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    DRUG:

    Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)

    i
    Other names: RG597 (SC formulation), trastuzumab SC, reformulated Herceptin
    Company:
    Halozyme, Roche
    Drug class:
    HER2 inhibitor
    Related drugs:
    10d
    A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN) (clinicaltrials.gov)
    P2, N=28, Active, not recruiting, Adrienne G. Waks | Recruiting --> Active, not recruiting | N=40 --> 28
    Enrollment closed • Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Trodelvy (sacituzumab govitecan-hziy) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    15d
    A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN) (clinicaltrials.gov)
    P2, N=40, Recruiting, Adrienne G. Waks | Trial primary completion date: Nov 2026 --> Feb 2026
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Trodelvy (sacituzumab govitecan-hziy) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    17d
    DS8201-801: Subcutaneous Trastuzumab Deruxtecan Phase 1 Trial. (2024-516625-31-00)
    P1, N=20, Recruiting, Daiichi Sankyo Inc.
    New P1 trial
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    1m
    Reducing treatment burden in HER2+ breast cancer: Evaluating subcutaneous injection methods for pertuzumab/trastuzumab combination therapy. (PubMed, Medicine (Baltimore))
    This retrospective analysis suggests that using a slow bolus injection with an infusion pump may reduce local adverse reactions following subcutaneous administration of pertuzumab and trastuzumab in patients with HER2-positive breast cancer. The standardized use of infusion pumps could enhance patient comfort, safety, and overall treatment experience.
    Observational data • Retrospective data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Perjeta (pertuzumab) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    1m
    Subcutaneous versus intravenous trastuzumab for HER2-positive breast cancer: a global systematic review and meta-analysis with a cost-minimization analysis from the Chinese healthcare system perspective. (PubMed, Front Pharmacol)
    These findings are particularly relevant to healthcare systems where SC formulations are newly introduced, providing timely evidence to guide patient-centered clinical decision-making. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=637674, identifier CRD42025637674.
    Retrospective data • Review • Journal • HEOR
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    2ms
    A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001) (clinicaltrials.gov)
    P2, N=66, Active, not recruiting, Pfizer | Trial completion date: Nov 2025 --> Jun 2026
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    capecitabine • Tukysa (tucatinib) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    2ms
    Efficacy and Safety of Subcutaneous Pertuzumab-Trastuzumab (Phesgo) in Neoadjuvant Treatment of HER2-positive Breast Cancer: Real-world Data from Japan. (PubMed, Anticancer Res)
    Phesgo demonstrated comparable or superior efficacy and favorable safety with markedly improved treatment efficiency in real-world Japanese practice. Phesgo represents a promising alternative to intravenous administration, reducing patient burden and optimizing healthcare resource utilization.
    Retrospective data • Journal • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive
    |
    Perjeta (pertuzumab) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    2ms
    A Phase 1 Comparative Study to Evaluate Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® After a Single 600 mg SC Injection in Healthy Male Volunteers (clinicaltrials.gov)
    P1, N=150, Not yet recruiting, Biocon Limited
    New P1 trial
    |
    Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    4ms
    A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants (clinicaltrials.gov)
    P1, N=312, Recruiting, Genentech, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    5ms
    A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants (clinicaltrials.gov)
    P1, N=312, Not yet recruiting, Genentech, Inc.
    New P1 trial
    |
    Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    5ms
    Thrombospondin-4 from Cancer-associated Fibroblasts Downregulates ERBB2 Expression in Gastric Cancer Cells. (PubMed, Carcinogenesis)
    The effects of Herceptin or gabapentin, a THBS4 receptor inhibitor, on subcutaneous tumors were examined in nude mice...In vivo, CAFs suppress HER2 expression of subcutaneous GC tumors and induce Herceptin resistance...THBS4 from CAFs downregulated HER2 (ERBB2) expression in GC cells. Thus, THBS4 receptor inhibitors may be useful in preventing the acquisition of resistance to anti-HER2 therapy.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • THBS4 (Thrombospondin 4)
    |
    HER-2 positive • HER-2 expression
    |
    Herceptin (trastuzumab) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    5ms
    Chimeric Receptor T Cells With Trastuzumab in HER2+ Advanced Breast Cancer and Other Solid Tumors (clinicaltrials.gov)
    P1/2, N=36, Not yet recruiting, National University Hospital, Singapore | Phase classification: P2 --> P1/2 | Trial primary completion date: Dec 2025 --> Dec 2026
    Phase classification • Trial primary completion date
    |
    HER-2 positive • HER-2 amplification
    |
    Herceptin (trastuzumab) • cyclophosphamide • fludarabine IV • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)