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    DRUG CLASS:

    HER2-targeted antibody-drug conjugate

    Related drugs:
    2d
    DESTINY-Breast08: A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=138, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2025 --> Jun 2026
    Trial completion date
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    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
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    HER-2 expression • HER-2 underexpression • PGR positive
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    Imfinzi (durvalumab) • paclitaxel • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • fulvestrant • Truqap (capivasertib) • anastrozole
    3d
    Sequencing antibody-drug conjugates in metastatic breast cancer: A systematic review. (PubMed, Cancer Treat Rev)
    Emerging evidence indicates that sequential ADC use can be effective despite some cross-resistance, especially when distinct payload mechanisms are employed. Clinical use should consider payload type, timing, and breast cancer subtype, but toxicities remain critical for decision-making. Research providing insights into resistance mechanisms and biomarkers is needed for personalized approaches.
    Review • Journal
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 positive • HER-2 negative
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    Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki)
    4d
    A Phase II Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics/Pharmacodynamics of JSKN033 in Patients With Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=160, Not yet recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd
    New P2 trial
    4d
    Traderrus: A Study to Assess the Efficiency of Trastuzumab Deruxtecan in Russian Breast Cancer Patients (clinicaltrials.gov)
    P=N/A, N=60, Recruiting, Blokhin's Russian Cancer Research Center
    New trial
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki)
    4d
    A Clinical Study of the Efficacy and Safety of Disitamab Vedotin in Combination With Radiotherapy for the Adjuvant Treatment of HER2 Overexpressing UTUC Patients With High Risk Factors for Recurrence After Radical Surgery (clinicaltrials.gov)
    P2, N=60, Recruiting, Peking University First Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Aidixi (disitamab vedotin)
    4d
    A Study of SHR-A1811 Combined With Adebelimumab as Neoadjuvant Therapy for Resectable HER2-Altered Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Shanghai Chest Hospital
    New P2 trial
    |
    trastuzumab rezetecan (SHR-A1811) • AiRuiLi (adebrelimab)
    4d
    Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer (clinicaltrials.gov)
    P1, N=36, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Dec 2025 --> Mar 2026
    Trial initiation date
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • pidnarulex (CX-5461)
    5d
    A Comprehensive Analysis of HER2 status Heterogeneity Using Matched Samples among Potential Beneficiaries of Trastuzumab Deruxtecan Therapy in Non-Small Cell Lung Cancer. (PubMed, Clin Lung Cancer)
    Our study demonstrates that in potential NSCLC beneficiaries of T-DXd therapy, HER2 expression is underestimated in biopsy samples and metastatic lesions compared to resected and primary sites. This heterogeneity holds great significance for guiding clinical sample selection.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki)
    6d
    A Phase II Study of Toripalimab Plus RC48-ADC With Radiotherapy for Bladder Preservation in HER2-Positive Muscle-Invasive Bladder Cancer (clinicaltrials.gov)
    P2, N=45, Not yet recruiting, Tongji Hospital
    New P2 trial
    |
    cisplatin • Loqtorzi (toripalimab-tpzi) • Aidixi (disitamab vedotin)
    6d
    Endometrial Carcinomas - Challenges and Updates on Selected Topics. (PubMed, Hum Pathol)
    Across these variants, integration of morphology with targeted immunohistochemistry and molecular testing (including p53, MMR status, POLE) is essential for accurate classification, risk stratification. HER2 overexpression and/or amplification occurs in 25-30% and HER2 testing has become a standard biomarker for selecting patients with recurrent or advanced disease for trastuzumab, and more recently trastuzumab-deruxtecan therapy.
    Review • Journal
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    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CTNNB1 (Catenin (cadherin-associated protein), beta 1)
    |
    HER-2 overexpression • HER-2 amplification • ER negative
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki)
    8d
    Effusion Reduction after Early Trastuzumab Deruxtecan Therapy for Unresectable HER2-Low Breast Cancer in an Older Patient: A Case Report. (PubMed, Surg Case Rep)
    T-DXd is potentially a safe and effective treatment option for older patients with HER2-low breast cancer and for those with impaired ADL. Further accumulation of cases and investigations of long-term outcomes are warranted.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki)
    9d
    High-Risk Node-Positive Hormone Receptor-Positive/HER2-Low Breast Cancer Relapse on Adjuvant Abemaciclib Treatment with ER Loss at Metastatic Recurrence: A Case Report and Literature Review. (PubMed, Diagnostics (Basel))
    Conversely, T-DXd administered due to the presence of HER2-low showed excellent effectiveness. Performing a re-biopsy is crucial due to the possible loss of estrogen receptors, which would require a change in therapeutic strategy no longer based on endocrine therapy. In cases that remain luminal, knowledge of the mutational profile may help to offer patients novel targeted treatments.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • RB1 (RB Transcriptional Corepressor 1)
    |
    HER-2 positive • HR positive • HER-2 negative • RB1 mutation • ESR1 mutation
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Verzenio (abemaciclib)