^
    1d
    HER2-CAR T Cells in Treating Patients With Recurrent Brain or Leptomeningeal Metastases (clinicaltrials.gov)
    P1, N=24, Active, not recruiting, City of Hope Medical Center | Trial completion date: Feb 2026 --> Jan 2027 | Trial primary completion date: Feb 2026 --> Jan 2027
    Trial completion date • Trial primary completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification
    |
    MB-103
    1d
    Optimize Neoadjuvant Therapy in HER2-Positive Early-Stage Breast Cancer (clinicaltrials.gov)
    P2, N=50, Recruiting, Rutgers, The State University of New Jersey | Not yet recruiting --> Recruiting
    Enrollment open • Biomarker assay • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • carboplatin • docetaxel • Perjeta (pertuzumab)
    1d
    CDKN1B inactivation impacts ER signaling and drives resistance to endocrine therapy in breast cancer. (PubMed, Br J Cancer)
    Our results highlight CDKN1B as a prognostic biomarker to guide CDK4/6-targeted therapy and a predictor of endocrine resistance in HR + /HER2- breast cancer.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • CDKN1B (Cyclin dependent kinase inhibitor 1B)
    |
    HR positive • HER-2 negative
    |
    tamoxifen • fulvestrant
    1d
    Targeting cyclin-dependent kinases in cancer: emerging therapeutics and clinical strategies. (PubMed, Trends Cancer)
    Several of these candidates have entered early-phase clinical evaluation, marking a new era in CDK-targeted therapy. This review synthesizes recent preclinical and clinical advances, defines key challenges in optimizing efficacy and safety, and outlines future directions for integrating CDK-directed strategies within precision oncology frameworks.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • EGFR positive
    1d
    ISG15 as a novel serum biomarker for breast Cancer: Diagnostic and prognostic significance, clinical laboratory applications, and multi-biomarker integration strategies. (PubMed, Clin Chim Acta)
    The enactment of ISG15 in clinical laboratory practices entails standardized assays, clearly defined decision limits, rigorous quality management, and prospective validation across diverse patient groups. Overall, serum ISG15 is a biologically feasible and analytically measurable candidate biomarker that meets the translational clinical chemistry objectives; however, its clinical implementation requires assay harmonization, outer validation, and incremental validation over the existing laboratory tests.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • CEACAM5 (CEA Cell Adhesion Molecule 5)
    1d
    Peripheral blood transcriptional profiling predicts tumor subtype and neoadjuvant chemoimmunotherapy outcomes in human breast cancer. (PubMed, Sci Transl Med)
    We developed a multiparametric peripheral immune biomarker that integrated baseline and early on-treatment features to predict response to pembrolizumab, which was successfully validated in an independent cohort of 59 patients with breast cancer treated with neoadjuvant dostarlimab. These findings reveal the potential of blood-based immune monitoring to predict immunotherapy benefit, offering an accessible tool for tailoring treatment strategies in breast cancer.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • Jemperli (dostarlimab-gxly)
    1d
    A multicenter, single-arm phase II clinical study of eribulin combined with inituzumab and pyrotinib in the treatment of HER2-positive advanced breast cancer (ChiCTR2600121825)
    P2, N=76, Recruiting, Fifth Affiliated Hospital, Sun Yat-Sen University; Fifth Affiliated Hospital, Sun Yat-Sen University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    Irene (pyrotinib) • Halaven (eribulin mesylate) • TheraCIM (nimotuzumab)
    1d
    Real-World Study of First-Line Treatment with Trastuzumab Biosimilar and Pertuzumab Biosimilar Combined with Chemotherapy in Patients with HER2-Positive Breast Cancer (ChiCTR2600121627)
    P=N/A, N=1500, Recruiting, The Second Qilu Hospital of Shandong University; The Second Qilu Hospital of Shandong University
    New trial • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification
    |
    Perjeta (pertuzumab)
    1d
    Demonstration Project on the Use of Trastuzumab for Injection in HER2-Positive Breast Cancer (ChiCTR2600121381)
    P=N/A, N=3245, Zhongshan Hospital Fudan University; Zhongshan Hospital Fudan University
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab)
    1d
    A single-arm, phase II, exploratory study of neoadjuvant treatment with Kudosil combined with Culmerciclib and dual-targeted therapy of trastuzumab and pertuzumab in HR+, HER2+ breast cancer (ChiCTR2600121242)
    P2, N=28, Recruiting, The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital); The First Affiliated Hospital of Nanjing Medical U
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • ER positive
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • letrozole • Saitanxin (culmerciclib)
    2d
    Trastuzumab and pertuzumab in combination with eribulin mesylate as neoadjuvant therapy for early or locally advanced HER2-positive breast cancer: a prospective, single-arm, phase II clinical trial (ChiCTR2600120346)
    P4, N=40, Recruiting, The First Hospital of Jilin University; The First Hospital of Jilin University
    New P4 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • HER-2 amplification • HER-2 expression
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • Halaven (eribulin mesylate)
    2d
    A Multicenter, Open-Label, Randomized, Phase II Clinical Trial of Trastuzumab Rezetecan-based Therapy for Brain Metastases in HER2-Positive Breast Cancer (ChiCTR2600120221)
    P2, N=108, ChongQing university cancer hospital; ChongQing university cancer hospital
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification
    |
    Herceptin (trastuzumab) • Focus V (anlotinib) • capecitabine • Irene (pyrotinib) • trastuzumab rezetecan (SHR-A1811)