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    GENE:

    ER (Estrogen receptor)

    i
    Other names: ESR1, Era, ESR, NR3A1, ER, ER beta
    1d
    Regulatory mechanisms of steroid hormone receptors on gene transcription through chromatin interaction and enhancer reprogramming. (PubMed, Cell Oncol (Dordr))
    In addition, we have presented four enhancer reprogramming mechanisms (transcription factor cooperation, pioneer factor binding, dynamic assisted loading, and tethering) and the multiple enhancer-promoter contact models. Based on these mechanisms and models, this review proposes that the combination of multiple therapy strategies such as agonists/antagonists of SHRs plus endocrine therapy and the adoption of the latest sequencing technologies are expected to improve the efficacy of ER positive breast cancer treatment.
    Review • Journal
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor) • AR (Androgen receptor)
    |
    ER positive
    1d
    Tissue-based Next Generation Sequencing (NGS) for Patients with Advanced Solid Tumors: the experience of Verona University Hospital (AIOM 2024)
    Our study provides an example of implementation of molecular profiling in an academic pre-screening program. Further analysis will investigate treatment matching rates, drug access schemes, and their impact on treatment efficacy and survival.
    Clinical • Next-generation sequencing • BRCA Biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • 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) • TMB (Tumor Mutational Burden) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • FGFR2 (Fibroblast growth factor receptor 2) • PTEN (Phosphatase and tensin homolog) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1)
    |
    BRAF V600E • KRAS mutation • BRCA2 mutation • BRCA1 mutation • EGFR mutation • KRAS G12C • HER-2 amplification • PIK3CA mutation • BRAF V600 • NTRK1 fusion • PTEN mutation • KIT mutation • FGFR2 mutation • RET mutation • MET mutation • KRAS G12 • ESR1 mutation • NTRK1 mutation • BRAF amplification
    |
    FoundationOne® CDx • TruSight Oncology 500 Assay
    1d
    Use of OncotypeDx in women with ER+/HER2- breast cancer after surgery: the experience of Ancona Breast Unit (AIOM 2024)
    According to literature, and TailorX trial data, our study confirms the importance of ODX as a tool able to guide therapeutic choices and ensure patients the most appropriate adjuvant treatment.
    Clinical • Surgery
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • PGR expression
    |
    Oncotype DX Breast Recurrence Score®Test
    1d
    Role of Immunotherapy in Conjunction With the Surgical Treatment of Breast Cancer: Preoperative and Postoperative Applications. (PubMed, Cureus)
    Fourteen different articles showed that the use of cytokines and cancer vaccines revealed new possibilities to treat breast cancer with antibodies against PD-1/PD-L1 (pembrolizumab), PI3K/Akt/mTOR (alpelisib and everolimus), CAR T-cell (chimeric antigen receptor), PARP (poly ADP-ribose polymerase), and CTLA4 (cytotoxic T-lymphocyte-associated protein 4), and with representative relevance of changing in tumor microenvironment. Estrogen receptor (ER) and human epidermal growth factor receptor 2 (HER2) targets show also a high effectivity. In recent years, the release of new strategies has become promising, for changing the microenvironment and de-escalation of therapy based on tumor biology, novel biomarkers, and tumor spread.
    Review • Journal • PARP Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • PARP1 (Poly(ADP-Ribose) Polymerase 1)
    |
    Keytruda (pembrolizumab) • everolimus • Piqray (alpelisib)
    1d
    Elacestrant plus alpelisib in an ESR1 and PIK3CA co-mutated and heavily pretreated metastatic breast cancer: the first case report for combination efficacy and safety. (PubMed, Ther Adv Med Oncol)
    We achieved a remarkable response in the metastatic lesions with minor toxicity issues. This case highlights the importance of utilizing up-to-date therapeutic agents and reactive decision-making during personalized cancer treatment.
    Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HR positive • HER-2 negative • PIK3CA mutation • ER mutation • ESR1 mutation • CDK4 mutation
    |
    Piqray (alpelisib) • Orserdu (elacestrant)
    1d
    Identification of Active Ingredients in Ginseng Volatile Oil: A Strategy Combining Computer Virtual Screening With Experimental Validation. (PubMed, Phytochem Anal)
    This research proposed a strategy that integrated "component detection-virtual multitarget screening-active component prediction-experimental verification" to expedite the identification of active ingredients, providing insights for application of FG and the development of functional products.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • ER (Estrogen receptor)
    1d
    Stromal tumor infiltrating lymphocytes in hormone receptor positive/HER2 negative metastatic breast cancer. (PubMed, Mod Pathol)
    Finally, sTIL levels were significantly higher in lung and axillary lymph node metastases compared to all metastases. While these analyses were conducted on multiple metastases obtained at the end of life after several lines of treatment, the data provides novel and valuable insights into the state of immune infiltration in patients with metastatic HR+/HER2- BC.
