News - HER-2 amplification

20h

LaPemERLA: Phase II Lenvatinib and Pembrolizumab in Endocrine Resistant Breast Cancer With Letrozole (clinicaltrials.gov)

P2, N=40, Recruiting, National Cancer Centre, Singapore | Trial completion date: Dec 2027 --> Dec 2028 | Trial primary completion date: Dec 2025 --> Dec 2026

20 hours ago

Trial completion date • Trial primary completion date

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

ER positive • HER-2 amplification • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive

Keytruda (pembrolizumab) • Lenvima (lenvatinib) • letrozole

The benefit of adjuvant pertuzumab and trastuzumab according to estrogen receptor and HER2 expression: a Sub-analysis of the APHINITY trial. (PubMed, J Natl Cancer Inst)

Pertuzumab numerically improved IDFS in all subgroups, greatest in HER2 FISH-low/ER-positive tumors. These exploratory findings are hypothesis-generating and support prospective validation of biomarker-guided strategies.

3 days ago

Clinical • Journal

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

HER-2 positive • ER positive • HER-2 amplification • HER-2 expression • ER negative

Herceptin (trastuzumab) • Perjeta (pertuzumab)

Molecular heterogeneity of endometrial cancer in the real-world: Biomarker patterns by tumor stage, histology, and molecular subtype. (PubMed, Gynecol Oncol)

The results of this real-world study demonstrate that endometrial cancer is a complex disease, characterized by substantial molecular heterogeneity and varying biomarker distributions across histology, stages, and molecular subtypes. This real-world study supports the integration of comprehensive molecular profiling into routine practice to refine prognostic stratification and guide biomarker-driven therapies.

5 days ago

Journal • Real-world evidence • Tumor mutational burden • MSi-H Biomarker

HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • PTEN (Phosphatase and tensin homolog) • ARID1A (AT-rich interaction domain 1A)

TP53 mutation • TMB-H • MSI-H/dMMR • HER-2 amplification • PIK3CA mutation • HER-2 mutation • PTEN mutation • ARID1A mutation

BrUOG 413: Adjuvant Trastuzumab Deruxtecan (Enhertu) & Nivolumab For Patients Who Are Disease Free After Completion of Trimodality Treatment For HER-2+ Cancers of Esophagus & Gastroesophageal Junction (clinicaltrials.gov)

P2, N=1, Active, not recruiting, Brown University | Trial completion date: Jan 2026 --> May 2026

6 days ago

Trial completion date

HER-2 (Human epidermal growth factor receptor 2)

HER-2 overexpression • HER-2 amplification

Opdivo (nivolumab) • Enhertu (fam-trastuzumab deruxtecan-nxki)

DespaTIL: TIL-Driven De-escalated Chemotherapy in Stage I-II TNBC (clinicaltrials.gov)

P2, N=40, Recruiting, D'Or Institute for Research and Education | Not yet recruiting --> Recruiting | Initiation date: Aug 2025 --> Oct 2025

6 days ago

Enrollment open • Trial initiation date

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

HER-2 amplification • HER-2 negative

Keytruda (pembrolizumab) • carboplatin • doxorubicin hydrochloride • cyclophosphamide

10d

Molecular Profiling across 80,000 Patients with Lung Cancer. (PubMed, J Thorac Oncol)

This is the largest NSCLC dataset analyzed for biomarker distribution across histologies, age, sex and genetic ancestry. This dataset confirms sufficient enough biomarker prevalence across many histological subtypes of NSCLC, providing reassurance that all NSCLC cases should be considered for biomarker workup.

10 days ago

Journal • Tumor mutational burden

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) • TMB (Tumor Mutational Burden) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)

KRAS G12C • HER-2 amplification • MET amplification • ALK rearrangement • TMB-L • ROS1 rearrangement • RET rearrangement • KRAS G12

FoundationOne® CDx

11d

JAZMINE: Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer (clinicaltrials.gov)

P1/2, N=24, Not yet recruiting, MedSIR

11 days ago

New P1/2 trial

HER-2 positive • HER-2 amplification

capecitabine • Halaven (eribulin mesylate) • Tukysa (tucatinib) • Ziihera (zanidatamab-hrii)

11d

Polyploid and Chromosomal Copy Number Gain Cells in Metastatic Colon Cancer: Exploratory Genotype-Phenotype Correlations. (PubMed, Cancers (Basel))

In metastatic colon cancer, the presence of genome-wide copy number gain may delineate a tumor subset with distinctive clinicopathological and molecular characteristics. Further studies are warranted to elucidate the biological significance of these features and to explore their potential implications for tumor evolution, treatment response, and clinical stratification.

11 days ago

Journal

HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • SMAD4 (SMAD family member 4)

TP53 mutation • BRAF mutation • HER-2 amplification • RAS mutation

TruSight Oncology 500 Assay

11d

Molecular Targeting of EGFR, BRAF, and HER2 Signaling in Colorectal Cancer: Contemporary Advances with Panitumumab, Encorafenib, and Tucatinib. (PubMed, J Clin Med)

Trastuzumab-based combinations and HER2-selective tyrosine kinase inhibitors such as tucatinib have demonstrated durable responses and favorable safety profiles in heavily pretreated patients. This review summarizes current evidence from pivotal phase II and III clinical trials, translational studies, and real-world data evaluating EGFR-, BRAF-, and HER2-directed therapies in colorectal cancer. Particular emphasis is placed on biomarker-guided patient selection, mechanisms of resistance, and emerging combination strategies that continue to refine precision oncology approaches in mCRC.

11 days ago

Clinical • Review • Journal

HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene)

BRAF V600E • HER-2 amplification • BRAF V600 • BRAF wild-type

Herceptin (trastuzumab) • Vectibix (panitumumab) • Braftovi (encorafenib) • Tukysa (tucatinib)

11d

Real-world Analysis of Treatment Patterns, Clinical Outcomes, and Molecular Profiling in Advanced Biliary Tract Cancer. (PubMed, Anticancer Res)

The integration of NGS and the subsequent use of matched targeted therapy significantly improved survival outcomes in selected patients with advanced BTC, highlighting the importance of precision medicine strategies.

11 days ago

Clinical data • Retrospective data • Journal • Real-world evidence • IO biomarker

HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • ARID1A (AT-rich interaction domain 1A)

TP53 mutation • KRAS mutation • MSI-H/dMMR • HER-2 amplification • HER-2 mutation • IDH1 mutation • ARID1A mutation • FGFR2 mutation • FGFR2 fusion

11d

Molecular Profiling and Treatment Outcomes in Uterine Serous Carcinoma: Prognostic Role of Estrogen Receptor Expression. (PubMed, Curr Oncol)

USC is a biologically heterogeneous disease, and its treatment should be guided by its molecular profile. ER expression identifies a subset of patients with improved DFS, suggesting potential prognostic relevance in this high-risk histology.

11 days ago

Retrospective data • Journal

HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • PGR (Progesterone receptor)

TP53 mutation • ER positive • HER-2 amplification • ER negative

11d

Magnesium Supplementation in Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)

P2/3, N=230, Not yet recruiting, Swiss Cancer Institute | Initiation date: Dec 2025 --> Jul 2026

11 days ago

Trial initiation date

HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • CD4 (CD4 Molecule)

BRAF V600E • HER-2 amplification • BRAF V600 • HER-2 mutation • RET mutation • RET rearrangement