Cohort 4 HR+ HER2- ABC De novo or relapsed from adjuvant therapy |
Other: pathological stage
breast cancer molecular subtyping and pathological TNM stage
|
Outcome Measures
Primary Outcome Measures
- the treatment pattern in HER2+, and HR+HER2- early and advanced breast cancer patients in county in each cohort [1 year]
Different treatment patterns in each cohort
Secondary Outcome Measures
- the referral behavior in county [1 year]
To describe the referral behavior in county (Among all patients)
- he relationship between recurrent risk and OFS, chemotherapy and OFS [1 year]
To explore the relationship between recurrent risk and OFS, chemotherapy and OFS
- the duration of medical OFS in early breast cancer [1 year]
To explore the duration of medical OFS in early breast cancer
- the duration of anti-HER2 therapy in advanced breast cancer [1 year]
To explore the duration of anti-HER2 therapy in advanced breast cancer
Other Outcome Measures
- Proportion of re-biopsy of recurrent/metastatic disease [1 year]
Proportion of re-biopsy of recurrent/metastatic disease
- Rate of HER2 testing in county [1 year]
Rate of HER2 testing in county (IHC and FISH) (Among all patients)
- Percentage of Her-2 low expression among HR+HER2- early and advanced breast cancer (Cohort 2 and Cohort 4) [1 year]
Percentage of Her-2 low expression among HR+HER2- early and advanced breast cancer (Cohort 2 and Cohort 4)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Xinxiang Medical University | Xinxiang | Henan | China | 453100 |
Sponsors and Collaborators
- The First Affiliated Hospital of Xinxiang Medical College
- AstraZeneca
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ESR-21-21505