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

PubMedBioelectrochemistry (Amsterdam, Netherlands)2026-08-30

Super-antifouling electrochemical biosensor based on a biomimetic gemini zwitterionic interface for sensitive detection of therapeutic antibodies.

Zhao Zheng Z, Yu Wanqing W, Li Haidong H, Hai MingFang M et al.

Biofouling, arising from the nonspecific adsorption of proteins, cells, and other biomolecules, remains a major challenge that compromises the stability and reliability of diagnostic and therapeutic platforms. To address this issue, a super-antifouling electrochemical aptasensor was developed by integrating a biomimetic "gemini" zwitterionic monomer (BSMMP) with polydopamine (PDA). The covalent assembly of BSMMP and PDA forms a multi-site anchoring layer that enables the stable functionalization of the affinity aptamer GC20. Owing to its dense hydration shell, the PDA-BSMMP hybrid interface acts as a physical barrier against nonspecific adsorption, maintaining electron-transfer stability in undiluted human serum. Differential pulse voltammetry confirmed that this interface markedly reduced biofouling-induced signal loss, limiting attenuation to less than 15%, nearly fourfold lower than that of the unmodified surface. The platform achieved a low limit of detection of 0.97 ng/mL, a broad linear range from 1 ng/mL to 100 μg/mL, and high selectivity for trastuzumab in a label-free format without secondary antibodies or additional signal amplification. Finally, this platform successfully quantified trastuzumab in serum from breast cancer patients, with results consistent with commercial ELISA kits. Overall, this super-antifouling aptasensor offers great potential for therapeutic drug monitoring, advancing zwitterionic interface-based biosensing strategies for point-of-care diagnostics.

PMID 42669258
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PubMedFrontiers in pharmacology2026-08-29

Correction: Investigation of potential sex-based differences in trastuzumab-induced chronic cardiotoxicity in a rat model.

Losonczi Réka R, Galla Zsolt Z, Kis Merse M, Kupecz Klaudia K et al.

[This corrects the article DOI: 10.3389/fphar.2026.1809964.].

PMID 42666639
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PubMedAdvances in therapy2026-08-29

Effectiveness and Safety of Trastuzumab Deruxtecan in Chinese Patients with HER2-Mutant Metastatic Non-Small Cell Lung Cancer (RERUN): Study Protocol for a Real-World, Multicenter, Prospective, Observational Study.

Duan Jianchun J, Zhuo Minglei M, Su Chunxia C, Liu Yibing Y et al.

Trastuzumab deruxtecan (T-DXd) is a human epidermal growth factor receptor 2 (HER2)-targeting antibody-drug conjugate that has demonstrated encouraging efficacy and a manageable safety profile in the second-line or later setting for non-small cell lung cancer (NSCLC) harboring HER2 mutations. While T-DXd was approved for treating patients with locally advanced or metastatic HER2-mutant NSCLC in China, real-world data on its use in Chinese clinical practice are lacking. This study will collect real-world data on T-DXd to evaluate its effectiveness and safety in Chinese patients with HER2-mutant metastatic NSCLC, thereby providing additional evidence to the oncology community in China. RERUN is a prospective, multicenter, observational cohort study conducted at approximately 30 sites in China. Approximately 150 adult patients (≥ 18 years) with pathologically documented unresectable and/or metastatic non-squamous NSCLC harboring any known activating HER2 mutation are currently being enrolled. The follow-up period will last approximately 6 months after the last patient is enrolled, when sufficient progression-free survival (PFS) maturity (approximately 60% of patients with events) is expected to be reached. All data will be prospectively collected and analyzed descriptively. The primary outcome is real-world PFS assessed by investigators in patients receiving T-DXd as second-line or later therapy. Secondary outcomes include the time to treatment discontinuation or death, best overall response rate, overall survival, and safety and tolerability. This study will support treatment decision-making in routine oncology practice and improve outcomes for Chinese patients with HER2-mutant NSCLC across diverse healthcare settings. Study registration number NCT06809764.

PMID 42667570
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PubMedJournal of gastrointestinal cancer2026-08-28

HER2-Targeted Therapy for Metastatic Colorectal Cancer: Current Evidence, Patient Selection, and Practical Treatment Sequencing.

Sagawa Tamotsu T, Nagashima Hiroyuki H, Fujikawa Koshi K

HER2 has emerged as an actionable molecular alteration in metastatic colorectal cancer (mCRC), particularly in patients with RAS wild-type disease and tumors with strong HER2 overexpression or ERBB2 amplification. Once recognized mainly as a mechanism of resistance to anti-EGFR therapy, HER2 now defines a therapeutically relevant subgroup. Dual HER2 blockade with trastuzumab-based combinations and antibody-drug conjugates, particularly trastuzumab deruxtecan, have demonstrated clinically meaningful activity in treatment-refractory disease. Emerging phase III data with trastuzumab rezetecan further support HER2-directed therapy, although peer-reviewed publication, regulatory status, and regional availability remain important considerations. This narrative review focuses on the practical integration of HER2 testing and HER2-directed treatment into mCRC care. We summarize colorectal cancer-specific diagnostic approaches, evidence for established and emerging regimens, and treatment-selection considerations according to RAS/BRAF status, HER2 expression level, prior anti-EGFR exposure, comorbidities, toxicity risk, and local access. We also discuss the complementary roles of tissue testing and circulating tumor DNA, including repeat molecular assessment at progression. Finally, we propose a clinician-oriented framework for early patient identification, treatment sequencing, and resistance assessment. Optimal sequencing between dual HER2 blockade and antibody-drug conjugates remains uncertain and requires prospective evaluation.

