Drug Database
TR

trastuzumab (HS 022 / HS022 / anruize)

✓ Approved

BioRay Pharmaceutical · ERBB2 · Monoclonal Antibodies

What is trastuzumab?

trastuzumab is a monoclonal antibodies developed by BioRay Pharmaceutical. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

Brand NamesHS 022, HS022, anruize
CompanyBioRay Pharmaceutical
Drug ClassMonoclonal Antibodies, Antibody
Molecular TargetERBB2
RouteInjectable (Others), Intravenous (IV)
StatusApproved
Sources: ClinicalTrials.gov, BioRay Pharmaceutical

Mechanism of Action

Molecular Targets

trastuzumab acts on 1 molecular target:

ERBB2erb-b2 receptor tyrosine kinase 2 (NEU, CD340)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

trastuzumab is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Breast cancer✓ Approved
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Gastric cancer✓ Approved

Related Research Articles

PubMedAnalytical chemistry2026-11-11

Probing Molecular Binding Mechanisms between a Therapeutic Antibody and an Antigen Mimotope Peptide In Situ in Real Time at a Buried Interface.

Wu Guangyao G, Qin Xiaoxue X, Fathi Fatemeh F, Chen Xuhong X et al.

Bioanalytical platforms, such as biosensors and biochips, are widely used for detecting biomolecules including antibodies. Determining the conformation and orientation of antibodies captured by surface-immobilized recognition elements is essential for designing biosensors and biochips with improved performance. However, obtaining such structural information remains challenging because antibodies are located at buried solid/liquid interfaces that are difficult to characterize. Here, we investigated the binding interaction between Herceptin (trastuzumab), a therapeutic monoclonal antibody, and CH19, a HER2 mimotope peptide immobilized at a buried solid/liquid interface. Sum frequency generation (SFG) vibrational spectroscopy revealed specific binding of Herceptin to the surface-immobilized CH19 peptide, whereas no detectable interaction was observed for the non-target antibodies Cetuximab and Rituximab. By integrating SFG measurements with molecular dynamics (MD) simulations and one-exciton Hamiltonian spectral calculations, we determined the interfacial molecular structure of Herceptin and found that the antibody adopts a lying-down orientation on the CH19-functionalized surface. These combined experimental and computational results demonstrate that CH19-Herceptin recognition at the interface differs fundamentally from the corresponding interaction in solution, highlighting the unique influence of interfacial environment on antibody-antigen recognition. Our results support a surface-enabled multivalent binding model, in which multiple immobilized CH19 peptides interact with broader regions of Herceptin and generate a contact pattern distinct from that in solution. These results demonstrate that the combined SFG, MD, and spectral-calculation approach can determine the molecular structure of a full-length antibody at a buried interface, offering valuable insights for the rational design of biosensors, biochips, and other surface-based biorecognition analytical technologies.

PMID 43010483
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PubMedCureus2026-11-10

Sequential Anti-HER2 (Human Epidermal Growth Factor Receptor 2) Therapy and Late-Line Tucatinib in Patients With HER2-Positive Breast Cancer and Brain Metastases: A Real-World Case Report.

Thakur Purnima P, Gupta Manish M, Kant Lalit C LC, Mehta Priya P et al.

Human epidermal growth factor receptor 2 (HER2)-positive breast cancer is associated with a high incidence of brain metastases (BMs), particularly among young and heavily pretreated patients, with intracranial disease remaining a major determinant of survival and quality of life (QoL). Tucatinib, a HER2-selective tyrosine kinase inhibitor (TKI), combined with trastuzumab and capecitabine, has demonstrated significant progression-free survival (PFS) and overall survival (OS) benefit, including in patients with active BMs. We present the case reports of two patients, both younger than 50 years, with HER2-positive metastatic breast cancer and biologically aggressive disease who progressed on prior anti-HER2 therapy (trastuzumab, lapatinib, and ado-trastuzumab emtansine (Ujvira™) in Case 1 and trastuzumab in Case 2) with worsening central nervous system involvement. Both were subsequently treated with tucatinib-based combination therapy (Tukavo™) later in the treatment sequence, once it became available and affordable, and showed clinical and radiological improvement. Case 1 had improvement in right-sided limb weakness and speech with no further seizures and remained clinically stable for seven months, and Case 2 had complete resolution of headache and vomiting, with Eastern Cooperative Oncology Group (ECOG) performance status improving from 2 to 1. QoL was assessed clinically from symptoms and performance status rather than with a validated instrument. This real-world experience illustrates the potential benefit of tucatinib-based regimens in young patients with aggressive HER2-positive breast cancer and BMs, even when used later in the treatment sequence. These findings are consistent with pivotal trial data in a resource-limited, real-world setting.

