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    BIOMARKER:

    HER-2 negative

    i
    Other names: ERBB2, CD340, HER-2, HER2, NEU, NGL, V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2
    Entrez ID:
    2064
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    Related tests:
    19h
    EPIK-B6: Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=24, Active, not recruiting, Novartis Pharmaceuticals | Trial primary completion date: Jan 2025 --> Jul 2025
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant
    19h
    Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=35, Completed, Vanderbilt-Ingram Cancer Center | Active, not recruiting --> Completed | Trial completion date: Sep 2024 --> Mar 2024
    Trial completion • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • FGFR2 (Fibroblast growth factor receptor 2) • FGFR1 (Fibroblast growth factor receptor 1) • FGFR4 (Fibroblast growth factor receptor 4) • FGF23 (Fibroblast Growth Factor 23)
    |
    HER-2 negative • FGFR1 amplification • FGFR3 amplification • FGFR4 amplification • FGFR amplification
    |
    Ibrance (palbociclib) • Balversa (erdafitinib) • fulvestrant
    20h
    Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=69, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Feb 2025 --> Aug 2025
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant
    21h
    FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=64, Recruiting, Regor Pharmaceuticals Inc. | N=18 --> 64
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CDK4 (Cyclin-dependent kinase 4)
    |
    HER-2 negative • PIK3CA mutation
    |
    RGT-419B
    1d
    Validating the APIS Breast Cancer Subtyping Kit: mRNA Expression of ER, PR, HER2, and Ki67 Compared to Immunohistochemistry in 374 Breast Cancer Core Needle Biopsies (AMP 2024)
    A high level of agreement between IHC/ISH and mRNA expression determined by the APIS kit was observed for all markers. Subtype call agreement improved when Ki67 status was excluded, likely due to the challenges in distinguishing high and low Ki67 expression with IHC, leading to ambiguity in differentiating luminal B HER2- from luminal A tumours. Molecular subtyping offers additional insights for guiding breast cancer management decisions.
    Biopsy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 amplification • HER-2 negative • HER-2 expression • KIT expression • PGR expression
    |
    APIS Breast Cancer Subtyping Kit
    1d
    Frequency of FDA-Approved Companion Diagnostic Biomarkers in Solid Tumors (AMP 2024)
    Genomic profiling yields clinically actionable information for approved therapies and evidence of resistance, and it may uncover rational therapeutic opportunities regardless of tumor type.
    Tumor mutational burden • Companion diagnostic • BRCA Biomarker • MSi-H Biomarker • BRCA Companion diagnostic • MSi-H Companion diagnostic
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • RET (Ret Proto-Oncogene) • PTEN (Phosphatase and tensin homolog) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • AKT1 (V-akt murine thymoma viral oncogene homolog 1)
    |
    BRAF V600E • KRAS mutation • BRCA2 mutation • TMB-H • MSI-H/dMMR • KRAS G12C • HER-2 negative • PIK3CA mutation • BRAF V600 • NTRK1 fusion • NTRK3 fusion • NTRK2 fusion • RET fusion • ROS1 fusion • KRAS G12 • KRAS exon 2 mutation • ALK-ROS1 fusion
    |
    OncoExTra™ test
    1d
    A Study to Learn About the Vepdegestrant (ARV-471, PF-07850327) in People With ER+/HER2- Locally Advanced or Metastatic Breast Cancer (BC) (clinicaltrials.gov)
    P1, N=6, Active, not recruiting, Pfizer | Trial completion date: Sep 2024 --> Mar 2025
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    vepdegestrant (ARV-471)
    2d
    Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49) (clinicaltrials.gov)
    P3, N=340, Active, not recruiting, Merck Sharp & Dohme LLC | N=800 --> 340 | Trial completion date: Jul 2028 --> Mar 2025 | Trial primary completion date: Jul 2028 --> Mar 2025
    Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • paclitaxel • capecitabine • albumin-bound paclitaxel • pegylated liposomal doxorubicin
    2d
    SGNB7H4V-001: A Study of SGN-B7H4V in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=572, Recruiting, Seagen Inc. | N=430 --> 572 | Trial completion date: Jan 2027 --> Nov 2027 | Trial primary completion date: Jun 2025 --> Nov 2027
    Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative • PTEN mutation + HR positive
    |
    Keytruda (pembrolizumab) • felmetatug vedotin (PF-08046048)
    2d
    NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III) (clinicaltrials.gov)
