HER-2 amplification + HR-positive

P1, N=165, Recruiting, Iksuda Therapeutics Ltd. | Trial completion date: Sep 2027 --> Dec 2027 | Trial primary completion date: Sep 2026 --> Dec 2026

Precision diagnostics now encompass next-generation sequencing (NGS)-based comprehensive genomic profiling, enabling identification of actionable alterations such as PIK3CA mutations, HER2 amplification, BRCA1/2 pathogenic variants, and NTRK fusions, each linked to approved therapeutic agents. The purpose of this review is to provide a comprehensive synthesis of current and emerging diagnostic modalities in breast cancer-from population-level screening to individualized molecular profiling-and to examine how integrative, multimodal diagnostic platforms are reshaping clinical decision-making in the era of precision medicine.

This case represents one of the longest reported intervals between initial remission and breast cancer recurrence, highlighting the prolonged biologic potential of dormant ER-positive tumor cells. Clinicians should maintain vigilance for recurrence even decades after treatment, particularly in hormone receptor-positive disease.

Our findings indicate that COL1A2 is associated with reduced chemotherapy sensitivity in HR+/HER2- breast cancer and may serve as a candidate biomarker to guide neoadjuvant taxane selection. This study provides a novel theoretical basis for optimizing neoadjuvant chemotherapy regimens in patients with advanced HR+/HER2- breast cancer.

P=N/A, N=1000, Recruiting, Assistance Publique - Hôpitaux de Paris | Not yet recruiting --> Recruiting

P=N/A, N=854, Recruiting, Institut du Cancer de Montpellier - Val d'Aurelle | Not yet recruiting --> Recruiting

This finding suggests that tasquinimod, an S100A9 inhibitor, could be a viable therapeutic option. Furthermore, the interaction between MMP11 and COL16A1 in stroma-rich regions suggests that cancer-associated fibroblasts may contribute to improved outcomes. Our study underscores the critical role of spatial gene expression analysis in elucidating the tumor microenvironment and its impact on prognosis in patients undergoing E+L treatment, thereby opening new avenues for targeted interventions.

P=N/A, N=1000, Not yet recruiting, Assistance Publique - Hôpitaux de Paris

The DESTINY-Breast04 trial demonstrated notable efficacy of the HER2 antibody-drug conjugate trastuzumab deruxtecan over standard chemotherapy in patients with metastatic breast cancer (MBC) defined as HER2-low...These real-world data help establish the prevalence of HER2-low status and its distinct outcomes. The discrepancy in HER2-low status between the primary tumor and metastatic sites highlights the potential for changes in HER2 expression over time, exploring the interaction between HER2-low breast cancer and the tumor microenvironment and emphasizing the importance of monitoring and reassessing HER2 status at various stages to guide treatment decisions effectively and the need for more quantitative and reproducible HER assays.

P2, N=38, Not yet recruiting, Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center

P=N/A, N=80, Not yet recruiting, West China Hospital of Sichuan University; West China Hospital of Sichuan University

HER2-low tumors demonstrated similar pathological responses and survival outcomes compared to HER2-zero tumors. While a HER2-low status does not appear to define a distinct biological subtype in early BC, it remains a relevant classification for emerging HER2-targeted therapies, needing further investigation in prospective studies.