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 methods : advancing methods and applications2026-10-16

Insights into the degradation behaviour of tucatinib under stress conditions using liquid chromatography high resolution tandem mass spectrometry.

Prasad Kollu Sai Ram SR, Seema Rayeesa R, Swain Debasish D

Tucatinib is a kinase inhibitor drug used to treat unresectable or metastatic HER-2 positive breast cancer in combination with Trastuzumab and Capecitabine. Forced degradation studies assess the inherent stability of pharmaceutical compounds, while LC-MS/MS facilitates the identification and characterization of the resulting degradation products. In the present study, the stability of Tucatinib (TCB) was investigated under various stress conditions (hydrolytic, photolytic, thermal, and oxidative conditions). It was demonstrated that TCB was susceptible to hydrolytic (acid, base, and neutral) as well as oxidative degradation, yielding 11 degradation products, of which 9 are reported for the first time. A validated UHPLC method was developed using an Agilent Eclipse Plus C18 (4.6 × 150 mm, 5 µm) column with gradient elution using 0.1% formic acid in water and methanol as mobile phases. Mass characterization of the degradation products was carried out on an Exploris 120 Orbitrap mass spectrometer using the same chromatographic conditions. Also, degradation kinetics was assessed to define the trend followed by TCB under different stress conditions. Thus, the present study effectively presents a detailed degradation profile of TCB, and the developed method finds its use for the routine analysis of TCB and formulation development in bulk and dosage forms.

PMID 42885763
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PubMedJournal of clinical medicine2026-10-16

HER2-Low Breast Cancer: A Review of Epidemiology, Diagnostic Challenges, Targeted Therapies, and Clinical Outcomes.

Mirasheh Maedeh M, Shahabinia Zahra Z, Abusalah Mai Abdel Haleem A MAHA, Mazidimoradi Afrooz A et al.

Background: Breast cancer is the most common malignancy among women. The HER2-low subgroup represents one of its prevalent subtypes; however, due to its unique characteristics, it presents challenges in diagnosis and treatment, complicating clinical management. This narrative review aims to synthesize evidence regarding the epidemiology, diagnosis, treatment, and prognosis of this subgroup. Methods: In this narrative review, following a search of PubMed, Web of Science, Scopus, and Google Scholar databases and the evaluation of 91 studies, findings were synthesized qualitatively and descriptively. Additionally, cohort studies, systematic reviews, and meta-analyses were utilized to explore associations and summarize prognostic trends. Results: The prevalence of HER2-low varied between 30% and 65% across different populations, with most studies reporting an association with hormone receptor (HR)-positive status and age over 50 years. Diagnostic challenges primarily stemmed from poor inter-pathologist agreement and laboratory variability. However, emerging technologies such as artificial intelligence (AI) and radiomics have shown promising results in diagnosis. Therapeutically, trastuzumab deruxtecan (T-DXd) demonstrated efficacy with response rates ranging from 21% to 62%; nevertheless, cross-resistance to antibody-drug conjugates (ADCs) and high drug costs remain significant barriers. Patient prognosis and survival, beyond HER2 status, depended on factors such as HR status, Ki-67 index, lymph node involvement, and treatment response. Conclusions: HER2-low tumors constitute a distinct, highly prevalent subgroup with specific clinical features, necessitating differentiated diagnostic and therapeutic approaches. Despite the efficacy of T-DXd, obstacles such as intragroup heterogeneity, treatment resistance, high costs, and the lack of standardized diagnostic criteria persist. Therefore, attention to molecular profiling, standardization of diagnostic methods, and the development of cost-effective strategies are essential for equitable access to treatment.

PMID 42882021
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PubMedRSC advances2026-10-15

Mixed-thiol functionalised gold nanoparticles for trastuzumab delivery: chemical interaction and photothermal therapeutic potential.

Salamone Tommaso A TA, Mosetti Rosanna R, D'Arco Annalisa A, Lupi Stefano S et al.

Small-sized gold nanoparticles (AuNPs) functionalised with hydrophilic thiols were investigated. Sodium 3-mercapto-1-sulfonate and 2-(diethylamino)ethanethiol hydrochloride were used as stabilising agents in a wet synthesis approach to provide a stable colloidal system. AuNPs were loaded with the antibody trastuzumab (TZ) to evaluate the potential use of the system for photothermal-assisted controlled drug release. Furthermore, to gain a deeper understanding of the chemical interactions occurring at the interface between TZ and the surface thiols of the nanoparticles, FT-IR studies were performed both in the solid state and in suspension, suggesting a strong interaction between the surface thiols and the amidic functional groups of TZ. The photothermal (PT) behaviour of the pristine AuNPs was investigated under continuous-wave laser irradiation at 532 nm, matching the plasmon resonance band of the gold nanoparticles, resulting in an up to 20 °C temperature increase. FT-IR measurements were also carried out after laser irradiation to evaluate the potential for a controlled release of TZ from the nanoparticle surface, suggesting that light irradiation can trigger the release of the drug from the AuNPs surface, with no detrimental effect from the temperature increase. Finally, SAXS studies enabled the investigation of TZ loading and release kinetics via in situ studies over 3 hours. This work provided a detailed investigation of the interfacial chemical interactions, also giving a dual potential application of the hybrid, evaluating its use for PT therapy and for PT-assisted controlled release of the antibody.