    P2, N=348, Recruiting, West German Study Group | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 negative • PGR negative
    |
    Keytruda (pembrolizumab) • Trodelvy (sacituzumab govitecan-hziy)
    2d
    ADAPTcycle: Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC (clinicaltrials.gov)
    P3, N=1684, Active, not recruiting, West German Study Group | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive • HER-2 negative + PGR positive
    |
    Kisqali (ribociclib)
    5d
    Predicting treatment response to immunotherapy combined with chemotherapy in advanced gastric/gastroesophageal junction cancer based on the multi-omics information during tumor evolution (ChiCTR2400089955)
    P=N/A, N=150, Not yet recruiting, Zhejiang Cancer Hospital; Zhejiang Cancer Hospital
    New trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    5d
    The efficacy and safety of irinotecan liposome injection combined with cadunilumab in the second-line treatment of patients with locally advanced or metastatic gastric adenocarcinoma (ChiCTR2400090935)
    P4, N=30, Recruiting, Jiangsu Cancer Hospital; Jiangsu Cancer Hospital
    New P4 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    5d
    A Prospective, Multicenter Clinical Study of the Efficacy and Safety of First-Line Treatment with Ivonescimab in Combination with XELOX for Unresectable Advanced Gastric/Gastroesophageal Junction Adenocarcinoma (ChiCTR2400089954)
    P2, N=30, Not yet recruiting, Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine; Renji Hospital affiliated to Shanghai Jiaotong University School of Medi
    New P2 trial • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    capecitabine • oxaliplatin • Yidafan (ivonescimab)
    5d
    The role of low-dose radiotherapy in maintenance therapy after first-line treatment of HER2-negative advanced gastric cancer (ChiCTR2400089076)
    P2, N=80, Not yet recruiting, Sichuan Mianyang 404 Hospital; Sichuan Mianyang 404 Hospital
    New P2 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative • HER-2 expression
    |
    capecitabine • oxaliplatin
    5d
    A single-arm, single-center clinical study of chidamide in combination with vinorelbine and capecitabine in the treatment of HER2-negative advanced breast cancer (ChiCTR2400090102)
    P2, N=26, Not yet recruiting, ChongQing university cancer hospital; ChongQing university cancer hospital
    New P2 trial • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    capecitabine • vinorelbine tartrate • Epidaza (chidamide)
    5d
    Neoadjuvant endocrine therapy for breast cancer (ChiCTR2400088944)
    P2, N=60, Recruiting, The First Affiliated Hospital of Xi'an Jiaotong University; The First Affiliated Hospital of Xi'an Jiaotong University
    New P2 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HR positive • HER-2 negative • HER-2 expression • PGR positive • PTEN mutation + HR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive • HER-2 negative + PGR positive
    5d
    A Multicenter, Open-label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Subjects With Locally Advanced or Metastatic Breast Cancer Who Are TNBC and HR Positive, HER2 Zero, or HER2 Hypoactive (ChiCTR2400089158)
    P2, N=180, Recruiting, Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center
    New P2 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HR positive • HER-2 negative • HER-2 expression • HER-2 underexpression • PGR expression • HER-2 negative + HR negative
    |
    BNT326
    5d
    Dalcilib combined with aromatase inhibitors and capecitabine neoadjuvant therapy Open, single arm, multi arm treatment of HR positive/HER2 negative early breast cancer Central research (ChiCTR2400090076)
    P2, N=30, Not yet recruiting, Fujian Medical University Affiliated Union Hospital; Fujian Medical University Affiliated Union Hospital
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • HER-2 expression • PGR expression
    |
    capecitabine
    5d
    A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BGB-C354, an Antibody-Drug Conjugate Targeting B7H3, Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors (ChiCTR2400091198)
    P1, N=92, Not yet recruiting, Jilin Cancer Hospital; Jilin Cancer Hospital
    New P1 trial • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CD276 (CD276 Molecule) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    EGFR mutation • HER-2 negative • EGFR wild-type • CD276 expression
    |
    Tevimbra (tislelizumab-jsgr)
    5d
    A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Profiles, and Preliminary Efficacy of SYS6023 in Patients with Advanced Solid Tumors (ChiCTR2400089836)