PMID 42663748
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PubMedIn vivo (Athens, Greece)2026-08-28

Efficacy of S-1 Monotherapy for Salivary Duct Carcinoma With MYC Amplification.

Suto Hirotaka H, Kawamura Miyuki M, Morita Mitsunori M, Sakai Hideki H et al.

Salivary duct carcinoma (SDC) is a rare, highly aggressive subtype of salivary gland carcinoma, commonly characterized by overexpression of erb-b2 receptor tyrosine kinase 2 [ERBB2, commonly known as human epidermal growth factor receptor 2 (HER2)] and androgen receptor positivity. Anti-HER2 therapy, platinum-based chemotherapy, and androgen-deprivation therapy (ADT) are commonly provided as standard systemic treatments for advanced SDC; however, effective therapeutic options after failure of these treatments remain limited. The clinical efficacy of S-1 monotherapy in SDC and its predictive biomarkers are not well established. Herein, we present a case in which S-1 monotherapy showed efficacy in a case of SDC after resistance to anti-HER2 therapy, platinum-based chemotherapy, and ADT. The patient was a 70-year-old man diagnosed with HER2-positive and androgen receptor-positive SDC of the submandibular gland, who presented with multiple lung metastases. He initially received trastuzumab plus docetaxel as first-line therapy, followed by platinum-based chemotherapy and ADT, but experienced disease progression after each treatment. Comprehensive genomic profiling revealed amplifications of ERBB2 and MYC proto-oncogene bHLH transcription factor (MYC). S-1 monotherapy was started as a late-line therapy. Computed tomography scans 2 months later showed shrinkage of lung and liver metastases, with disease control maintained for more than 5 months. S-1 monotherapy may represent a treatment option for patients with advanced SDC refractory to anti-HER2 therapy, platinum-based chemotherapy, and ADT, particularly in cases harboring MYC amplification.

PMID 42665401
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PubMedModern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc2026-08-28

HER2 Intratumoral Heterogeneity in Salivary Duct Carcinoma: Association With Treatment Response and Comparison Between Primary and Metastatic Lesions.

Utsumi Yoshitaka Y, Nakaguro Masato M, Kawakita Daisuke D, Honma Yoshitaka Y et al.

Salivary duct carcinoma (SDC) is a rare and aggressive malignancy, with up to half of cases being HER2-positive. Trastuzumab combined with docetaxel (Tmab + DTX) is a key therapeutic regimen for unresectable HER2-positive SDC; however, robust predictors of the treatment response in this patient population remain undefined. Although HER2 intratumoral heterogeneity (ITH) and the degree of HER2 amplification are known to correlate with the response to HER2-targeted agents in breast and gastric cancers, their predictive relevance in SDC remains unclear. To address this issue, we retrospectively analyzed 98 patients with unresectable HER2-positive SDC treated with Tmab + DTX. In this study, HER2 ITH was defined based on the 2023 ASCO/CAP breast cancer guidelines as the presence of spatially distinct HER2-positive and HER2-negative regions, each comprising ≥10% of the tumor area, evaluated using both immunohistochemistry (IHC) and dual-color in situ hybridization (DISH). HER2 ITH was identified in 11 of the 98 cases (11.2%). The results of IHC and DISH demonstrated strong concordance, with the exception of 1 sarcomatoid case. HER2 ITH was identified only in resected primary tumor specimens. In HER2 ITH-positive cases, no HER2 ITH was observed in any available synchronous or metachronous metastatic lesions, and the HER2 status was concordant across metastatic lesions within each patient, with most lesions being HER2-positive. The cohort exhibited an objective response rate of 80.6%, with median progression-free survival and overall survival of 9.9 and 43.8 months, respectively. No significant associations were observed between HER2 ITH or other HER2 parameters (HER2 IHC score, HER2 copy number, or HER2/CEP17 ratio) and any clinical outcome measures. The predominance of HER2-positive metastatic lesions may explain the lack of association between HER2 ITH in primary tumors and treatment efficacy. In this largest cohort of HER2-positive SDC patients treated with Tmab + DTX, HER2 ITH was present in a clinically relevant subset of cases. In contrast to breast and gastric cancers, neither HER2 ITH nor HER2 amplification levels were associated with the therapeutic response. Our findings suggest that the presence of HER2 ITH may not preclude the use of HER2-targeted therapy in SDC.

PMID 42660427
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