A Multi-center, Observational Study to Describe the Treatment Situation of Chinese County Population With HER2+ & HR+/HER2- Breast Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Enrollment
- 2500
- Locations
- 2
- Primary Endpoint
- the treatment pattern in HER2+, and HR+HER2- early and advanced breast cancer patients in county in each cohort
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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
- •Age ≥ 18 years at the time of enrollment
- •Histologically confirmed HER2+ breast cancer
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
the treatment pattern in HER2+, and HR+HER2- early and advanced breast cancer patients in county in each cohort
Time Frame: 1 year
Different treatment patterns in each cohort
Secondary Outcomes
- the referral behavior in county(1 year)
- the duration of anti-HER2 therapy in advanced breast cancer(1 year)
- he relationship between recurrent risk and OFS, chemotherapy and OFS(1 year)
- the duration of medical OFS in early breast cancer(1 year)