Clinicopathological Parameters of HER2 Low Breast Cancers

NCT06433804 | Completed

• 1 other identifier: CC-229
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

HER2 Low Breast Cancers

Outcome Measures

Primary Outcomes (6)

• Age (in years)

  It will be measured for HER2 low breast cancer patients

  JANUARY 2022- DECEMBER 2023

• Tumor stage (categorised from T1-T4)

  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)

  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)

  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)

  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)

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

  JANUARY 2022- DECEMBER 2023

Study Arms (2)

HER2 low

Diagnostic Test: HER2 IHC

HER2 negative

Diagnostic Test: HER2 IHC

Interventions

HER2 IHC DIAGNOSTIC_TEST

Immunohistochemistry for HER2

HER2 low; HER2 negative

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Benign breast tumors

Sponsors & Collaborators

• Vardhman Mahavir Medical College And Safdarjung Hospital: lead

Study Sites (1)

VMMC SJH

New Delhi, India

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 30, 2024
• Study Start: January 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)