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trastuzumab (HS 022 / HS022 / anruize)

✓ Approved

BioRay Pharmaceutical · ERBB2 · 单克隆抗体

什么是 trastuzumab？

trastuzumab 是一种单克隆抗体，由BioRay Pharmaceutical研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intravenous (IV)。

药物档案

商品名HS 022, HS022, anruize
公司BioRay Pharmaceutical
药物类别单克隆抗体, 抗体
分子靶点ERBB2
给药途径Injectable (Others), Intravenous (IV)
状态Approved
来源： ClinicalTrials.gov, BioRay Pharmaceutical

作用机制

分子靶点

trastuzumab 作用于 1 个分子靶点：

ERBB2erb-b2 receptor tyrosine kinase 2 (NEU, CD340)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

trastuzumab 针对 2 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Breast cancer✓ Approved
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Gastric cancer✓ Approved

相关研究文献

PubMedCureus2026-08-05

Identifying Predictors of Pathological Complete Response in Moroccan Patients With HER2-Positive Breast Cancer Treated With Neoadjuvant Therapy.

Atmane Boutaina B, El Afeya Jihad J, Toumi Safae S, Inrhaoun Hanane H et al.

Background The prognosis of human epidermal growth factor receptor 2 (HER2)-positive breast cancer has significantly improved with the use of neoadjuvant chemotherapy combined with anti-HER2 therapy. Achieving pathological complete response (pCR) is commonly associated with favorable long-term outcomes. However, real-world data on predictive factors influencing pCR remain limited, particularly in Morocco and North Africa, where evidence is scarce. Generating region-specific evidence is therefore essential to complement findings from other populations. This study aimed to assess pCR rates and identify predictors of response in Moroccan patients with HER2-positive breast cancer treated with neoadjuvant systemic therapy. Methods We retrospectively included 203 patients with stage I-III HER2-positive breast cancer treated with neoadjuvant chemotherapy plus trastuzumab, with or without pertuzumab, followed by surgery between October 2019 and April 2023. Predictors of pCR were assessed using logistic regression. Disease-free survival (DFS) was compared between patients achieving pCR and those without pCR using Cox proportional hazards regression analysis. Results Among 203 patients, 44.3% achieved pCR. Higher pCR rates were independently associated with hormone receptor-negative tumors (odds ratio (OR) = 2.20, 95% confidence interval (CI): 1.08-4.47), HER2 (score 3) status (OR = 4.80, 95% CI: 1.73-13.30), and the use of dual HER2 blockade (OR = 2.05, 95% CI: 1.03-4.07) compared with triple-positive tumors and HER2 (score 2) fluorescence in situ hybridization (FISH)-amplified tumors treated with trastuzumab alone. In contrast, lower pCR rates were observed in T3-T4 tumors (OR = 0.45, 95% CI: 0.23-0.92). After a median follow-up of 51.3 months, achieving pCR was significantly associated with improved DFS (HR = 0.07, 95% CI: 0.02-0.28; p < 0.001). Conclusions Tumor stage, hormone receptor status, HER2 expression, and neoadjuvant pertuzumab use were independently associated with pCR, emphasizing the importance of tailored neoadjuvant strategies in HER2-positive breast cancer.

PMID 42553770
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PubMedFuture oncology (London, England)2026-08-04

Clinical and genetic risk factors for anthracycline‑induced cardiotoxicity in Chinese early‑stage breast cancer patients: a candidate gene study.

Xu Shan S, Yang Hao H, Hu Nan N

This study aimed to clarify the incidence of anthracycline-induced cardiotoxicity (ACT) and identify its clinical and candidate genetic risk factors in Chinese early-stage breast cancer patients, so as to provide evidence for clinical risk assessment and individualized cardiac protection. This study included 119 patients who received anthracycline-based chemotherapy. Cardiac function was assessed via echocardiography at baseline, post-chemotherapy, and at one-year follow-up. Five candidate SNPs (CBR3 rs1056892, GSTP1 rs1695, SLC28A3 rs7853758, ABCB1 rs1045642, ABCC2 rs8187710) were genotyped to analyze their association with ACT. The incidence of ACT was 15.1% (18/119). No significant association was found between any of the five genotyped SNPs and the development of ACT (all p > 0.05). Multivariate logistic regression analysis identified older age, higher cumulative anthracycline dose, and the use of HER2-targeted antibodies (trastuzumab/pertuzumab) as independent clinical risk factors for ACT. In Chinese early-stage breast cancer patients, ACT is significantly associated with clinical risk factors rather than the selected candidate genetic polymorphisms. These findings support targeted cardiac monitoring and optimized treatment strategies for high-risk patients to reduce the occurrence of anthracycline-related cardiac injury.

