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

PubMedAmerican heart journal plus : cardiology research and practice2026-09-19

Association of statin use and left ventricular function in patients with breast cancer receiving trastuzumab.

Nochioka Kotaro K, Terui Yosuke Y, Udagawa Aika A, Kato Shintaro S et al.

We examined the association between statin use and changes in left ventricular ejection fraction (LVEF) during trastuzumab therapy in women with breast cancer. Methods: This post-hoc analysis of the CHECK HEART-BC study included 215 patients with normal baseline LVEF and 12-month echocardiographic follow-up. We assessed LVEF at baseline and at 3, 6, 9, and 12 months by statin use. Of 215 women, 31 (14%) were receiving statins. Baseline LVEF was comparable between groups. After a similar decline at 3 months, LVEF trajectories diverged, with better preservation among statin users apparent at 9 months and most pronounced at 12 months. Statin use was associated with attenuated LVEF decline over time in an adjusted longitudinal model (interaction estimate, 0.27; standard error, 0.10; P = 0.005). Statin use was associated with better LVEF preservation during trastuzumab therapy, particularly during later follow-up. These findings are hypothesis generating and require confirmation in randomized trials.

PMID 42761834
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PubMedTargeted oncology2026-09-19

Summary of Research: HER2CLIMB-05: A Phase III Study of Tucatinib Versus Placebo in Combination with Trastuzumab and Pertuzumab as First-Line Maintenance Therapy for HER2+ Metastatic Breast Cancer.

Dieras Veronique V, Curigliano Giuseppe G, Martin Miguel M, Lerebours Florence F et al.

This is a summary of a research article reporting the findings of the HER2CLIMB-05 trial (NCT05132582), a randomized, double-blind, placebo-controlled, international, phase III trial. The HER2CLIMB-05 trial was conducted to compare the efficacy and safety of adding tucatinib versus placebo to first-line maintenance therapy (trastuzumab and pertuzumab) following induction chemotherapy, in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer. The key finding of the HER2CLIMB-05 trial was that progression-free survival was significantly improved in the tucatinib arm over the control arm (24.9 vs 16.3 months). The safety profile of tucatinib plus maintenance therapy was consistent with the known toxicities of each individual drug. The HER2CLIMB-05 regimen, with its high efficacy and manageable toxicity, represents a valuable option for first-line maintenance therapy in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer.

PMID 42762393
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PubMedFrontiers in medicine2026-09-18

Neoadjuvant pembrolizumab-based therapy versus dual HER2 blockade in early breast cancer: comparable surgical complication rates in a real-world cohort.

Wimmer Kerstin K, Kantner Katharina K, Exner Ruth R, Bartsch Rupert R et al.

Neoadjuvant systemic therapy (NST) has become a cornerstone in the management of aggressive early breast cancer (BC) subtypes, including triple-negative (eTNBC) and HER2-positive disease. Immune checkpoint inhibition with pembrolizumab represents an active immunotherapeutic approach, whereas dual HER2 blockade with trastuzumab and pertuzumab constitutes passive immunotherapy in early HER2-positive BC. Although both strategies demonstrate substantial antitumor efficacy, real-world data directly comparing their surgical safety profiles are limited. This retrospective single-center cohort study included 99 patients with early BC treated with NST between 2014 and 2025. A total of 33 patients with TNBC received pembrolizumab-based therapy according to the KEYNOTE-522 regimen, whereas 66 patients with HER2-positive disease received chemotherapy combined with trastuzumab and pertuzumab. Surgical adverse events within 30 days postoperatively were assessed using the Clavien-Dindo classification and the Comprehensive Complication Index (CCI). Complication rates and severity were compared between groups. The overall postoperative complication rate was 25.3%, with no significant difference between TNBC and HER2-positive cohorts (27.3% vs. 24.2%, p = 0.744). Most complications were minor (Clavien-Dindo ≤II), and rates of major complications (≥IIIa) did not differ between groups (p = 0.706). Mean CCI scores were comparable (22.1 vs. 24.4; p = 0.630). Seroma formation was the most frequent adverse event in both cohorts. In an exploratory multivariable logistic regression analysis, treatment group was not independently associated with postoperative complications. Pathological complete response rates were 63.6% in TNBC and 45.5% in HER2-positive patients. No clinically relevant delays in adjuvant radiotherapy occurred. No statistically significant differences in postoperative morbidity were observed between treatment groups. These findings support the feasibility of integrating both neoadjuvant treatment strategies into routine surgical practice; however, confirmation in larger prospective studies is warranted.

