HER-2 amplification

P1, N=27, Active, not recruiting, Institut Paoli-Calmettes | Recruiting --> Active, not recruiting

T. gondii infection is highly prevalent in female patients with breast tumors and is correlated with specific environmental exposures and clinicopathologic features of tumor invasiveness. This robust predictive model can be used accurately and reliably for individualized risk assessment of T. gondii infection in women with breast tumors. It can assist clinicians in developing targeted screening and intervention plans, maximizing clinical benefits while reducing unnecessary diagnostic and treatment procedures.

P2, N=50, Recruiting, Yale University | Trial completion date: Jul 2028 --> Dec 2028 | Trial primary completion date: Jul 2026 --> Dec 2026

This guidebook reviews the current guidelines for HER2 testing and reporting in carcinomas of different organ systems. In addition, it discusses the challenges of designing a unified biomarker reporting format to cover alternative scoring systems.

Multiplexed imaging showed broad but heterogeneous HER2 expression across tumor states in both cases; in the MYCN-amplified tumor, this occurred alongside EGFR/MAPK-enriched proliferative niches, whereas the ZFTA-RELA tumor showed more diffuse organization without strong coupling of EGFR and proliferation. These findings provide early clinical evidence supporting HER2-directed ADCs in ependymoma and highlight the value of integrated molecular and spatial profiling in interpreting therapeutic response in rare CNS tumors.

The temporal relationship between molecular and radiologic findings observed here suggests potential value for earlier detection of disease activity, although whether such lead time translates into improved clinical outcomes requires prospective validation. The findings support prospective evaluation of this approach, including the ongoing TROPHY trial investigating this therapeutic approach.

P1, N=28, Suspended, H. Lee Moffitt Cancer Center and Research Institute | Recruiting --> Suspended | Trial primary completion date: Apr 2026 --> Aug 2026

ADCs against TROP2 (Sacituzumab govitecan) or HER2 (T-DXd) have demonstrated efficacy in metastatic breast cancer, yet paradoxically, outside of HER2-amplified breast cancers, expression levels of these breast cancer-enriched epitopes in tumor biopsies have not been strongly correlated with clinical response. Thus, while CTC burden is correlated with response to these ADCs, the level of TROP2 or HER2 expression is poorly predictive. These findings point to sensitivity to the drug payload as a potential driver of clinical response to currently approved ADCs in breast cancer.

P2, N=63, Completed, City of Hope Medical Center | Active, not recruiting --> Completed

P2, N=124, Recruiting, The First Affiliated Hospital of Soochow University

Complex relationships between ERBB2 alterations and HER2 IHC expression exist, including increased expression in non-ERBB2-amplified tumors with pathogenic mutations. Importantly, ERBB2/HER2 amplification and/or mutation rates as well as transcript and protein expression varied between cancers and within cancer types, emphasizing the need for individual assessment.

P2, N=8, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Recruiting --> Active, not recruiting | N=36 --> 8