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

March 2, 2023 updated by: Mahdis Bayat

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3582

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

There were 3918 patients with human epidermal growth factor receptor 2 (HER2) status in the database of the Cancer Research Center (CRC), among which, 24 male patients and 312 patients with missing DFS and OS information were excluded. In total, 3582 patients have been included in DFS and OS analysis.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HER2-low OS
Time Frame: 38 months
HER2-low status had the highest survival rate.
38 months
HER2-low DFS
Time Frame: 33 months
HER2-low status had the highest DFS.
33 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahdis Bayat

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 1991

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Estimate)

March 3, 2023

Study Record Updates

Last Update Posted (Estimate)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBAYAT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available upon a reasonable request. Due to the sensitive nature of the clinical data collected in this study, patients were assured raw data would remain confidential and would not be shared except under specific requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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