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

NCT ID: NCT05510037

Last Updated: 2022-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1299 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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HER2-0

no intervention

Intervention Type OTHER

no intervention was needed

HER2-LOW

no intervention

Intervention Type OTHER

no intervention was needed

HER2-POSITIVE

no intervention

Intervention Type OTHER

no intervention was needed

Interventions

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no intervention

no intervention was needed

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Patients with other malignancy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Jian Zhang,MD

Director of the phase I clinical trial department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jian Zhang, PHD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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YBCSG-22-08

Identifier Type: -

Identifier Source: org_study_id

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