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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05510037

Enrollment

1299

Registered

2022-08-22

Start date

2021-01-01

Completion date

2022-06-01

Last updated

2022-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief 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.

Interventions

OTHERno intervention

no intervention was needed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

Patients with available HER2 status of primary breast cancer and relapse/metastases

Exclusion criteria

Patients with other malignancy

Design outcomes

Primary

Measure	Time frame	Description
overall survival	up to 200 months	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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026