NCT05754047

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?

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,582

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 1991

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1991

Completed
30.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 3, 2023

Completed
Last Updated

March 3, 2023

Status Verified

March 1, 2023

Enrollment Period

30.9 years

First QC Date

February 22, 2023

Last Update Submit

March 2, 2023

Conditions

HER2 Low Breast Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (2)

  • HER2-low OS

    HER2-low status had the highest survival rate.

    38 months

  • HER2-low DFS

    HER2-low status had the highest DFS.

    33 months

Study Arms (3)

HER2-low

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

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

HER2-negative

patients with HER2-zero in their pathology

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

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

Interventions

immunohistochemistry (IHC) and in situ hybridization (ISH) TestDIAGNOSTIC_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-lowHER2-negativeHER2-positive

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe patients with male gender were excluded
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Abbasvandi F, Bayat M, Akbari A, Shojaeian F, Zandi A, Rahmani J, Hashemi MO, Akbari ME. Tumor characteristics and survival rate of HER2-low breast cancer patients: a retrospective cohort study. Sci Rep. 2023 Oct 4;13(1):16719. doi: 10.1038/s41598-023-43186-8.

    PMID: 37794050DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ImmunohistochemistryIn Situ Hybridization

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

HistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesImmunologic TechniquesStaining and LabelingHistocytological Preparation TechniquesNucleic Acid HybridizationGenetic Techniques

Study Officials

  • Mohammad Esmail Akbari, Professor

    Cancer Research Center, Shohadaye Tajrish Hospital, Shahid Beheshti University of Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 22, 2023

First Posted

March 3, 2023

Study Start

April 1, 1991

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

March 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

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.