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Clinical Trials/NCT06433804
NCT06433804
Completed
Not Applicable

Exploring the Clinicopathological Parameters of HER2 Low Breast Cancers

Vardhman Mahavir Medical College And Safdarjung Hospital1 site in 1 country70 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HER2 Low Breast Cancers
Sponsor
Vardhman Mahavir Medical College And Safdarjung Hospital
Enrollment
70
Locations
1
Primary Endpoint
Age (in years)
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
February 1, 2024
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
Vardhman Mahavir Medical College And Safdarjung Hospital
Responsible Party
Principal Investigator
Principal Investigator

SANA AHUJA

ASSISTANT PROFESSOR

Vardhman Mahavir Medical College And Safdarjung Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Benign breast tumors

Outcomes

Primary Outcomes

Age (in years)

Time Frame: JANUARY 2022- DECEMBER 2023

It will be measured for HER2 low breast cancer patients

Tumor grade (categorised from G1-G3)

Time Frame: JANUARY 2022- DECEMBER 2023

This denotes whether tumor is well, modeartely or porrly differentiated. It will be measured for HER2 low breast cancer patients.

Tumor stage (categorised from T1-T4)

Time Frame: JANUARY 2022- DECEMBER 2023

This denotes status of stage of tumor- T1, T2, T3, T4. It will be measured for HER2 low breast cancer patients

N stage (categorised from N0-N3)

Time Frame: JANUARY 2022- DECEMBER 2023

This denotes status of nodal involevement- N0, N1, N2 or N3. It will be measured for HER2 low breast cancer patients

Androgen receptor expression (Denoted as present or absent)

Time Frame: JANUARY 2022- DECEMBER 2023

This denoted the immunohistochemical expression of androgen receptor which would be evaluted in all cases of HER2 low breast cancer

Surrogate molecular classification (Categorised as luminal/ triple negative)

Time Frame: JANUARY 2022- DECEMBER 2023

This denoted the molecular classification of breast cancer based on ER, PR, Her2 expression.

Study Sites (1)

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