HER2 TREAT Study: Retrospective Study to Estimate the Prevalence of HER2-low in Unresectable and/or Metastatic Breast Cancer Patients Who Progress on Anti-Cancer Therapy Identified as HER2-Negative From Patient Medical Records in The Gulf Cooperation Council

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

517 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-05

Study Completion Date

2024-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

HER2-low Breast cancer (BC) has emerged as a new subtype of BC with distinct clinical, pathological, and prognostic features. Little is known about the prevalence of the HER2-low subtype in HER2-negative patients, and previous reports showed variations in the criteria used to define the HER2-low subtype. Besides, data on the clinical features and prognosis of HER2-low patients are limited, and it is still unclear whether HER2-low BC has a prognostic value. Identifying the prevalence and clinical features of HER2-low BC can help establish a more accurate and reproducible definition of HER2-low BC. In the Gulf Cooperation Council (GCC) region, BC is the most common malignancy in women and still poses a significant burden on healthcare resource utilization, moreover, there is only one record for reimbursed HER2 IHC status, categorized as HER2-positive and HER2-negative. It is important to understand the prevalence, clinical features, and outcomes of HER2-low in BC patients from the GCC In this retrospective, non-interventional, multicenter study, the aim to describe the prevalence of HER2-low BC among the current HER2-negative BC population using rescored HER2 IHC samples. The local treatment patterns and the outcomes will be analyzed using the information abstracted from the corresponding medical chart review. The study will cover the GCC region countries (United Arab Emirates \[UAE\], Saudi Arabia, Qatar, Kuwait, and Oman)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Estimation of the Prevalence of HER2 Low and Describe the SoC, Treatment Patterns, and Outcome in Real-world Practice Among Unresectable and/or Metastatic Breast Cancer Patients With HER2 Low Status

NCT04807595

Breast Cancer

COMPLETED

Long-term Outcome of HER2-amplified Metastatic Breast Cancer: A Retrospective Analysis

NCT02560311

ERBB2 Breast Cancer Metastatic Neoplasm

UNKNOWN

Study of Predictors of Clinical Outcomes in Patients With HR+ and HER2-low/Negative Breast Cancer

NCT06040593

Hormone-receptor-positive Breast Cancer HER2-low Breast Cancer HER2-negative Breast Cancer

COMPLETED

HER2-low Unresectable and/or Metastatic Breast Cancer in Russia

NCT05913440

Breast Cancer

COMPLETED

HER2(Human Epidermal Growth Factor Receptor 2) -Positive Metastatic Breast Cancer in Russia

NCT05905939

Breast Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Neoplasms Breast Cancer Breast Carcinoma Genes HER2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* women ≥ 18 years of age at date of diagnosis
* Patients must have a histological or cytological confirmed diagnosis of Unresectable or/and mBC between 01st January 2018 and 31st December 2022.
* Patients with at least 12 months of follow-up data (from the index date) in the medical records at the participating site unless patient died.
* Patients must have been diagnosed as HER2-negative (HER2 IHC 0, 1+, 2+/ISH-), regardless of hormone status.
* Patients who are diagnosed and/or progressed on at least one prior systemic anticancer therapy (e.g., ET, chemotherapy, CDK4/6i, targeted therapies other than anti- HER2, or immunotherapy) in the metastatic setting.
* Patients must have historical HER2 fixed tissue IHC stained slides in acceptable quality to allow retesting of HER2 expression only in case of the absence of accurate scoring of IHC/ISH in pathology report.

Exclusion Criteria

* Have a history of other malignancies other than basal cell carcinoma of the skin and squamous cell carcinoma of the skin.
* Patients who are HER2 positive (with historical HER2 status of IHC 2+/ISH+ or 3+, or HER2 amplified.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No