Clinicopathological Parameters of HER2 Low Breast Cancers
- Conditions
- HER2 Low Breast Cancers
- Interventions
- Diagnostic Test: HER2 IHC
- Registration Number
- NCT06433804
- Lead Sponsor
- Vardhman Mahavir Medical College And Safdarjung Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 70
- All histologically proven cases of breast cancer in the 2 years from January 2022- December 2023
- Benign breast tumors
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HER2 negative HER2 IHC - HER2 low HER2 IHC -
- Primary Outcome Measures
Name Time Method Tumor grade (categorised from G1-G3) JANUARY 2022- DECEMBER 2023 This denotes whether tumor is well, modeartely or porrly differentiated. It will be measured for HER2 low breast cancer patients.
Age (in years) JANUARY 2022- DECEMBER 2023 It will be measured for HER2 low breast cancer patients
Tumor stage (categorised from T1-T4) 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) 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) 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) JANUARY 2022- DECEMBER 2023 This denoted the molecular classification of breast cancer based on ER, PR, Her2 expression.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
VMMC SJH
🇮🇳New Delhi, India