    P1, N=388, Recruiting, Shanghai Chest Hospital; CSPC Megalith Biopharmaceutical Co., Ltd
    New P1 trial • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • PGR (Progesterone receptor) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • NRG1 (Neuregulin 1) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • EGFR mutation • KRAS G12C • BRAF mutation • HER-2 amplification • HER-2 negative • BRAF V600 • HER-2 expression • ALK positive • MET amplification • ALK fusion • ERBB3 expression • RET mutation • ROS1 fusion • MET mutation • NRG1 fusion • RET rearrangement • KRAS G12 • KRAS amplification • ER expression • PGR expression • ALK-ROS1 fusion • NRG1 fusion • NTRK fusion
    5d
    An exploratory clinical study to evaluate the safety, tolerability, and efficacy of low-dose radiotherapy (LDRT) and stereotactic radiotherapy (SBRT) combined with CAPEOX and tirellizumab in first-line treatment of HER2-negative advanced gastric cancer (ChiCTR2400089068)
    P1, N=36, Not yet recruiting, West China Hospital of Sichuan University; West China Hospital of Sichuan University
    New P1 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden)
    |
    PD-L1 expression • HER-2 negative
    7d
    Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant With Neoadjuvant Therapy (clinicaltrials.gov)
    P1, N=20, Recruiting, Yale University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Farxiga (dapagliflozin)
    7d
    Paxalisib Plus Olaparib or Pembrolizumab/Chemotherapy in Advanced Breast Cancer (ACTRN12624001340527)
    P1, N=24, Not yet recruiting, Kazia Therapeutics
    New P1 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • Lynparza (olaparib) • carboplatin • albumin-bound paclitaxel • paxalisib (GDC-0084)
    7d
    A clinical research study testing olaparib, in Homologous recombination (HR) deficient metastatic breast and relapsed ovarian cancer in patients who do not have hereditary mutations in BReast CAncer susceptibility gene 1 and gene 2 (BRCA1 and BRCA2) (ACTRN12617000855325)
    P2, N=60, Completed, University of Sydney | Terminated --> Completed
    Trial completion • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • BRCA (Breast cancer early onset) • MUC16 (Mucin 16, Cell Surface Associated)
    |
    HER-2 negative
    |
    Lynparza (olaparib)
    7d
    NeoTOP: Neoadjuvant Phase II Trial in Patients With T1c Operable, HER2-positive Breast Cancer According to TOP2A Status (clinicaltrials.gov)
    P2, N=86, Completed, UNICANCER | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 positive • HER-2 negative • HER-2 negative + HR negative • HER-2 positive + HR negative
    |
    Herceptin (trastuzumab) • carboplatin • docetaxel • Perjeta (pertuzumab) • cyclophosphamide • epirubicin
    7d
    IPATunity150: A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=20, Terminated, Hoffmann-La Roche | Phase classification: P3 --> P1
    Phase classification • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Ibrance (palbociclib) • fulvestrant • ipatasertib (RG7440)
    7d
    TRIFOUR: Nadunolimab in Combination with Gemcitabine Plus Carboplatin in Patients with Advanced Triple Negative Breast Cancer. (clinicaltrials.gov)
    P1/2, N=116, Recruiting, Cantargia AB | Trial primary completion date: Aug 2026 --> Jun 2025
    Trial primary completion date • Combination therapy • BRCA Companion diagnostic • PARP Companion diagnostic • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    BRCA2 mutation • BRCA1 mutation • HER-2 negative • HER-2 negative + HR negative • HER-2 negative + HR negative + BRCA mutation
    |
    PD-L1 IHC 22C3 pharmDx • Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    carboplatin • gemcitabine • nadunolimab (CAN04)
    7d
    ICARUS-BREAST01: Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=99, Active, not recruiting, Gustave Roussy, Cancer Campus, Grand Paris | Recruiting --> Active, not recruiting | N=170 --> 99 | Trial completion date: Jun 2026 --> Apr 2028 | Trial primary completion date: Jan 2024 --> Apr 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    patritumab deruxtecan (U3-1402)
    7d
    Differentiating HER2-low and HER2-zero tumors with 21-gene multigene assay in 2,295 h + HER2- breast cancer: a retrospective analysis. (PubMed, Breast Cancer Res)
    Within HR + HER2- breast cancer, HER2-low tumors are associated with high RS, especially for histologically invasive ductal carcinoma. A prognostic influence of HER2-low expression among HR + HER2- breast cancer remains as an area that requires further study.