PMID 42755968
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PubMedClinical Medicine Insights. Oncology2026-09-18

Efficacy and Safety Ranking of HER2-Targeted TKIs in Advanced Breast Cancer: A Bayesian Network Meta-Analysis.

Li Rongjie R, Huangfu Rui R, Lan Hua H, Zhang Chenying C et al.

To compare the efficacy and safety of HER2-targeted tyrosine kinase inhibitors (TKIs) in patients with HER2-positive advanced or locally advanced breast cancer using a Bayesian network meta-analysis and to provide comparative evidence for individualized treatment decisions. PubMed, Embase, Web of Science, and the Cochrane Library were systematically searched for randomized controlled trials evaluating HER2-targeted TKIs in patients with HER2-positive advanced or locally advanced breast cancer. Progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and disease control rate (DCR) were assessed as efficacy outcomes, while treatment-related adverse events were evaluated as safety outcomes. A Bayesian network meta-analysis was performed using R (version 4.2.2) and Stata (version 16.0). Treatments were ranked according to the surface under the cumulative ranking curve (SUCRA). The study protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO: CRD420250650274). Fourteen randomized controlled trials involving 5,289 patients were included. According to SUCRA rankings, pyrotinib plus capecitabine (Pyrotinib_C) showed the highest probability of favorable ranking PFS, ORR, and DCR. Tucatinib combined with trastuzumab and capecitabine (Tucatinib_T_C) demonstrated the highest probability of favorable OS ranking. Regarding safety, pyrotinib combined with trastuzumab and capecitabine (Pyrotinib_T_C) was associated with the highest incidence of serious adverse events, diarrhea, and hand-foot syndrome, whereas Pyrotinib_C showed the highest incidence of anemia and lapatinib plus capecitabine (Lapatinib_C) demonstrated the highest incidence of rash. Among currently available HER2-targeted TKIs, Pyrotinib_C showed the highest probability of favorable ranking for PFS and tumor response outcomes, whereas Tucatinib_T_C showed the highest probability of favorable OS ranking. However, pyrotinib-containing regimens were associated with a higher risk of treatment-related toxicities. These findings highlight the importance of balancing efficacy and safety when selecting HER2-targeted TKI therapies and support individualized treatment strategies for patients with HER2-positive advanced breast cancer.

PMID 42756652
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PubMedJournal of pharmaceutical and biomedical analysis2026-09-18

Development and application of antibody framework region-targeted cross-linking mass spectrometry for epitope screening within patient-derived immune complexes.

Aibara Nozomi N, Yamazawa Ryuji R, Matsugi Yuya Y, Kutsuna Yuki Jimbayashi YJ et al.

Identification of antibody-binding epitopes on antigens is essential for understanding the pathogenic roles of immune complexes (ICs) in autoimmune diseases and for the development of diagnostics and therapeutics. However, methods for direct epitope characterization of IC-antigens formed in vivo remain limited. Here, we investigated antibody framework region (FR)-targeted cross-linking mass spectrometry (XL-MS) as an approach to identify epitopes in patient-derived ICs. Four IC models with known epitopes (tumor necrosis factor alpha-adalimumab, tumor necrosis factor alpha-infliximab, human epidermal growth factor receptor 2-pertuzumab, and human epidermal growth factor receptor 2-trastuzumab) were analyzed using three cross-linkers of different lengths: bis(sulfosuccinimidyl) suberate (BS3), bis(sulfosuccinimidyl) glutarate (BS2G), and 1,1'-carbonyldiimidazole (CDI). BS3 preferentially generated antigen-FR cross-links, whereas CDI predominantly produced antigen-complementarity-determining region cross-links. Several cross-linked peptides contained antigen sequences overlapping previously reported epitopes, supporting the validity of this approach for epitope mapping. As a proof-of-concept clinical application, serum samples from patients with primary biliary cholangitis were analyzed using a targeted database containing four disease-associated autoantigens (PDC-E2, BCOADC-E2, OGDC-E2, and E3BP). Two candidate epitope peptides were identified. One corresponded to a known immunodominant epitope, whereas the other represented a novel candidate site supported by computational epitope prediction analysis. These findings demonstrate that FR-targeted XL-MS provides a strategy for identifying epitopes within patient-derived IC-antigens through the use of conserved antibody FRs. This approach may contribute to understanding antigen recognition mechanisms in autoimmune diseases and support the discovery of disease-relevant therapeutic targets.

