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临床试验/NCT05544123
NCT05544123招募中不适用

A Multi-center, Observational Study to Describe the Treatment Situation of Chinese County Population With HER2+ & HR+/HER2- Breast Cancer

The First Affiliated Hospital of Xinxiang Medical College2 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2022年9月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,500
试验地点
2
主要终点
the treatment pattern in HER2+, and HR+HER2- early and advanced breast cancer patients in county in each cohort

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • De Novo or recurrent metastatic breast cancer
  • Complete medical history information
  • 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

排除标准

  • 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

结局指标

主要结局

the treatment pattern in HER2+, and HR+HER2- early and advanced breast cancer patients in county in each cohort

时间窗: 1 year

Different treatment patterns in each cohort

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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