PMID 43004999
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PubMedEuropean journal of physical and rehabilitation medicine2026-11-10

The clinical efficacy of a tailored exercise program on cardiopulmonary function and fatigue in patients with HER2-positive breast cancer undergoing trastuzumab treatment: a post-hoc analysis of the CARDAPAC study.

Jacquinot Quentin Q, Meneveau Nathalie N, Falcoz Antoine A, Roux Pauline P et al.

Physical exercise is increasingly recognized as an effective non-pharmacological intervention to mitigate treatment-related adverse effects in cancer patients. However, evidence remains limited regarding the benefits of structured exercise programs in HER2-positive breast cancer patients treated exclusively with trastuzumab. To investigate the impact of a 3-month supervised, tailored exercise program on fatigue and cardiorespiratory fitness in this population. Phase II, randomized, prospective, multicenter trial. Outpatient oncology centers. Eighty-nine women with HER2-positive breast cancer receiving adjuvant trastuzumab. Participants were randomly assigned to a training group (TG) undergoing 36 supervised intermittent aerobic exercise sessions (55 minutes/session, 3 days/week, combining moderate and high intensities) or to a control group (CG) receiving usual care. Cardiopulmonary exercise testing and fatigue assessments (MFI-20) were conducted at baseline (T0), 3 months (T3), and 6 months (T6) post-intervention. At T3, TG showed clinically meaningful improvements in peak oxygen uptake (+2.6 mL/min/kg; 95% CI: 1.8-3.4), oxygen pulse (+0.7 mL/beat), and maximal power output (+21.3 W). Ventilatory thresholds (VT) occurred at higher workloads with reduced heart rate and respiratory rate at submaximal intensities, indicating improved aerobic efficiency. Scores for general fatigue, physical fatigue, and reduced activity significantly decreased, although these changes did not reach the minimal clinically important difference. Moderate negative correlations were observed between fatigue scores and V̇O2 at VT1 and V̇O2 peak, suggesting that improved fitness may alleviate fatigue. A tailored, supervised exercise program significantly enhances cardiorespiratory fitness and reduces fatigue symptoms in HER2-positive breast cancer patients treated with trastuzumab. Specifically, a clinically meaningful increase in peak V̇O2, maximal power output, and oxygen pulse was observed, along with significant reductions in general fatigue, physical fatigue, and reduced activity scores. Incorporating supervised, individualized exercise into standard oncology care improves functional capacity and fatigue management, supporting its integration into rehabilitation programs for this population.

PMID 43006465
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PubMedCancer immunology research2026-11-10

Engineered stem cell-derived CD16-enhanced universal NKT cells improve monoclonal antibody-based cancer immunotherapy.

Li Yan-Ruide YR, Zhu Yichen Y, Yu Yanqi Y, Kramer Adam A et al.

Monoclonal antibody (mAb)-based therapies have revolutionized cancer treatment; however, their clinical efficacy is often limited by insufficient antibody-dependent cellular cytotoxicity (ADCC), tumor antigen escape, and an immunosuppressive tumor microenvironment (TME). To overcome these limitations, we developed an allogeneic stem cell-derived invariant natural killer T (NKT) cell platform engineered to express a high-affinity non-cleavable CD16 receptor (CD16HSC-NKT) for broad enhancement of mAb-based immunotherapy. Using a clinically guided differentiation platform, we generated highly pure and scalable CD16HSC-NKT cells exhibiting robust expression of NK receptors, potent cytotoxic machinery, and a Th1-biased cytokine profile. CD16HSC-NKT cells demonstrated potent intrinsic antitumor activity and potently enhanced the efficacy of multiple therapeutic antibodies, including Trastuzumab, Tafasitamab, Rituximab, Daratumumab, and Cusatuzumab, across diverse hematologic and solid tumor models. In vivo, combination therapy induced durable tumor eradication and prolonged survival in xenograft models, outperforming the clinically approved antibody-drug conjugate trastuzumab deruxtecan. Mechanistically, therapeutic antibodies promoted the expansion, persistence, and activation of CD16HSC-NKT cells within tumors. CD16HSC-NKT uniquely remodeled the TME by selectively depleting CD1d-expressing tumor-associated macrophages and myeloid-derived suppressor cells. CD16HSC-NKT cells also exhibited minimal alloreactivity, no graft-versus-host disease, and no detectable systemic toxicity. Collectively, these findings establish CD16HSC-NKT cells as a safe, off-the-shelf cellular platform capable of broadly enhancing monoclonal antibody therapy through sustained ADCC, multimodal tumor targeting, and TME remodeling.