PMID 42877328
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PubMedBreast (Edinburgh, Scotland)2026-10-15

Clinical features associated with exceptional response on first-line anti-HER2-based therapy for metastatic breast cancer: real-world data from the ESME national cohort.

Grinda Thomas T, Carton Matthieu M, Morganti Stefania S, Mailliez Audrey A et al.

Some patients with HER2-positive metastatic breast cancer (MBC) achieve prolonged disease control with first-line anti-HER2-based therapy, but associated clinical features remain poorly characterized in real-world populations. We conducted a retrospective study using the Epidemiological Strategy and Medical Economics (ESME) MBC cohort, including 18 French comprehensive cancer centers. Women with HER2-positive MBC who initiated first-line anti-HER2-based therapy between January 2008 and December 2021 and had at least 3 years of follow-up were eligible. Exceptional responders had no documented progression within 3 years. A secondary analysis evaluated factors associated with remaining progression-free at 5 years. Multivariable logistic regression with bootstrap cross-validation was used. Among 4307 eligible patients, 1016 (23.6%) were exceptional responders. Of 765 evaluable at 5 years, 523 (68.4%) remained progression-free. Factors associated with a lower likelihood of exceptional response included hormone receptor-negative (HR-) disease, a disease-free interval of 6-24 months, ≥3 metastatic sites, visceral metastases, and central nervous system involvement. First-line treatment with chemotherapy, trastuzumab, and pertuzumab was associated with exceptional response. Among exceptional responders, HR-disease, grade III tumors and first-line chemotherapy plus trastuzumab and pertuzumab were associated with progression-free at 5-year, whereas visceral metastases were associated with lower odds. Model discrimination was moderate (AUC 0.72 and 0.64, respectively). Nearly one quarter of patients remained progression-free for at least 3 years, and more than two thirds of those evaluable remained progression-free at 5 years. Clinical variables alone had limited predictive value, supporting the need for molecular and immune biomarkers to better identify this subgroup.

PMID 42880095
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PubMedBreast (Edinburgh, Scotland)2026-10-15

Chemotherapy outcomes in human epidermal growth factor receptor 2-low, hormone receptor-positive metastatic breast cancer: Insights from the French multicenter ESME database.

Jacot William W, Macouillard Pauline P, Zhang Suyuan S, Byng Danalyn D et al.

The human epidermal growth factor receptor 2 (HER2)-targeted therapy trastuzumab deruxtecan has demonstrated significantly improved efficacy versus chemotherapy in HER2-low or -ultralow, hormone receptor (HR)-positive metastatic breast cancer (mBC) following endocrine therapy (ET). This study describes current real-world characteristics and outcomes for this population in France to inform optimized treatment sequencing, including the potential benefits of novel treatments. Data were obtained from the Unicancer Epidemiological Strategy and Medical Economics (ESME) MBC database of adult patients with mBC. Patients were diagnosed with HER2-low, HR-positive mBC between 2008 and 2022 and initiated a chemotherapy-based regimen (index line of therapy [LOT]) after ≥1 qualifying line of ET. Real-world overall survival (rwOS) and progression-free survival (rwPFS) were assessed from the start of index LOT. Among 326 patients selected, index LOT was third line (3L) or greater ("index 3L+ group") for 202 (62.0%) patients and second line for 124 (38.0%) patients; 101 (31.0%) patients initiated index LOT after progression within 6 months of first-line ET + cyclin-dependent kinase 4/6 inhibitor ("rapid progressors"). Median rwOS (95% confidence interval [CI]) for the overall cohort, index 3L+ group, and rapid progressors was 23.1 (19.7, 27.5), 27.6 (22.7, 31.3), and 18.6 (14.3, 23.0) months, respectively. Median rwPFS (95% CI) for the overall cohort, index 3L+ group, and rapid progressors was 5.1 (4.8, 5.7), 5.2 (4.7, 6.0), and 5.6 (4.6, 6.3) months, respectively. These real-world data suggest limited long-term efficacy of chemotherapy-based treatments for patients with ET-resistant HER2-low, HR-positive mBC, emphasizing high unmet need in this population.

PMID 42880094
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PubMedMolecular informatics2026-10-14

Identification of YES1 Inhibitors From Approved Drugs Using a Multimodal Deep Learning Framework.

Kawabata Takayoshi T, Takeda Tatsuaki T, Tanaka Yuta Y, Ushio Soichiro S et al.

While anti-human epidermal growth factor receptor 2 (HER2) drugs, including trastuzumab improve the prognosis of patients with HER2-positive cancers, acquired resistance by cancer cells remains a significant clinical challenge. We had previously reported that YES1 is overexpressed in trastuzumab-resistant breast and lung cancer cells, and that its inhibition restores trastuzumab sensitivity. However, no approved drug specifically targets YES1. In this study, as a drug repositioning approach aimed at rapid clinical application, we constructed a machine learning model capable of learning the interactions between compounds and target proteins and conducted a screening of approved drugs. The strategy identified chlorpromazine and raloxifene as hit compounds. In vitro validation demonstrated that they effectively inhibited YES1 activation at 15 μM after 48 h. The findings suggested that the identified approved drugs might represent promising therapeutic options for overcoming anti-HER2 drug resistance.

PMID 42873192
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