Tumor Characteristics and Survival Rate of HER2-Low Breast Cancer Patients

Sponsor

Mahdis Bayat (Other)

Overall Status

Completed

CT.gov ID

NCT05754047

Collaborator

(none)

3,582

Enrollment

371

Actual Duration (Months)

Study Details

Study Description

Brief Summary

In this large-scale cross-sectional study, we evaluated disease-free survival (DFS), overall survival (OS), and clinicopathological characteristics of BC patients from 1991 to 2022, retrospectively. We recruited patients referred to the Cancer Research Center in Tehran, Iran, and their HER2 status, which is classified as HER2-low, HER2-positive, or HER2-negative, was obtained from prospectively maintained registries. we aimed to dive more deeply into the clinicopathological characteristics and survival features of HER2-low breast cancer patients and campared it with HER2-negative and HER2-positive groups.

Question 1: Is HER2-low breast cancer (BC) a new subtype in the standard classification of BCs? Question 2: How is the DFS and OS rate of HER2-low breast cancer patients in comparison with HER2-negative and HER2-positive groups?

Condition or Disease	Intervention/Treatment	Phase
HER2 Low Breast Carcinoma	Diagnostic Test: immunohistochemistry (IHC) and in situ hybridization (ISH) Test

Study Design

Study Type:

Observational

Actual Enrollment :

3582 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Tumor Characteristics and Survival Rate of HER2-Low Breast Cancer Patients; a Cross-Sectional Study

Actual Study Start Date :

Apr 1, 1991

Actual Primary Completion Date :

Mar 1, 2022

Actual Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
HER2-low patients with HER2 IHC1+ and HER2 IHC2+/ISH-negative in their pathology	Diagnostic Test: immunohistochemistry (IHC) and in situ hybridization (ISH) Test These tests are usually applied for breast cancer patients to assist the surgeon to better understand the clinicopathological characteristics and survival features of tumors
HER2-negative patients with HER2-zero in their pathology	Diagnostic Test: immunohistochemistry (IHC) and in situ hybridization (ISH) Test These tests are usually applied for breast cancer patients to assist the surgeon to better understand the clinicopathological characteristics and survival features of tumors
HER2-positive patients with HER2 IHC2+/ISH-positive and HER2 IHC 3+ in their pathology	Diagnostic Test: immunohistochemistry (IHC) and in situ hybridization (ISH) Test These tests are usually applied for breast cancer patients to assist the surgeon to better understand the clinicopathological characteristics and survival features of tumors

Arm

Intervention/Treatment

HER2-low

patients with HER2 IHC1+ and HER2 IHC2+/ISH-negative in their pathology

Diagnostic Test: immunohistochemistry (IHC) and in situ hybridization (ISH) Test

These tests are usually applied for breast cancer patients to assist the surgeon to better understand the clinicopathological characteristics and survival features of tumors

HER2-negative

patients with HER2-zero in their pathology

Diagnostic Test: immunohistochemistry (IHC) and in situ hybridization (ISH) Test

These tests are usually applied for breast cancer patients to assist the surgeon to better understand the clinicopathological characteristics and survival features of tumors

HER2-positive

patients with HER2 IHC2+/ISH-positive and HER2 IHC 3+ in their pathology

Diagnostic Test: immunohistochemistry (IHC) and in situ hybridization (ISH) Test

These tests are usually applied for breast cancer patients to assist the surgeon to better understand the clinicopathological characteristics and survival features of tumors

Outcome Measures

Primary Outcome Measures

HER2-low OS [38 months]
HER2-low status had the highest survival rate.
HER2-low DFS [33 months]
HER2-low status had the highest DFS.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

All breast cancer patients with human epidermal growth factor receptor 2 (HER2) status in the database of the Cancer Research Center (CRC),from April 1991 to March 2022

Exclusion Criteria:

The male gender Patients with indeterminate or missing HER2 status, or patients with missing DFS and OS information

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mahdis Bayat

Investigators

Study Director: Mohammad Esmail Akbari, Professor, Cancer Research Center, Shohadaye Tajrish Hospital, Shahid Beheshti University of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mahdis Bayat, Doctor, Shahid Beheshti University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT05754047

Other Study ID Numbers:

MBAYAT

First Posted:

Mar 3, 2023

Last Update Posted:

Mar 3, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mahdis Bayat, Doctor, Shahid Beheshti University of Medical Sciences

Breast cancer, ErbB-2, HER2-low, Disease-Free Survival, Survival Rate

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Mar 3, 2023