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

Last updated: September 18, 2025
Sponsor: AstraZeneca
Overall Status: Completed

Phase

N/A

Condition

Carcinoma

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT06125314
D133FR00197
  • Female

Study Summary

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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • women ≥ 18 years of age at date of diagnosis

  • Patients must have a histological or cytological confirmed diagnosis of Unresectableor/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 themedical 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 systemicanticancer therapy (e.g., ET, chemotherapy, CDK4/6i, targeted therapies other thananti- HER2, or immunotherapy) in the metastatic setting.

  • Patients must have historical HER2 fixed tissue IHC stained slides in acceptablequality to allow retesting of HER2 expression only in case of the absence ofaccurate scoring of IHC/ISH in pathology report.

Exclusion

Exclusion Criteria:

  • Have a history of other malignancies other than basal cell carcinoma of the skin andsquamous cell carcinoma of the skin.

  • Patients who are HER2 positive (with historical HER2 status of IHC 2+/ISH+ or 3+, orHER2 amplified.

Study Design

Total Participants: 517
Study Start date:
March 05, 2024
Estimated Completion Date:
September 30, 2024

Connect with a study center

  • Research Site

    Kuwait,
    Kuwait

    Site Not Available

  • Research Site

    Kuwait City 285787,
    Kuwait

    Site Not Available

  • Research Site

    Doha,
    Qatar

    Site Not Available

  • Research Site

    Doha 290030,
    Qatar

    Site Not Available

  • Research Site

    Makkah al Mukarramah 104515, Saudi Arabia
    Saudi Arabia

    Site Not Available

  • Research Site

    Makkah,
    Saudi Arabia

    Site Not Available

  • Research Site

    Mecca,
    Saudi Arabia

    Site Not Available

  • Research Site

    Riyadh,
    Saudi Arabia

    Site Not Available

  • Research Site

    Riyadh 108410,
    Saudi Arabia

    Site Not Available

  • Research Site

    Abu Dhabi,
    United Arab Emirates

    Site Not Available

  • Research Site

    Abu Dhabi 292968,
    United Arab Emirates

    Site Not Available

  • Research Site

    Al Ain,
    United Arab Emirates

    Site Not Available

  • Research Site

    Al Ain City 292913,
    United Arab Emirates

    Site Not Available

  • Research Site

    Dubai,
    United Arab Emirates

    Site Not Available

  • Research Site

    Dubai 292223,
    United Arab Emirates

    Site Not Available

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