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Determining the prevalence of HER2-low in metastatic breast cancer patients

Multicentre NIS Retrospective Study to Know the Prevalence of HER2- Low,Clinical Characteristics,Treatment Patterns,Associated Outcome in Patient With HER2-negative in Metastatic Breast Cancer Who Progressed on Systemic Anticancer Therapy

Observational AstraZeneca · NCT06131424

This study looks to see how common HER2-low is in patients with metastatic breast cancer who have already been treated and to understand their treatment experiences and outcomes.

Quick facts

Study typeObservational
Enrollment2700 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy
Locations24 sites (Rosario and 23 other locations)
Trial IDNCT06131424 on ClinicalTrials.gov

What this trial studies

This observational, multicenter, retrospective study aims to estimate the prevalence and characteristics of HER2-low metastatic breast cancer (mBC) by rescoring archived IHC-stained slides from patients previously identified as HER2-negative. The study will analyze data from patients diagnosed between January 2019 and December 2022 who have progressed on systemic anticancer therapies. It will involve extracting sociodemographic and clinical data from medical records, focusing on treatment patterns and clinical outcomes. The study does not involve any specific patient visits or interventions.

Who should consider this trial

Good fit: Ideal candidates include men and women aged 18 and older with a confirmed diagnosis of HER2-negative locally-advanced or metastatic breast cancer who have progressed on systemic anticancer therapy.

Not a fit: Patients who do not have a confirmed diagnosis of HER2-negative breast cancer or those who have not progressed on systemic anticancer therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the prevalence and characteristics of HER2-low mBC, potentially guiding future treatment strategies.

How similar studies have performed: While this study focuses on a specific population with largely unknown prevalence estimates, similar studies have shown success in identifying biomarkers in breast cancer, suggesting potential for meaningful findings.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:1. Men or women, ≥18 years of age 2. Provision of informed consent by the patient or next of kin/legal representative (for deceased patients at study entry, unless a waiver was granted) according to local regulations 3. Must have a histological or cytological confirmed previous diagnosis as HER2-negative (IHC zero, 1+, 2+/ISH-) locally-advanced or mBC between 01 January 2019 and 31 December 2022, regardless of HR status 4. Must have progressed on any systemic anticancer therapy (eg, ET, chemotherapy, CDK4/6 inhibitor, targeted therapies other than anti-HER2, or immunotherapy) in the metastatic setting with the availability of at least 12 months of follow-up data (from the index date) in the medical records at the participating site, unless patient died within the first 12 months of diagnosis a) The HR positive patients will be considered eligible for the study if they have received ET as adjuvant therapy in the early BC setting and progressed within 24 months, this scenario will be considered as progression on systematic treatment in the advanced or metastatic setting 5. Must have historical IHC-stained FFPE tissue from locally-advanced or mBC slides for HER2 in an acceptable quality to allow for accurate rescoring of HER2 expression - Exclusion Criteria:1. Have a history of other malignancies, other than basal cell carcinoma of the skin and squamous cell carcinoma of the skin until 3 years prior to diagnosis of locally-advanced or mBC 2. Patients with historical HER2 status of IHC 2+/ISH+ or 3+, or HER2 amplified

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Where this trial is running

Rosario and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HER2-negativeHER2 Low, Metastatic breast cancerHR:Hormone Receptor, IHC:mmunohistochemistryISH: in situ hybridizationAnticancer therapyPrognostic and Predictive BiomarkerFormalin-fixed, paraffin-embeddedendocrine therapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.