    Journal • Tumor-infiltrating lymphocyte • Stroma • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 positive • HR positive • HER-2 negative • ER negative • HR positive + HER-2 negative • PTEN mutation + HR positive • HER-2 negative + ER positive
    2d
    Recent advances in microfluidic chip technologies for applications as preclinical testing devices for the diagnosis and treatment of triple-negative breast cancers. (PubMed, Pathol Res Pract)
    This review focuses on the topic of tumor-on-a-chip, microfluidic chip manufacturing, and drug screening for triple-negative breast cancer. Particular emphasis is placed on cancer biomarker diagnostics, 3D preclinical model development, and treatment strategies for triple-negative breast cancer.
    Preclinical • Review • Journal
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 expression
    2d
    NSDHL contributes to breast cancer stem-like cell maintenance and tumor-initiating capacity through TGF-β/Smad signaling pathway in MCF-7 tumor spheroid. (PubMed, BMC Cancer)
    Our findings suggest that NSDHL regulates the BCSC/tumor-initiating cell population in MCF-7 spheroids and xenograft tumors.
    Journal
    |
    ER (Estrogen receptor) • EPCAM (Epithelial cell adhesion molecule) • SOX2 • CD24 (CD24 Molecule) • TGFB1 (Transforming Growth Factor Beta 1) • ITGA6 (Integrin, alpha 6)
    |
    ER positive • SOX2 expression
    2d
    Small phenolic compounds as potential endocrine disruptors interacting with estrogen receptor alpha. (PubMed, Front Endocrinol (Lausanne))
    The direct interaction of the most active compounds with the ERα ligand binding domain (LBD) was further tested in cell-free experiments using the recombinant form of the LBD, and 4-chloropyrocatechol was shown to behave like E2 with about 1/3 of the potency of E2. Our results provide evidence that some of these compounds can be considered potential endocrine disruptors interacting with ERα.
    Journal
    |
    ER (Estrogen receptor) • TFF1 (Trefoil Factor 1)
    2d
    Krukenberg tumours: which patients should be considered for surgery?-a narrative literature review. (PubMed, Transl Cancer Res)
    Diagnostic laparoscopy could be considered before debulking surgery, to assess resectability of disease and to avoid a futile exploratory laparotomy. HIPEC after cytoreductive surgery (CRS) remains controversial, with possible survival benefit for KTs of gastric origin, particularly when peritoneal dissemination is present but the PCI is low.
    Review • Journal • Surgery
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    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER expression
    2d
    Shengqiyichang decoction regulates antitumor immunity in colorectal cancer by downregulating lymphocyte antigen 6 family member G6D via the protein kinase B/p38 mitogen-activated protein kinase signaling pathway. (PubMed, Heliyon)
    In cultured mouse CRC cells, SQYCD selectively upregulated levels of the CRC-associated protein lymphocyte antigen 6 family member G6D, while the AKT activator SC-79 reversed this effect. The discoveries made herein suggest that SQYCD exerts a therapeutic effect in CRC by inhibiting Treg recruitment via inhibition of the AKT/p38α/LY6G6D signaling axis.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • ER (Estrogen receptor) • CD8 (cluster of differentiation 8) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule) • MAPK1 (Mitogen-activated protein kinase 1) • CASP3 (Caspase 3) • PRKACA (Protein Kinase CAMP-Activated Catalytic Subunit Alpha) • LY6G6D (Lymphocyte Antigen 6 Family Member G6D) • MAPK14 (Mitogen-Activated Protein Kinase 14)
    2d
    Surveillance of Disease Progression in Metastatic Breast Cancer by Molecular Counting of Circulating Tumor DNA Using Plasma-SeqSensei Breast Cancer in Vitro Diagnostics Assay. (PubMed, J Mol Diagn)
    PSS validates a previously developed ddPCR classifier: 100 copies/mL (2.5% VAF); and confirms progression, with negative predictive value (95% CI) of 83% (76%-88%) and positive predictive value (95% CI) of 91% (81%-96%) (weighted κ, 0.856; 95% CI, 0.797-0.915). PSS thus confirms robust clinical thresholds (10 to 100 copies/mL, 0.25% to 2.5% VAF) for metastatic breast cancer surveillance, using absolute molecular counting.
