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Updated: Jan 15, 2026

Building Up a High-throughput Screening Platform to Assess the Heterogeneity of HER2 Gene Amplification in Breast Cancers

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Proliferation-Guided Risk Stratification in HER2-Low versus HER2-Positive Hormone Receptor-Positive Breast Cancer: A

Sait Kitapli¹, Özgür Tanriverdi², İsmail Bayrakci³

¹Department of Medical Oncology, Mugla Sitki Kocman University Faculty of Medicine, Mugla, Turkey.

Oncology Research and Treatment

|January 13, 2026

Summary

Ki67 is a key prognostic biomarker in hormone receptor-positive (HR+) breast cancer, regardless of HER2 status. Dual assessment of HER2 and Ki67 can refine risk stratification and identify patients needing intensified treatment beyond endocrine therapy.

Keywords:

Breast cancer HER2-low breast cancer Hormone receptor-positive disease Ki67 Prognosis Proliferation Survival Targeted therapy

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Published on: December 5, 2017

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Optimization of a Multiplex RNA-based Expression Assay Using Breast Cancer Archival Material

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Published on: August 1, 2018

Area of Science:

Oncology
Cancer Research
Biomarkers

Background:

HER2-low breast cancer represents a distinct subgroup with uncertain prognosis.
Investigating the prognostic value of Ki67 in hormone receptor-positive (HR+) HER2-low and HER2-positive breast cancer is crucial.

Purpose of the Study:

To evaluate the prognostic significance of Ki67 in HR+ HER2-low and HER2-positive breast cancer.
To determine if combined HER2 and Ki67 status improves risk stratification.

Main Methods:

Retrospective analysis of 224 HR+ breast cancer patients across four centers.
Stratification by disease stage (I-III vs. IV) and assessment of survival outcomes (DFS, OS) based on HER2 and Ki67 status.
Kaplan-Meier analysis and Cox regression were employed for survival assessment.

Main Results:

HER2-low patients had longer disease-free survival (DFS) in Stage I-III disease (86 vs. 59 months).
High Ki67 (≥20%) was an independent predictor of poor DFS in Stage I-III and poor overall survival (OS) in Stage IV.
In Stage IV, OS did not differ by HER2 status but was significantly shorter with high Ki67 (18 vs. 29 months).

Conclusions:

Ki67 is a significant prognostic biomarker in HR+ breast cancer, irrespective of HER2 status.
Dual stratification by HER2 and Ki67 status may enhance risk assessment.
Identifying high-risk patients who may benefit from intensified therapies beyond endocrine therapy is possible.