Drug Database
TR

trastuzumab (Vivitra)

✓ Approved

Ligand Pharmaceuticals · ERBB2 · Monoclonal Antibodies

What is trastuzumab?

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

Drug Profile

Brand NamesVivitra
CompanyLigand Pharmaceuticals
Drug ClassMonoclonal Antibodies, Antibody
Molecular TargetERBB2
RouteInjectable (Others), Intravenous (IV)
StatusApproved
Sources: ClinicalTrials.gov, Ligand Pharmaceuticals

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 1 unique indication across 1 therapeutic area.

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

Related Research Articles

PubMedBioconjugate chemistry2026-10-22

Comparison of an Fcab-Drug Conjugate with Other Antibody-Drug Conjugate Formats towards Exposure and Antitumor Activity.

Jäger Sebastian S, Piater Birgit B, Dickgiesser Stephan S, Tonillo Jason J et al.

Antibody-drug conjugates (ADCs) based on Fc antigen-binding fragments (Fcabs) promise improved tumor penetration while retaining the FcRn-mediated long half-life. Building on prior spheroid studies, we directly compared a 50 kDa HER2-targeted Fcab-MMAE ADC with a matched 150 kDa control molecule (aDIG-Fcab-MMAE) consisting of the same HER2-targeting Fcab ADC equipped with additional non-targeting anti-digoxigenin (aDIG) Fab arms and trastuzumab Fab- and IgG-based ADCs (50 kDa T-Fab-MMAE and 150 kDa T-IgG-MMAE) using the same linker-payloads. Site-specific conjugation yielded high-purity DAR2 species with excellent serum stability. In vitro cytotoxicity assays revealed that Fcab-MMAE and aDIG-Fcab-MMAE exhibited lower potency compared to T-Fab-MMAE and T-IgG-MMAE, correlating with their approximately 10-fold lower binding affinity for HER2. A pharmacokinetic study in mice showed similar exposure for the Fcab-MMAE, its 150 kDa control, and a higher exposure for T-IgG-MMAE ADC, while the T-Fab-MMAE ADC cleared rapidly. In an NCI-N87 gastric cancer SCID mouse xenograft model, T-IgG-MMAE demonstrated superior efficacy, while Fcab-MMAE and aDIG-Fcab-MMAE showed similar efficacy despite their size difference, with T-Fab-MMAE showing lower efficacy. These data indicate that at similar exposure, reduced scaffold size alone may not improve in vivo efficacy.

PMID 42902947
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PubMedThe Journal of the Association of Physicians of India2026-10-22

Real-world Outcomes of Neoadjuvant Dual HER2 Blockade with TCHP in Early and Locally Advanced HER2-Enriched Breast Cancer: Experience from a South Indian Tertiary Oncology Center.

Potu Sanjana Reddy SR, Gumdal Vishesh V, Koppaka Deepak D, Natti Hema Sireesha HS et al.

HER2-enriched breast carcinomas are biologically aggressive but highly responsive to targeted therapy. Data on the real-world effectiveness of neoadjuvant docetaxel, carboplatin, trastuzumab, and pertuzumab (TCHP) from Indian oncology practices remain sparse. To assess pathological complete response (pCR), treatment-related toxicities (CTCAE v5.0), and survival outcomes among patients with nonmetastatic HER2-positive breast cancer receiving neoadjuvant TCHP. A bidirectional observational analysis was conducted on 55 patients with HER2-positive nonmetastatic breast carcinoma who were treated at a tertiary oncology center. Patients received neoadjuvant TCHP followed by definitive surgery. Clinical response, radiological response, pCR, treatment compliance, toxicity, disease-free survival (DFS), and overall survival (OS) were evaluated. Statistical associations with pCR were analyzed using Fisher's exact test. The median age of the patients was 47 years. Stage III disease was the most common (70.9%). Hormone receptor negativity was observed in 56% of the patients. Clinical complete response was achieved in 85% of the patients, whereas radiological complete remission occurred in 58%. A pCR was documented in 60% of the cohort. A significant correlation with pCR was observed for clinical response (p < 0.001), radiological response (p = 0.002), and uninterrupted treatment completion within 18 weeks (p = 0.013). Hormone receptor expression and baseline stage did not significantly influence pCR rates. Diarrhea and neutropenia were the predominant toxicities, whereas clinically relevant cardiotoxicity was not encountered. At a median follow-up of 29 months, the estimated 3-year DFS and OS were 95% and 97.2%, respectively. Neoadjuvant TCHP demonstrated substantial pathological response rates, acceptable tolerability, and encouraging survival outcomes in HER2-positive breast cancer. Adherence to the planned treatment timeline significantly influenced therapeutic efficacy.

