Clinicopathological Parameters of HER2 Low Breast Cancers

May 29, 2024 updated by: SANA AHUJA, Vardhman Mahavir Medical College And Safdarjung Hospital

Exploring the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • New Delhi, India
        • VMMC SJH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Benign breast tumors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HER2 low
Diagnostic test: HER2 IHC
Immunohistochemistry for HER2
HER2 negative
Diagnostic test: HER2 IHC
Immunohistochemistry for HER2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age (in years)
Time Frame: JANUARY 2022- DECEMBER 2023
It will be measured for HER2 low breast cancer patients
JANUARY 2022- DECEMBER 2023
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
JANUARY 2022- DECEMBER 2023
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
JANUARY 2022- DECEMBER 2023
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.
JANUARY 2022- DECEMBER 2023
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.
JANUARY 2022- DECEMBER 2023
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
JANUARY 2022- DECEMBER 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vardhman Mahavir Medical College And Safdarjung Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Actual)

May 30, 2024

Last Update Submitted That Met QC Criteria

May 29, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-229

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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