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CompletedNCT05510037Updated Aug 22, 2022

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

An observational study in Breast Cancer, sponsored by Fudan University. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2022-08-22.

Sponsored by Fudan University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,299
Sex
All
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Study 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.

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Conditions studied

  • Breast Cancer

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In context

Breast Neoplasms

12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's enrollment of 1,299 is above the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.

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Lead sponsor

Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Patients with other malignancy

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,299 participants (actual)
Patient registry
No

Groups and cohorts

  • HER2-0

    Other: no intervention

  • HER2-LOW

    Other: no intervention

  • HER2-POSITIVE

    Other: no intervention

Interventions

  • Otherno intervention

    no intervention was needed

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What researchers measure

Primary outcomes

  1. 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

    Time frame: up to 200 months

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Study locations

1 site
  • Fudan University Shanghai Cancer Center
    Shanghai, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05510037
Lead sponsor
Fudan University
Responsible party
Jian Zhang,MD (Director of the phase I clinical trial department, Fudan University) — Principal investigator
First posted
Aug 22, 2022
Start date
Jan 1, 2021
Primary completion
Jun 1, 2022
Completion
Jun 1, 2022
Last update
Aug 22, 2022

Study contacts

Jian Zhang, PHD
principal investigator · Fudan University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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