PMID 42902661
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PubMedFrontiers in oncology2026-10-22

Complications of clozapine cessation in the context of chemotherapy-related neutropenia-a case report.

Sweeney Colm C, Rush Gavin G, O'Dwyer Sarah S, Mac Eochagain Colm C et al.

Clozapine is the gold standard for treatment-resistant schizophrenia (TRS). It requires strict monitoring of full blood count (FBC), due to the risk of neutropenia and agranulocytosis. AB is a woman in her mid-40s with TRS, diagnosed with invasive ductal carcinoma of the right breast. She was commenced on a chemotherapy regimen of docetaxel, carboplatin, trastuzumab, and pertuzumab. Four days after the initial infusion, AB developed neutropenia with an absolute neutrophil count of 0.2 × 109/L. In accordance with local protocols and discussion with the Clozapine Patient Monitoring Service (CPMS), clozapine was immediately discontinued. Two weeks after clozapine cessation, AB displayed catatonic symptoms characterised by mutism, posturing, and automatic obedience, scoring 27 on the Bush-Francis Catatonia Rating Scale (BFCRS). A positive lorazepam challenge confirmed the diagnosis of clozapine-withdrawal catatonia. Despite regular high-dose benzodiazepines and treatment with antipsychotics, AB's presentation continued to deteriorate, characterised by prominent delusions and hallucinations, impeding oncological treatment. AB was seen extensively by liaison psychiatry and treated with high-dose typical and atypical antipsychotics; however, she failed to respond adequately to treatment. Given AB's extensive previous history of management on clozapine without previous haematological disturbance and ongoing decline in mental state, coupled with the timeline of symptoms 4 days after the administration of chemotherapy agents associated with neutropenia, namely, carboplatin, the decision was taken to reinstate clozapine. Following titration of clozapine and transfer to a specialist psychiatric unit, AB's symptoms resolved rapidly, allowing for the successful completion of chemotherapy. Carboplatin was omitted in subsequent cycles, with no further episodes of neutropenia. This case highlights the diagnostic challenge of neutropenia in psychiatric patients on clozapine, who are also undergoing treatment for comorbid medical conditions. The presence of neutropenia in clozapine patients may lead to diagnostic overshadowing and delay the diagnosis of the underlying cause of neutropenia, resulting in delays to treatment as well as unnecessary cessation of clozapine and risk of relapse. Furthermore, this case highlights the risk of catatonia associated with the withdrawal of clozapine and the importance of its rapid identification and management. Clinicians should consider differing aetiologies of neutropenia in clozapine patients, especially those undergoing chemotherapy. Furthermore, clinicians should be skilled in recognising catatonia and initiating prompt treatment.

PMID 42903121
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PubMedCase reports in women's health2026-10-20

Advanced vulvar adenocarcinoma of mammary gland type: a case report.

Levin Lane L, Reeson Monica M, Hoekstra Anna A

Vulvar adenocarcinoma of mammary gland type (AMGT) is a rare, locally aggressive neoplasm of anogenital mammary-like glands that mimics the histologic and immunophenotypic features of breast carcinoma. Fewer than 60 cases have been described in the literature since the first documented case in 1936. The extreme rarity and resemblance to breast carcinoma complicate diagnosis and treatment. This report presents a case of AMGT in a 61-year-old woman who presented with a palpable, subcutaneous lesion of the lateral mons pubis and labia minora. Initial biopsy identified the lesion as metastatic carcinoma, but immunohistochemical (IHC) analysis and PET/CT indicated a vulvar adenocarcinoma with local nodal metastasis. Aggressive management with radical vulvectomy and bilateral inguinofemoral lymphadenectomy with thorough specimen evaluation by surgical pathology led to the final diagnosis of AMGT TNM stage pT1bpN2cM0 and vulvar FIGO Stage IIIC. IHC staining identified the tumor as ER, PR, and 3+ HER2 positive. Breast cancer treatment guidelines informed the ultimate systemic therapy regimen of docetaxel, carboplatin, trastuzumab, and pertuzumab. Maintenance therapy with trastuzumab and anastrozole was utilized. The patient remained in remission from AMGT 24 months following completion of chemotherapy. While the diagnosis of AMGT poses a unique challenge, IHC staining and imaging to rule out metastatic carcinoma can support the ultimate diagnosis. The sustained remission in this case supports the extrapolation of treatment from vulvar and breast cancer guidelines. Additionally, this case suggests the utility of hormone receptor- and HER2-targeted therapies for systemic treatment.

