## Protocol Section
### Identification Module
**NCT ID:** NCT06433804

**Brief Title:** Clinicopathological Parameters of HER2 Low Breast Cancers

**Official Title:** Exploring the Clinicopathological Parameters of HER2 Low Breast Cancers

#### Organization Study ID Info
**ID:** CC-229
#### Organization
**Class:** OTHER
**Full Name:** Vardhman Mahavir Medical College And Safdarjung Hospital
### Status Module
#### Completion Date
**Date:** 2024-02-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-12-01

**Type:** ACTUAL

#### Start Date
**Date:** 2022-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Vardhman Mahavir Medical College And Safdarjung Hospital

#### Responsible Party

**Investigator Affiliation:** Vardhman Mahavir Medical College And Safdarjung Hospital

**Investigator Full Name:** SANA AHUJA

**Investigator Title:** ASSISTANT PROFESSOR

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- HER2 Low Breast Cancers

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 70

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Diagnostic Test: HER2 IHC

**Label:** HER2 low

#### Arm Group 2

**Intervention Names:**

- Diagnostic Test: HER2 IHC

**Label:** HER2 negative

### Interventions

#### Intervention 1

**Arm Group Labels:**

- HER2 low

- HER2 negative

**Description:** Immunohistochemistry for HER2

**Name:** HER2 IHC

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** It will be measured for HER2 low breast cancer patients

**Measure:** Age (in years)

**Time Frame:** JANUARY 2022- DECEMBER 2023

**Description:** This denotes status of stage of tumor- T1, T2, T3, T4. It will be measured for HER2 low breast cancer patients

**Measure:** Tumor stage (categorised from T1-T4)

**Time Frame:** JANUARY 2022- DECEMBER 2023

**Description:** This denotes status of nodal involevement- N0, N1, N2 or N3. It will be measured for HER2 low breast cancer patients

**Measure:** N stage (categorised from N0-N3)

**Time Frame:** JANUARY 2022- DECEMBER 2023

**Description:** This denotes whether tumor is well, modeartely or porrly differentiated. It will be measured for HER2 low breast cancer patients.

**Measure:** Tumor grade (categorised from G1-G3)

**Time Frame:** JANUARY 2022- DECEMBER 2023

**Description:** This denoted the molecular classification of breast cancer based on ER, PR, Her2 expression.

**Measure:** Surrogate molecular classification (Categorised as luminal/ triple negative)

**Time Frame:** JANUARY 2022- DECEMBER 2023

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

**Measure:** Androgen receptor expression (Denoted as present or absent)

**Time Frame:** JANUARY 2022- DECEMBER 2023

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

* Benign breast tumors

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New Delhi

**Country:** India

**Facility:** VMMC SJH

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