PMID 43008138
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PubMedCancer medicine2026-11-10

Real-World Progression Patterns and Potential Prognostic Factors for Trastuzumab Deruxtecan-Related Interstitial Lung Disease in Japanese Patients With Breast or Gastric Cancer.

Sasaki Shinichi S, Oikado Katsunori K, Baba Tomohisa T, Kusumoto Masahiko M et al.

Interstitial lung disease (ILD)/pneumonitis is a safety concern with trastuzumab deruxtecan (T-DXd). We characterized post-onset changes in ILD severity and imaging patterns, and explored potential prognostic factors for fatal T-DXd-related ILD in Japanese patients with breast or gastric cancer. This post hoc analysis included 381 independently adjudicated T-DXd-related ILD cases from two Japanese all-patient post-marketing surveillance studies. We described transitions from onset to worst Common Terminology Criteria for Adverse Events grade and imaging pattern changes. Exploratory tumor type-stratified Cox proportional hazards models were used to assess factors associated with time to fatal (Grade 5) ILD. The variable with the highest hazard ratio (HR) and each of the remaining significant univariate factors (p < 0.05 or a 95% confidence interval excluding 1) meeting the criteria were included in two-covariate multivariable models. At ILD onset, 60.1% of patients had Grade 1 ILD. Overall, 30 of the 381 adjudicated ILD cases (7.9%) progressed to fatal Grade 5, initially presenting with Grade 1 (n = 9), 2 (n = 5), or 3 (n = 16); time to death was 3-173 days. Of 24 cases with imaging pattern changes, 14 transitioned from nondiffuse alveolar damage (non-DAD) to DAD (10 were fatal). Abnormal C-reactive protein (CRP) at onset had the highest HR in univariate analyses. In separate CRP-adjusted two-covariate multivariable models, preexisting ILD and several onset factors (dyspnea; abnormal SpO2/lactate dehydrogenase/Krebs von den Lungen-6; pleural/cardiac effusion; DAD pattern; traction bronchiectasis) were associated with fatal ILD. An organizing pneumonia pattern was associated with a lower hazard. T-DXd-related ILD may progress rapidly to fatal outcomes, even from low-grade or non-DAD presentations, and several onset factors (e.g., elevated CRP, decreased SpO2, and DAD pattern) were associated with fatal ILD outcomes. These findings are exploratory and should not be used to determine whether to initiate or withhold corticosteroids. Guideline-concordant ILD management remains essential regardless of these factors, while their potential role in identifying patients requiring closer monitoring warrants further validation. The breast cancer and the gastric cancer surveys were registered at the Japan Registry of Clinical Trials (https://jrct.mhlw.go.jp/en-top) under the identifiers jRCT1080225197 and jRCT2001200001, respectively.

PMID 43004521
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PubMedCurrent oncology reports2026-11-10

HER2-Positive Biliary Tract Cancer in 2026: From Genomic Profiling and HER2 Phenotyping to Treatment Selection and Sequencing.

Sagawa Tamotsu T, Hirakawa Masahiro M, Nagashima Hiroyuki H, Fujikawa Koshi K

Human epidermal growth factor receptor 2 (HER2) is actionable in biliary tract cancer (BTC), but protein overexpression, ERBB2 amplification, and activating mutations are not therapeutically equivalent. This review integrates genomic profiling, HER2 phenotyping, and contemporary HER2-directed evidence into a practical framework for treatment selection and sequencing in 2026. In the final HERIZON-BTC-01 analysis, confirmed ORR by independent central review was 51.6% in the IHC 3+ cohort (n=62) and 5.6% in the IHC 2+ cohort (n=18). In DESTINY-PanTumor02, investigator-assessed ORR was 22.0% (9/41) overall and 56.3% (9/16) in centrally reassessed IHC 3+ BTC; independent central-review ORR was 26.8% (11/41) overall, without a published IHC-specific central-review estimate. These assessor-dependent results are not directly comparable with one another or with HERIZON-BTC-01. HERALD/EPOC1806 supports plasmadetected ERBB2 amplification as a selection route for trastuzumab deruxtecan in solid tumors, but enrolled only four BTC patients. First-line combinations are under prospective study. The practical model is broad genomic profiling plus precise HER2 phenotyping. IHC 3 + provides the strongest BTC-specific treatment signal; IHC 2+/ISH+, activating ERBB2 mutation, and low-expression or amplification-only states require treatment-specific interpretation. Post-HER2 sequencing remains evidence-poor and should incorporate prior exposure, toxicity, clinical tempo, organ function, and regional access.

PMID 43007564
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