The Treatment Situation of Chinese County Population With Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05544123
• Other study ID #: ESR-21-21505
• Status: Recruiting
• Start date: September 29, 2022
• Est. completion date: September 2024

Study information

• Verified date: January 2023
• Source: The First Affiliated Hospital of Xinxiang Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: September 2024
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Carcinoma
• Breast Neoplasms
• Breast Tumor

Intervention

Other:
• pathological stage
breast cancer molecular subtyping and pathological TNM stage

Locations

Country	Name	City	State
China	??	Xinxiang	Henan
China	The First Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Xinxiang Medical College	AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of re-biopsy of recurrent/metastatic disease	Proportion of re-biopsy of recurrent/metastatic disease	1 year
Other	Rate of HER2 testing in county	Rate of HER2 testing in county (IHC and FISH) (Among all patients)	1 year
Other	Percentage of Her-2 low expression among HR+HER2- early and advanced breast cancer (Cohort 2 and Cohort 4)	Percentage of Her-2 low expression among HR+HER2- early and advanced breast cancer (Cohort 2 and Cohort 4)	1 year
Primary	the treatment pattern in HER2+, and HR+HER2- early and advanced breast cancer patients in county in each cohort	Different treatment patterns in each cohort	1 year
Secondary	the referral behavior in county	To describe the referral behavior in county (Among all patients)	1 year
Secondary	he relationship between recurrent risk and OFS, chemotherapy and OFS	To explore the relationship between recurrent risk and OFS, chemotherapy and OFS	1 year
Secondary	the duration of medical OFS in early breast cancer	To explore the duration of medical OFS in early breast cancer	1 year
Secondary	the duration of anti-HER2 therapy in advanced breast cancer	To explore the duration of anti-HER2 therapy in advanced breast cancer	1 year