The Treatment Situation of Chinese County Population With Breast Cancer
- Conditions
- Breast CancerBreast CarcinomaBreast Tumor
- Interventions
- Other: pathological stage
- Registration Number
- NCT05544123
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2500
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
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 2 HR+ HER2- EBC pathological stage newly diagnosed or completed definitive breast surgery Cohort 1 HER2+ EBC pathological stage newly diagnosed or completed definitive breast surgery Cohort 3 HER2+ ABC pathological stage De novo or relapsed from adjuvant therapy Cohort 4 HR+ HER2- ABC pathological stage De novo or relapsed from adjuvant therapy
- Primary Outcome Measures
Name Time Method 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
Name Time Method the referral behavior in county 1 year To describe the referral behavior in county (Among all patients)
the duration of anti-HER2 therapy in advanced breast cancer 1 year To explore the duration of anti-HER2 therapy in advanced breast cancer
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
Trial Locations
- Locations (2)
The First Affiliated Hospital of Xinxiang Medical University
🇨🇳Xinxiang, Henan, China
路平
🇨🇳Xinxiang, Henan, China