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NCT05510037 Clinical Trial

Incidence and Prognostic Significance of HER-2 Status Discordance Between Primary Breast Cancer and Paired Recurrent/Metastatic Lesions

Breast Cancer Clinical Trial

Official title:
Incidence and Prognostic Significance of HER-2 Status Discordance Between Primary Breast Cancer and Paired Recurrent/Metastatic Lesions

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05510037
Other study ID # YBCSG-22-08
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date June 1, 2022

Study information
Verified date August 2022
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

About a half of HER2-negative breast cancer show HER2-low expression that can be targeted by new antibody-drug conjugates. The main aim of this study is to describe the evolution of HER2 expression from primary BC to relapse by including HER2-low category in both primary and recurrent BC samples. Patients with matched primary and relapse BC samples were included. 1299 patients were included.

Recruitment information / eligibility
Status Completed
Enrollment 1299
Est. completion date June 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Patients with available HER2 status of primary breast cancer and relapse/metastases Exclusion Criteria: Patients with other malignancy

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• no intervention
no intervention was needed

Locations
Country Name City State
China Fudan University Shanghai Cancer Center Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary overall survival The overall survival (OS) was defined as time from the date of initial diagnosis of recurrent/metastatic disease to the date of death from any cause up to 200 months
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