NCT05544123

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

September 29, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

10 months

First QC Date

September 9, 2022

Last Update Submit

January 1, 2023

Conditions

Breast CancerBreast CarcinomaBreast Tumor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • the referral behavior in county

    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

  • the duration of anti-HER2 therapy in advanced breast cancer

    1 year

Other Outcomes (3)

  • Proportion of re-biopsy of recurrent/metastatic disease

    1 year

  • Rate of HER2 testing in county

    1 year

  • Percentage of Her-2 low expression among HR+HER2- early and advanced breast cancer (Cohort 2 and Cohort 4)

    1 year

Study Arms (4)

Cohort 1 HER2+ EBC

newly diagnosed or completed definitive breast surgery

Other: pathological stage

Cohort 2 HR+ HER2- EBC

newly diagnosed or completed definitive breast surgery

Other: pathological stage

Cohort 3 HER2+ ABC

De novo or relapsed from adjuvant therapy

Other: pathological stage

Cohort 4 HR+ HER2- ABC

De novo or relapsed from adjuvant therapy

Other: pathological stage

Interventions

pathological stageOTHER

breast cancer molecular subtyping and pathological TNM stage

Cohort 1 HER2+ EBCCohort 2 HR+ HER2- EBCCohort 3 HER2+ ABCCohort 4 HR+ HER2- ABC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • 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
  • +5 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453100, China

NOT YET RECRUITING

路平

Xinxiang, Henan, 453100, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 16, 2022

Study Start

September 29, 2022

Primary Completion

August 1, 2023

Study Completion

September 1, 2024

Last Updated

January 4, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)