Clinicopathological Parameters of HER2 Low Breast Cancers

NCT ID: NCT06433804

Last Updated: 2024-05-30

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

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-02-01

Brief Summary

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This was a retrospective cohort study which included all histologically proven cases of breast cancer in the 2 years from January 2022- December 2023 at a tertiary care centre.

This study was performed in line with STROCSS criteria. The following clinicopathological data was retrieved from the histopathological records- age, tumor size, nodal involvement, lymphovascular/ perineural invasion, and Bloom Richardson grading.

Routine histopathological processing was done followed by immunohistochemical analysis for ER, PR, HER2, Ki67 and AR. All the cases were categorised into Luminal A, B, Her2 enriched and triple-negative breast cancer based on the surrogate molecular classification. Further, all the cases were categorised into HER2 negative (no staining or incomplete weak membrane staining in ≤10% tumor cells), HER2 3+ (complete membranous staining) and HER2 low (1-2+ staining without amplification on ISH) based on consensus of two pathology consultants. The present study aims to evaluate the clinicopathological parameters of the HER2 low breast cancers.

Detailed Description

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Conditions

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HER2 Low Breast Cancers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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HER2 low

HER2 IHC

Intervention Type DIAGNOSTIC_TEST

Immunohistochemistry for HER2

HER2 negative

HER2 IHC

Intervention Type DIAGNOSTIC_TEST

Immunohistochemistry for HER2

Interventions

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HER2 IHC

Immunohistochemistry for HER2

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* All histologically proven cases of breast cancer in the 2 years from January 2022- December 2023

Exclusion Criteria

* Benign breast tumors
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Vardhman Mahavir Medical College And Safdarjung Hospital

OTHER

Sponsor Role lead

Responsible Party

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SANA AHUJA

ASSISTANT PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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VMMC SJH

New Delhi, , India

Site Status

Countries

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India

Other Identifiers

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CC-229

Identifier Type: -

Identifier Source: org_study_id

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