^
    18h
    Stage I Triple-Negative Breast Cancer: Moving From One-Size-Fits-All to a Personalized Approach. (PubMed, Am Soc Clin Oncol Educ Book)
    Currently, the primary factor influencing systemic therapy decisions is the anatomic stage, without other biomarkers clinically used to guide systemic therapy. This review summarizes the existing evidence supporting current and emerging systemic therapy strategies for stage I TNBC, with a special focus on treatment de-escalation and promising biomarkers that can advance personalized treatment selection.
    Clinical • Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • EGF (Epidermal growth factor)
    |
    HER-2 amplification
    1d
    Artificial intelligence enhances cancer cell selection for HER2 gene amplification assessment in breast carcinoma. (PubMed, Virchows Arch)
    Discordant cases required the selection of a second cancer cell-enriched region of interest, shifting classification from HER2-negative to HER2-positive. After correction, IA 2.0 achieved full agreement with visual classification (100%, k = 1.000), underscoring the critical role of the pathologist supervision in this assay.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification • HER-2 negative
    1d
    Immunotherapy and Targeted Therapy for Advanced Biliary Tract Cancer (PubMed, Korean J Gastroenterol)
    Systemic chemotherapy with gemcitabine plus cisplatin has remained the standard first-line treatment for more than a decade because most patients are diagnosed at an advanced or unresectable stage, but the associated survival benefit is limited. Accordingly, optimizing patient selection by integrating molecular and immunologic characteristics has become a critical objective for improving clinical outcomes. This review provides an overview of the recent progress in immunotherapy and targeted therapy for BTC, focusing on pivotal clinical trials, therapeutic efficacy, current limitations, and future perspectives for personalized treatment strategies.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • PD-1 (Programmed cell death 1)
    |
    EGFR mutation • HER-2 amplification • IDH1 mutation • FGFR2 mutation • FGFR2 fusion
    |
    cisplatin • gemcitabine
    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
    2d
    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)
    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)
    2d
    Transformation to the TCbHPy regimen for early or locally advanced HR-/HER2+ breast cancer patients insensitive to 2 cycles of TCbHP neoadjuvant therapy：A prospective, exploratory, phase II, multicenter study (ChiCTR2600119838)
    P2, N=171, Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University); Jiangsu Province Hospital (The First Affiliated Hospital wi
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification
    3d
    Amivantamab Monotherapy in Chemorefractory RAS/BRAF Wild-Type Metastatic Colorectal Cancer: Results From OrigAMI-1, an Open-Label, Phase Ib/II Study. (PubMed, J Clin Oncol)
    Amivantamab monotherapy demonstrated promising, durable antitumor activity in chemorefractory mCRC, regardless of prior anti-EGFR therapy and the primary tumor location. The amivantamab safety profile in mCRC is consistent with experience in NSCLC. Amivantamab plus chemotherapy is currently being explored in two phase III studies in first-line and second-line mCRCs.
    P1/2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene)
    |
    HER-2 amplification • BRAF wild-type
    |
    Avastin (bevacizumab) • Rybrevant (amivantamab-vmjw)
    4d
    PERTUREAL: Real-world Bicohort Observational Study of a Pertuzumab Biosimilar in the Treatment of Breast Cancer: in the Neoadjuvant Setting and in First-line Metastatic Disease (clinicaltrials.gov)
    P=N/A, N=1000, Recruiting, Société Algérienne de Formation et Recherche en Oncologie
    New trial • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification
    |
    Perjeta (pertuzumab)
    5d
    A Real-World Study on the Impact of Different Adjuvant Treatment Regimens on Prognosis in Non-pCR Patients With HER2-Positive Breast Cancer After Neoadjuvant Therapy (clinicaltrials.gov)
    P=N/A, N=2000, Not yet recruiting, Hebei Medical University Fourth Hospital
    New trial • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification
    |
    Perjeta (pertuzumab)
    5d
    Durvalumab With Trastuzumab and Pertuzumab in HER2-Enriched Breast Cancer (clinicaltrials.gov)
    P2, N=51, Active, not recruiting, The Methodist Hospital Research Institute | N=39 --> 51 | Trial completion date: Dec 2025 --> Dec 2028
    Enrollment change • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 amplification • PD-L1 negative
    |
    BluePrint
    |
    Herceptin (trastuzumab) • Imfinzi (durvalumab) • Perjeta (pertuzumab)