Completed

NCT Number: NCT06433804

Clinicopathological Parameters of HER2 Low Breast Cancers

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.

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Key information

Conditions

HER2 Low Breast Cancers

Sex eligibility

Female

Study type

Observational

Primary location

VMMC SJH

New Delhi, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Benign breast tumors

Treatment and study plan

HER2 IHC

Diagnostic Test

Immunohistochemistry for HER2

Primary outcomes

Age (in years)

Time frame: JANUARY 2022- DECEMBER 2023

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
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.
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.
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

Sponsors and collaborators

Lead sponsor

Vardhman Mahavir Medical College And Safdarjung Hospital

Other

Registry information

Official study title

Exploring the Clinicopathological Parameters of HER2 Low Breast Cancers

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2024
First posted: May 30, 2024
Registry last updated: May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.