PMID 42549829
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PubMedFrontiers in oncology2026-08-04

Association between HER2 expression, genomic characteristics, and tumor immune microenvironment dynamics in epithelial ovarian cancer.

Salinaro Julia J, De La Cruz Payton P, Perati Shriya S, McAdams Julia J et al.

Despite the rapid clinical approval of the HER2-directed antibody-drug conjugate trastuzumab deruxtecan (T-DXd) for patients with HER2-expressing epithelial ovarian cancer (EOC), preclinical mechanistic studies are lacking.The goal of this investigation was to determine the genomic and immunogenic characteristics associated with HER2 expressing EOC in order to better understand the mechanism of treatment response and what subset of patients will benefit most from single agent and combinatorial HER2-directed treatment regimens. 130 EOC patients were retrospectively identified from our institution's internal clinical genomic database. Selected genomic characteristics were stratified by gastric HER2 score and distributions were analyzed by Fisher's exact test. A subset of 34 EOC tumors were internally HER2 stained and fluorescent immunohistochemistry analysis of PD-L1, CD4, and CD8 was performed. EOC cell lines were treated with T-DXd and PD-L1 and VEGFA levels were assessed via quantitative PCR. VEGF expression following combinatorial T-DXd and bevacizumab treatment was determined via western blot. Non-significant differences were detected in HRD, CCNE1 amplification, and ARID1A status between HER2 high (n=29) and low (n=101) tumors in an EOC and high grade serous ovarian cancer (HGSOC) sub-cohort (n=98). Although not statistically significant, patients with HER2 high tumors had lower levels of FOLR1 positivity and higher levels of PD-L1 positivity in both EOC and HGSOC cohorts. Intratumoral PD-L1 expression and CD4+ T cell levels were significantly higher (p<0.05) in HER2 high tumors. Finally, T-DXd substantially downregulated PD-L1 and VEGFA expression, and bevacizumab and T-DXd synergistically reduced VEGF expression. HER2 high EOC tumors are more likely to be FOLR1 negative and PD-L1 positive, and treatment with T-DXd downregulates PDL-1 and VEGFA expression. These findings support further examination to determine if immunotherapy and anti-angiogenic treatments synergize with T-DXd in EOC.

PMID 42548619
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PubMedNigerian medical journal : journal of the Nigeria Medical Association2026-08-03

Neoadjuvant Chemotherapy Response in Breast Cancer among Nigerian Women: A Systematic Review and Meta-Analysis (2000-2025).

Muktar Umar U, Agbo Stephen P SP, Bashir Bello M BM, Sani Hamza H et al.

Neoadjuvant chemotherapy (NACT) is increasingly employed for locally advanced breast cancer in Nigeria, but treatment outcomes remain heterogeneous and often uncertain relative to global standards. We systematically reviewed Nigerian studies on NACT outcomes using PubMed, Embase, Scopus, Web of Science, AJOL, and grey literature through September 2025. Eligible studies included women receiving NACT who reported an objective response rate (ORR) or a pathologic complete response (pCR). Quality was assessed using ROBINS-I or RoB-2, and certainty was rated using GRADE. Pooled estimates were generated with random-effects (DerSimonian-Laird) models. Eleven studies (n = 629 women) met the inclusion criteria. Early anthracycline-based cohorts showed ORR = 51-93% with rare pCR. Contemporary anthracycline-taxane regimens achieved pCR ≈ 20%, the highest in HER2-positive and triple-negative disease. Pooled ORR = 66% (95% CI: 55-76%; I2= 46%) and pooled pCR = 20% (95% CI: 15-25%; I2= 39%). Excluding a non-standard single-agent trial raised pCR to 21%. The HER2-targeted ARETTA trial achieved pCR = 53%, approximating global benchmarks. Although one comparative study showed lower Nigerian pCR (5% vs 27% U.S.), survival appeared similar among patients completing multimodality therapy (observational finding). Certainty of evidence was rated low-to-moderate (GRADE). NACT in Nigeria achieves consistent clinical downstaging but modest pCR outside HER2-targeted settings. Expanding access to biomarker testing, taxanes, trastuzumab (including biosimilars), and ensuring therapy completion are essential to close the global outcome gap.

