The Treatment Situation of Chinese County Population With Breast Cancer

The First Affiliated Hospital of Xinxiang Medical College

Status

Enrolling

Conditions

Breast Cancer

Breast Tumor

Breast Carcinoma

Treatments

Other: pathological stage

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05544123

ESR-21-21505

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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