The Treatment Situation of Chinese County Population With Breast Cancer

January 1, 2023 updated by: The First Affiliated Hospital of Xinxiang Medical College

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Observational

Enrollment (Anticipated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Xinxiang, Henan, China, 453100
        • Not yet recruiting
        • The First Affiliated Hospital of Xinxiang Medical University
        • Contact:
        • Contact:
      • Xinxiang, Henan, China, 453100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1 HER2+ EBC
newly diagnosed or completed definitive breast surgery
Other: pathological stage
breast cancer molecular subtyping and pathological TNM stage
Cohort 2 HR+ HER2- EBC
newly diagnosed or completed definitive breast surgery
Other: pathological stage
breast cancer molecular subtyping and pathological TNM stage
Cohort 3 HER2+ ABC
De novo or relapsed from adjuvant therapy
Other: pathological stage
breast cancer molecular subtyping and pathological TNM stage
Cohort 4 HR+ HER2- ABC
De novo or relapsed from adjuvant therapy
Other: pathological stage
breast cancer molecular subtyping and pathological TNM stage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the treatment pattern in HER2+, and HR+HER2- early and advanced breast cancer patients in county in each cohort
Time Frame: 1 year
Different treatment patterns in each cohort
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the referral behavior in county
Time Frame: 1 year
To describe the referral behavior in county (Among all patients)
1 year
he relationship between recurrent risk and OFS, chemotherapy and OFS
Time Frame: 1 year
To explore the relationship between recurrent risk and OFS, chemotherapy and OFS
1 year
the duration of medical OFS in early breast cancer
Time Frame: 1 year
To explore the duration of medical OFS in early breast cancer
1 year
the duration of anti-HER2 therapy in advanced breast cancer
Time Frame: 1 year
To explore the duration of anti-HER2 therapy in advanced breast cancer
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of re-biopsy of recurrent/metastatic disease
Time Frame: 1 year
Proportion of re-biopsy of recurrent/metastatic disease
1 year
Rate of HER2 testing in county
Time Frame: 1 year
Rate of HER2 testing in county (IHC and FISH) (Among all patients)
1 year
Percentage of Her-2 low expression among HR+HER2- early and advanced breast cancer (Cohort 2 and Cohort 4)
Time Frame: 1 year
Percentage of Her-2 low expression among HR+HER2- early and advanced breast cancer (Cohort 2 and Cohort 4)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Xinxiang Medical College

Collaborators

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2022

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

September 9, 2022

First Submitted That Met QC Criteria

September 13, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 1, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESR-21-21505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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