PMID 42898055
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PubMedThe oncologist2026-10-20

Equivocal and Definite Interstitial Lung Abnormalities as Risk Factors for Trastuzumab Deruxtecan-Related Interstitial Lung Disease in Breast Cancer.

Nakamura Tomoaki T, Murata Naoki N, Hibino Yukiko Y, So Clara C et al.

Trastuzumab deruxtecan (T-DXd) is effective for advanced breast cancer but is associated with interstitial lung disease (ILD). The clinical relevance of baseline interstitial lung abnormalities (ILAs), including subtle equivocal findings, remains unclear. This retrospective cohort study included consecutive patients with advanced or recurrent breast cancer who initiated T-DXd at a tertiary hospital in Japan between June 2020 and May 2025. Baseline CT before T-DXd initiation was reviewed for ILAs and classified as no ILA, equivocal ILA, or definite ILA. The cumulative incidence of T-DXd-related ILD was estimated using a competing-risk approach. Among 156 patients, baseline ILAs were identified in 50 patients: 21 with equivocal ILA and 29 with definite ILA. T-DXd-related ILD occurred in 31 patients (20%), including 19 of 50 patients (38%) in the ILA group and 12 of 106 patients (11%) in the non-ILA group. Baseline ILA was associated with a higher cumulative incidence of T-DXd-related ILD (subdistribution hazard ratio, 3.56; 95% CI, 1.63-7.78; p = 0.001). No significant difference in T-DXd-related ILD risk was detected between the equivocal and definite ILA groups. This association remained consistent in the <1.5-mm CT subgroup. No significant differences in progression-free or overall survival were observed according to baseline ILA status. Among patients with baseline ILA, 33 of 50 had ILAs first detected during prior systemic anticancer therapy. Baseline ILAs, including equivocal findings, were associated with an increased risk of T-DXd-related ILD. ILAs were frequently first detected during prior systemic anticancer therapy before T-DXd initiation.

PMID 42897999
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PubMedESMO open2026-10-20

Germline pharmacogenetic variants associated with trastuzumab deruxtecan-induced interstitial lung disease in advanced breast cancer: PROCURE project.

Arenas A A, Saura C C, Alva-Bianchi M M, de Nicolás-Hernández J J et al.

Trastuzumab deruxtecan (T-DXd) has demonstrated substantial clinical benefit in patients with advanced human epidermal growth factor receptor 2 (HER2)-positive and HER2-low breast cancer. However, treatment-related adverse events-particularly interstitial lung disease (ILD) or pneumonitis-represent a clinically relevant limitation. While UGT1A1 polymorphisms influence toxicity with other topoisomerase I inhibitor-based therapies, their role in T-DXd-related toxicity appears limited. The PROCURE project aimed to investigate germline pharmacogenetic variants beyond UGT1A1 associated with T-DXd-induced ILD. The PROCURE project is a multicenter translational study conducted across 26 Spanish institutions. Germline DNA from patients with advanced HER2-positive or HER2-low breast cancer treated with T-DXd was genotyped using the Infinium Global Diversity Array enriched for pharmacogenomic variants. A candidate gene approach was applied to 14 genes involved in drug metabolism, transport, pharmacodynamics, and immune-mediated drug hypersensitivity. Logistic regression models were used to evaluate associations with ILD/pneumonitis. A total of 290 patients with clinical and genotyping data were included in the analysis. The median age was 58 years (range, 34-94 years). After a median follow-up of 18.3 months [95% confidence interval (CI): 15.4-20.5], the cohort registered 33 ILD cases (incidence of 11.4%). The strongest association signals mapped to variants within the human leukocyte antigen (HLA) region, with the top single nucleotide polymorphism near HLA-F (rs9258213; OR 6.8, 95% CI 2.6-17.9, P = 9.5 × 10-5). Additional associations were observed in SLCO1B1 and CYP3A4, genes involved in T-DXd transport and metabolism. This study identifies host genetic variation within the HLA locus and drug pharmacokinetic pathways as potential contributors to T-DXd-induced ILD in patients with advanced breast cancer. Although no definitive pharmacogenomic predictor was identified, these findings provide insights into the biological mechanisms underlying this toxicity and support further investigation of pharmacogenomic biomarkers to improve risk stratification and guide personalized T-DXd therapy.

PMID 42901050
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