    Retrospective data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative • HER-2 expression • HER-2 underexpression • HER-2 amplification + HR-positive
    |
    Oncotype DX Breast Recurrence Score®Test
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki)
    7d
    Magnetic resonance imaging-guided single-fraction preoperative radiotherapy for early-stage breast cancer (the RICE trial): feasibility study. (PubMed, Pilot Feasibility Stud)
    The RICE trial represents a significant step in breast cancer treatment, offering insights that could lead to treatment protocols with minimized RT appointments and enhanced patient outcomes.
    Journal • MRI
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
    8d
    CHENDO: CDK4/6-inhibitor or Chemotherapy, in Combination with ENDOcrine Therapy, for Advanced Breast Cancer / KENDO (clinicaltrials.gov)
    P2, N=52, Completed, Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori | Unknown status --> Completed | N=150 --> 52
    Trial completion • Enrollment change • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HR positive • HER-2 negative • HER-2 negative + ER positive
    |
    capecitabine • fulvestrant
    8d
    PALVEN: Palbociclib, Letrozole & Venetoclax in ER and BCL-2 Positive Breast Cancer (clinicaltrials.gov)
    P1, N=17, Active, not recruiting, Peter MacCallum Cancer Centre, Australia | Trial primary completion date: Jun 2024 --> Jun 2025
    Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • BCL2 (B-cell CLL/lymphoma 2)
    |
    ER positive • HER-2 negative • BCL2 positive • HER-2 negative + ER positive
    |
    Venclexta (venetoclax) • Ibrance (palbociclib) • letrozole
    8d
    Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation for Improved Breast Appearance in Patients With Low Risk, Hormone Responsive Breast Cancer (clinicaltrials.gov)
    P2, N=48, Suspended, City of Hope Medical Center | Recruiting --> Suspended
    Trial suspension
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    8d
    TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer (clinicaltrials.gov)
    P2, N=90, Active, not recruiting, Dana-Farber Cancer Institute | Recruiting --> Active, not recruiting | Trial primary completion date: Jan 2026 --> Jun 2025
    Enrollment closed • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    tamoxifen • Verzenio (abemaciclib) • letrozole • anastrozole • exemestane
    8d
    The Role of the NOLUS Score in Predicting pCR and iDFS in HR-positive HER2-negative Early Breast Cancer Patients who Received Neoadjuvant Chemotherapy. (PubMed, Cancer Diagn Progn)
    NOLUS positivity was observed in 20.43% of patients aged 22-50, compared to 8.93% in those over 50, though this difference was not statistically significant. NOLUS exhibits potential in predicting pCR in HR+/HER2- breast cancer, serving as a cost-effective substitute for genomic tests.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
    9d
    REALNESS: Observational Study on the Treatment of Patients With Metastatic Breast Cancer (clinicaltrials.gov)
    P=N/A, N=200, Not yet recruiting, AstraZeneca
    New trial • Real-world evidence • Real-world • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
    9d
    GO39733: A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors (clinicaltrials.gov)
    P1, N=272, Active, not recruiting, Genentech, Inc. | Trial completion date: Nov 2024 --> Mar 2025 | Trial primary completion date: Nov 2024 --> Mar 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • PGR negative
    |
    Tecentriq (atezolizumab) • autogene cevumeran (RG6180)
    10d
    E7389-J081-114: Study of E7389 Liposomal Formulation in Participants With Solid Tumor (clinicaltrials.gov)
    P1, N=140, Active, not recruiting, Eisai Co., Ltd. | Trial completion date: Aug 2025 --> Mar 2026
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 negative • PD-L1 negative
    |
    eribulin liposomal (E7389-LF)
    10d
    Talazoparib in Combination With Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer (clinicaltrials.gov)
    P1, N=26, Active, not recruiting, University of Michigan Rogel Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    Talzenna (talazoparib) • Beleodaq (belinostat)
    10d
    The LYSA (Linking You to Support and Advice) Trial (clinicaltrials.gov)
    P=N/A, N=200, Active, not recruiting, University College Cork | Trial completion date: Jun 2024 --> Dec 2024
    Trial completion date • HEOR
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HR positive • HER-2 negative
    10d
    Cost-Effectiveness of Multigene Prognostic Test to Guide Adjuvant Chemotherapy in HR+/HER2- Early Breast Cancer Patients in South Korea (ISPOR-EU 2024)
    A cost-effectiveness evaluation comparing the widely used ODX with BCT revealed that BCT is the dominant option in South Korea.
    Clinical • HEOR • Prognostic test • Cost-effectiveness • Cost effectiveness
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    GenesWell BCT • Oncotype DX Breast Recurrence Score®Test