PMID 42759225
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PubMedCancer management and research2026-09-17

Serum NGAL and G-CSFR as Predictive and Prognostic Biomarkers for Trastuzumab-Based Therapy in HER2-Positive Gastric Cancer: A Retrospective Study.

Ying Jingwen J, Wang Zui Z, Wang Jing J, Xia Minming M

To evaluate serum neutrophil gelatinase-associated lipocalin (NGAL) and granulocyte colony-stimulating factor receptor (G-CSFR) in predicting efficacy and prognosis of trastuzumab-based targeted therapy in HER2-positive gastric cancer patients. This retrospective study enrolled 150 patients with HER2-positive gastric cancer who were admitted to our hospital between January 2023 and January 2025. All patients received trastuzumab-based combination chemotherapy (XELOX or SOX regimen) and were categorized into responders and non-responders according to the RECIST 1.1 criteria. Baseline patient data and clinicopathological parameters related to gastric cancer were retrospectively collected. Serum levels of NGAL and G-CSFR were measured at three time points: before treatment (T0), after 2 cycles of therapy (T1), and after 4 cycles of therapy (T2). Differences in the dynamic changes of these biomarkers between groups were compared. Multivariate logistic regression analysis was performed to identify independent prognostic factors. ROC curves were constructed to evaluate the predictive performance of NGAL, G-CSFR, and their combined use for assessing the efficacy of trastuzumab-based targeted therapy in HER2-positive gastric cancer patients. Kaplan‑Meier analysis was used to assess the relationship between different NGAL and G‑CSFR levels and progression‑free survival (PFS). The proportions of TNM stage IV, HER2 FISH-positive status, and poorly differentiated pathological types were significantly higher in the non-responder group than in the responder group (P < 0.05). At T0, T1, and T2, serum NGAL levels were significantly higher in the non-responder group than in the responder group, and G-CSFR levels were significantly lower (P < 0.05). In both groups, NGAL levels progressively decreased over the treatment course, while G-CSFR levels progressively increased (P < 0.05). Multivariate logistic regression analysis identified poor differentiation and higher T0 NGAL levels as independent risk factors for non-response to trastuzumab-based targeted therapy in HER2-positive gastric cancer patients, while higher T0 G-CSFR levels served as an independent protective factor (P < 0.05). ROC curve analysis demonstrated that the combination of NGAL and G-CSFR at T0 yielded an AUC of 0.813 for predicting treatment response, which was significantly superior to that of either single marker (NGAL: 0.656; G-CSFR: 0.731). The combined assay achieved a sensitivity of 0.766 and a specificity of 0.751. Kaplan-Meier analysis showed that the high NGAL group had a median PFS of 6.0 (5.0, 9.0) months, significantly shorter than the low NGAL group with 7.0 (7.0, 11.0) months (Log-rank χ2 = 6.511, P = 0.011); the low G-CSFR group had a median PFS of 6.0 (5.0, 8.0) months, significantly shorter than the high G-CSFR group with 8.0 (8.0, 11.0) months (Log-rank χ2 = 15.968, P < 0.001). Baseline serum levels of NGAL and G-CSFR prior to treatment are closely associated with the efficacy of trastuzumab-based targeted therapy in patients with HER2-positive gastric cancer. The combination of these two biomarkers significantly improves the predictive performance for treatment response. Moreover, baseline NGAL and G-CSFR levels can effectively estimate patient PFS, suggesting their potential utility as non-invasive clinical biomarkers for predicting treatment efficacy and prognosis in HER2-positive gastric cancer patients receiving trastuzumab-based therapy.

PMID 42751472
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