Clinical trial NCT05544123: The Treatment Situation of Chinese County Population With Breast Cancer
Official title: A Multi-center, Observational Study to Describe the Treatment Situation of Chinese County Population With HER2+ & HR+/HER2- Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Breast Carcinoma
Breast Tumor
Lead sponsor: The First Affiliated Hospital of Xinxiang Medical College
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2022-09-16
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 2500 breast cancer patients will be recruited in this study. The entire subjects are spread over 13 Provinces (Henan province, Hebei province, Hunan Province etc.) and 2 autonomous regions (Inner Mongolia Autonomous Region and Guangxi Zhuang Autonomous Region). In order to acquire adequate treatment patterns choices in China county area. Data collection and analysis are needed in the corresponding population.

Data collection and analysis are needed in the corresponding population. The entire subjects contain in this study are spread over 13 Provinces (Henan province, Hebei province, Hunan Province etc.) and 2 autonomous regions (Inner Mongolia Autonomous Region and Guangxi Zhuang Autonomous Region).

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.

Eligibility criteria: 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

Primary outcomes:
measure: the treatment pattern in HER2+, and HR+HER2- early and advanced breast cancer patients in county in each cohort
timeFrame: 1 year
Secondary outcomes:
measure: the referral behavior in county
timeFrame: 1 year
measure: he relationship between recurrent risk and OFS, chemotherapy and OFS
timeFrame: 1 year
measure: the duration of medical OFS in early breast cancer
timeFrame: 1 year
measure: the duration of anti-HER2 therapy in advanced breast cancer
timeFrame: 1 year
Other outcomes:
measure: Proportion of re-biopsy of recurrent/metastatic disease
timeFrame: 1 year
measure: Rate of HER2 testing in county
timeFrame: 1 year
measure: Percentage of Her-2 low expression among HR+HER2- early and advanced breast cancer (Cohort 2 and Cohort 4)
timeFrame: 1 year
Locations:
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Xinxiang
country: China
facility: 路平
state: Henan
Study officials:
References: