Breast Cancer, Breast Carcinoma, Breast Tumor
Conditions
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.
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.
Interventions
OTHERpathological stage
breast cancer molecular subtyping and pathological TNM stage
Sponsors
AstraZeneca
The First Affiliated Hospital of Xinxiang Medical College
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 referral behavior in county | 1 year | To describe the referral behavior in county (Among all patients) |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Rate of HER2 testing in county | 1 year | Rate of HER2 testing in county (IHC and FISH) (Among all patients) |
| Proportion of re-biopsy of recurrent/metastatic disease | 1 year | Proportion of re-biopsy of recurrent/metastatic disease |
Countries
China
Outcome results
None listed