PMID 42544249
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PubMedGastroenterology report2026-08-02

Tumor-microenvironment-mediated immune escape drives trastuzumab resistance in HER2-positive gastric cancer.

Lv Huifang H, Zhao Wanying W, Wang Sai-Qi SQ, He Yunduan Y et al.

The combination of trastuzumab and chemotherapy, with or without pembrolizumab, is the current first-line standard of care for patients with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer and gastroesophageal junction cancer. However, upon disease progression, subsequent therapies often yield limited clinical benefit. The mechanisms of drug resistance to trastuzumab remain unresolved. Current studies on its resistance mechanisms have largely focused on alterations in the HER2 pathway, including HER2 heterogeneity, reduced or absent HER2 expression, variations in HER2 dimerization, and mutations in downstream components, among others. Crucially, as a monoclonal antibody, the antitumor activity of trastuzumab is partially mediated by the immune system, yet the immunology-related mechanisms of resistance are frequently overlooked. In this review, we systematically analyse the outcomes of both successful and failed clinical trials of anti-HER2 agents to propose that immune escape within the tumor microenvironment is a key driver of trastuzumab resistance in HER2-positive gastric cancer.

PMID 42542713
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PubMedEClinicalMedicine2026-08-02

Postmastectomy radiation therapy in patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer: a retrospective exploratory cohort analysis of the adjuvant lapatinib and/or trastuzumab treatment optimization (ALTTO) trial [BIG 2-06/NCCTG N063D (Alliance)].

De Santis Maria Carmen MC, Campbell Christine C, Samy Faye F, De Rose Fiorenza F et al.

Postmastectomy radiation therapy (PMRT) improves locoregional control and survival in patients with early breast cancer, but it is unclear whether these benefits extend to human epidermal growth factor receptor 2 (HER2)-positive patients in the anti-HER2 era. This was a retrospective cohort analysis of prospectively collected data from the phase III ALTTO trial and includes all ALTTO participants who underwent mastectomy regardless of randomisation arm. The phase III ALTTO trial enrolled patients between 2007 and 2011 from 946 centers from 44 countries in four different continents. Eligible patients had histologically confirmed HER2-positive breast cancer with either node-positive disease or node-negative disease with pathologic tumour size ≥1 cm. PMRT was non-randomised and delivered at the investigator's discretion. Primary efficacy analyses were conducted in the intention-to-treat population; safety analyses included all patients who received at least 1 dose of anti-HER2 therapy. Endpoints were locoregional recurrence (LRR), distant recurrence (TTDR), disease-free (DFS), and overall survival (OS). DFS and OS were analysed using Cox models; LRR and TTDR competing risk models. All models included the interaction between number of metastatic nodes, 0 (pN0), 1-3 (pN1) or ≥4 (pN2) and PMRT. Multivariable models accounted for patient and tumour characteristics. Hazard ratios (HR) and their 95% confidence interval (CI) are reported. Overall, 4154 patients treated with mastectomy were analysed: 1987 (47.8%) with and 2167 (52.2%) without PMRT. Baseline characteristics were worse in the PMRT group, whereas adjuvant endocrine and chemotherapy use/type was similar between groups. At a median follow-up of 9.2 years (IQR, 6.4-10), 129 LRR events occurred: 43 (2.2%) in the PMRT group and 86 (4.0%) in the no-PMRT group. In patients with pN2, PMRT was associated with improved LRR control (HR 0.31; 95% CI 0.16-0.59), TTDR (HR 0.59; 95% CI 0.44-0.79), DFS (HR 0.58; 95% CI 0.45-0.75), and OS (HR 0.61; 95% CI 0.44-0.86). In patients with pN1, PMRT showed marginal benefit in DFS (HR 0.82; 95% CI 0.64-1.05) but not in LRR (HR not calculated), TTDR (HR 0.89; 95% CI 0.65-1.23), nor OS (HR 0.88; 95% CI 0.62-1.24). Only 229 (15%) patients with pN0 received PMRT, with no evidence of benefit in any endpoints. In this large HER2-positive, predominantly node-positive, adjuvant cohort, PMRT improved locoregional control and conferred a clinically meaningful survival benefit in pN2. In the landscape of personalized treatment and growing interest in axillary de-escalation, future prospective studies are warranted to better define which HER2-positive patients with low nodal burden (particularly pN1 disease) derive meaningful benefit from PMRT in the context of modern systemic therapy. The publication of this analysis was funded by the Italian Ministry of Health through Ricerca Corrente funds.

PMID 42541182
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