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Clinicopathological Parameters of HER2 Low Breast Cancers

Exploring the Clinicopathological Parameters of HER2 Low Breast Cancers

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06433804
Enrollment
70
Registered
2024-05-30
Start date
2022-01-01
Completion date
2024-02-01
Last updated
2024-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2 Low Breast Cancers

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.

Interventions

DIAGNOSTIC_TESTHER2 IHC

Immunohistochemistry for HER2

Sponsors

Vardhman Mahavir Medical College And Safdarjung Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Benign breast tumors

Design outcomes

Primary

MeasureTime frameDescription
Age (in years)JANUARY 2022- DECEMBER 2023It will be measured for HER2 low breast cancer patients
Tumor stage (categorised from T1-T4)JANUARY 2022- DECEMBER 2023This 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)JANUARY 2022- DECEMBER 2023This 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)JANUARY 2022- DECEMBER 2023This 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)JANUARY 2022- DECEMBER 2023This denoted the molecular classification of breast cancer based on ER, PR, Her2 expression.
Androgen receptor expression (Denoted as present or absent)JANUARY 2022- DECEMBER 2023This denoted the immunohistochemical expression of androgen receptor which would be evaluted in all cases of HER2 low breast cancer

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026