News - HER-2 mutation

HEROS: Observational, Prospective, Multi-centric Study Exploring HER2 Mutations Incidence and Therapeutic Management in aNSCLC (clinicaltrials.gov)

P=N/A, N=50, Recruiting, Gruppo Oncologico Italiano di Ricerca Clinica | Trial primary completion date: Jan 2026 --> Jan 2027

1 day ago

Trial primary completion date

HER-2 (Human epidermal growth factor receptor 2)

HER-2 mutation

Beamion PANTUMOR-1: rationale and design of a Phase II trial of zongertinib in HER2-overexpressed/amplified or HER2-mutant solid tumors. (PubMed, Future Oncol)

Secondary endpoints include duration of response, progression-free survival, disease control, occurrence of treatment-emergent adverse events, and health-related quality of life. Recruitment is ongoing in 13 countries globally.Clinical trial registration http://www.clinicaltrials.gov identifier is NCT06581432.

3 days ago

P2 data • Journal • Pan tumor

HER-2 (Human epidermal growth factor receptor 2)

HER-2 positive • HER-2 overexpression • HER-2 amplification • HER-2 mutation • EGFR wild-type • HER-2 positive + HER-2 overexpression

Hernexeos (zongertinib)

Breast Cancer Drug Resistance: Precision Targeting of ER and HER2 Signalling Networks. (PubMed, Curr Pharm Des)

In conclusion, this review provides critical insights into the intricate mechanisms of drug resistance in BC, underscoring the pivotal roles of the ER and HER2 signaling pathways. It identifies unique resistance mechanisms and potential therapeutic targets, paving the way for the development of advanced strategies to improve treatment outcomes.

6 days ago

Journal

HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)

HER-2 mutation

Whole Body HER2 Quantification With 89Zr-Trastuzumab PET/CT to Asses Zr-trastuzumab Accumulation in HER2-mutated and HER2-overexpressing Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)

P1, N=20, Not yet recruiting, The Netherlands Cancer Institute

7 days ago

New P1 trial

HER-2 (Human epidermal growth factor receptor 2)

HER-2 overexpression • HER-2 mutation

Herceptin (trastuzumab)

Retrospective Comparison of Operational Metrics Across Diagnostic Approaches for Molecular Testing in Lung and Colon Cancers in a Community-Based Setting. (PubMed, Arch Pathol Lab Med)

OFA balances TAT, QNS, and detection, whereas SO-NGS offers comprehensive detection with longer TAT and higher QNS. An optimized assay combining SGP's speed, OFA's reliability, and SO-NGS's comprehensiveness could improve outcomes.

7 days ago

Retrospective data • Journal

EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MSI (Microsatellite instability) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • TYK2 (Tyrosine Kinase 2) • NTRK (Neurotrophic receptor tyrosine kinase)

KRAS G12C • HER-2 amplification • HER-2 mutation • MET exon 14 mutation • KRAS G12 • KRAS amplification • NRAS G12

Oncomine Focus Assay

Integrated Molecular Profiling of Colorectal Cancer by Tumor Location: Evidence from a Real-World Cohort with Primary and Metastatic Samples. (PubMed, Cancers (Basel))

Tumor location in CRC correlates with distinct molecular patterns. Right-sided tumors are associated with dMMR, MSI-H, and higher TMB, while left-sided CRCs display more ERBB2 alterations and class 5 APC mutations. The results highlight the importance of integrating tumor location into personalized molecular diagnostics and therapeutic planning for CRC patients.

8 days ago

Journal • Real-world evidence • Tumor mutational burden • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker

HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • APC (APC Regulator Of WNT Signaling Pathway)

PD-L1 expression • TP53 mutation • KRAS mutation • TMB-H • MSI-H/dMMR • HER-2 overexpression • BRAF mutation • HER-2 mutation

Tumor genomics in patients younger than 40 years of age with metastatic breast cancer. (PubMed, NPJ Precis Oncol)

OS was shorter among younger recurrent MBC patients [median: 2.8 (≤ 40) vs. 3.6 years ( > 55), p = 0.04], with SNVs in TP53 and PTEN associated with shorter OS. Distinct tumor genomics of young-onset MBC patients suggest differences in tumor biology that should guide investigation of targetable pathways.

8 days ago

Journal

HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • CDH1 (Cadherin 1)

TP53 mutation • HER-2 amplification • PIK3CA mutation • HER-2 mutation

Systemic and Intracranial Efficacy and Safety of Trastuzumab Deruxtecan in Patients with HER2-Mutant Non-Small Cell Lung Cancer across Treatment Lines: Evidence from the TRACER/HERTras Real-World Cohort. (PubMed, J Thorac Oncol)

In the largest real-world cohort reported to date, T-DXd demonstrated robust systemic and intracranial activity in HER2-mutant NSCLC, including treatment-naïve patients and those with active brain metastases who were largely excluded from prior studies. Toxicity was consistent with previous reports, with ILD remaining the main safety concern. These findings support integration of HER2-targeted therapies into evolving treatment algorithms.

8 days ago

Journal • Real-world evidence

HER-2 (Human epidermal growth factor receptor 2)

HER-2 mutation

Enhertu (fam-trastuzumab deruxtecan-nxki)

Enhancing Clinical Trial Selection for Cancer Patients Using Large Language Models. (PubMed, Cancer Inform)

Furthermore, decision trees provided interpretability by identifying key textual indicators that LLMs use. This work demonstrates the feasibility of using proprietary LLMs such as GPT 4.0 and Gemini 2.0 "off the shelf" with both limited LLM fine-tuning and limited patient information to evaluate clinical trial eligibility.

9 days ago

Journal

EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase)

KRAS mutation • EGFR mutation • BRAF mutation • HER-2 mutation • KIT mutation

11d

A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations (clinicaltrials.gov)

P1, N=134, Active, not recruiting, Atavistik Bio, Inc | Recruiting --> Active, not recruiting

11 days ago

Enrollment closed • First-in-human

HER-2 (Human epidermal growth factor receptor 2) • AKT1 (V-akt murine thymoma viral oncogene homolog 1)

HER-2 negative • HER-2 mutation • AKT1 mutation

fulvestrant

11d

A Study of Trastuzumab Deruxtecan in People With Non-Small Cell Lung Cancer (clinicaltrials.gov)

P2, N=14, Recruiting, Memorial Sloan Kettering Cancer Center

11 days ago

New P2 trial

HER-2 (Human epidermal growth factor receptor 2)

HER-2 amplification • HER-2 mutation

Enhertu (fam-trastuzumab deruxtecan-nxki) • Ogivri (trastuzumab-dkst)

16d

Permissive Cardiotoxicity in HER2-Positive Metastatic Breast Cancer With Moderate Left Ventricular Dysfunction. (PubMed, JACC Case Rep)

Optimal GDMT supports cardiac recovery in patients with asymptomatic left ventricular dysfunction, allowing for continued HER2 therapy. Integrated cardio-oncology care is essential to balance cancer control with cardiovascular safety.

16 days ago

Journal

HER-2 (Human epidermal growth factor receptor 2)

HER-2 positive • HER-2 mutation • EGFR positive

Herceptin (trastuzumab) • Perjeta (pertuzumab)