    Preclinical • Journal • Circulating tumor DNA • Metastases
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    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • AKT1 (V-akt murine thymoma viral oncogene homolog 1)
    |
    TP53 mutation • PIK3CA mutation
    2d
    Incorporating immunotherapy in the management of early-stage estrogen receptor-positive breast cancer. (PubMed, ESMO Open)
    No abstract available
    Journal
    |
    ER (Estrogen receptor)
    |
    ER positive
    3d
    Hormonal biomarkers remain prognostically relevant within the molecular subgroups in endometrial cancer. (PubMed, Gynecol Oncol)
    We demonstrated that ER/PR expression remain prognostically relevant within the molecular subgroups, and that a three-tiered cutoff refines prognostication. These data support incorporating routine evaluation of ER/PR expression in clinical practice.
    Journal
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    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    MSI-H/dMMR • TP53 expression • PGR expression
    3d
    Photochemical Metal-Free synthesis and biological Assessment of isocryptolepine analogues targeting estrogen receptor Alpha in breast cancer cells. (PubMed, Bioorg Chem)
    Compound 3c induced apoptosis, as evidenced by PARP cleavage and downregulation of p-Bcl-2 and Bcl-2, and demonstrated synergistic effects in combination with the chemotherapeutic agent 5-fluorouracil. Compound 3c also showed selectivity towards hormone-dependent breast cancer cells, likely targeting ERα - a key driver in this cancer subtype. In summary, we report the development of a first-in-class antiestrogenic isocryptolepine with notable pro-apoptotic efficacy.
    Journal
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    ER (Estrogen receptor) • BCL2 (B-cell CLL/lymphoma 2)
    |
    5-fluorouracil
    3d
    Real-world effectiveness of CDK 4/6 inhibitors in estrogen-positive metastatic breast cancer. (PubMed, BJC Rep)
    This study confirms first-line CDK 4/6i effectiveness, with abemaciclib and ribociclib showing prolonged PFS vs. palbociclib. This study could not confirm a ranking of the three CDK 4/6i.
    Journal • Real-world evidence • Real-world effectiveness • Real-world • Metastases
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 positive • ER positive • HER-2 negative • ER positive + HER-2 negative • HER-2 negative + ER positive
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib)
    3d
    Testing the Addition of an Anti-cancer Drug, Berzosertib, to the Usual Treatment (Radiation Therapy) for Chemotherapy-Resistant Triple-Negative and Estrogen and/or Progesterone Receptor Positive, HER2 Negative Breast Cancer (clinicaltrials.gov)
    P1, N=42, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    berzosertib (M6620)
    3d
    Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005) (clinicaltrials.gov)
    P2, N=603, Completed, Merck Sharp & Dohme LLC | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib)
    3d
    Immunohistochemical-Based Molecular Subtypes of Female Breast Cancer: A Retrospective Cross-Sectional Study at Cheikh Khalifa Hospital in Casablanca, Morocco. (PubMed, Cancer Control)
    Our findings should be used to guide breast cancer management policies in Morocco. Larger cohort studies are needed to determine the specificity of the breast cancer profile in Morocco as well as the epidemiological risk factors specific to every subtype.
    Observational data • Retrospective data • Journal
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • ER positive • HR positive • PGR positive
    3d
    PhAST: First-in-human Trial of PhOx430, a First-in-class Acetylglucosaminyltransferase V Inhibitor, in Advanced Solid Tumours (clinicaltrials.gov)
    P1, N=149, Recruiting, Phost'In Therapeutics | Trial primary completion date: Jul 2024 --> Nov 2024
    Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 overexpression • HER-2 negative
    |
    PhOx430
    3d
    Using bioinformatics and artificial intelligence to map the cyclin-dependent kinase 4/6 inhibitor biomarker landscape in breast cancer. (PubMed, Future Oncol)
    To identify biomarkers associated with CDK4/6 inhibitor response or resistance, we combined bioinformatic-database analyses, artificial intelligence-assisted literature review, and manual literature review (Embase and OVID Medline; search window: January 2012-October 2022) to compile data to comprehensively describe the CDK4/6 inhibitor biomarker landscape. Based on these results, and validation by external experts, we identified 15 biomarkers of clinical importance (AR , AURKA, ERBB2, ESR1, CCNE1, CDKN1A/B, CDK2, CDK6, CDK7, CDK9, FGFR1/2, MYC, PIK3CA/AKT, RB1 and STAT3) that could guide future breast cancer research.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • FGFR1 (Fibroblast growth factor receptor 1) • RB1 (RB Transcriptional Corepressor 1) • CCNE1 (Cyclin E1) • STAT3 (Signal Transducer And Activator Of Transcription 3) • AURKA (Aurora kinase A) • CDK2 (Cyclin-dependent kinase 2) • CDK7 (Cyclin Dependent Kinase 7) • CDK9 (Cyclin Dependent Kinase 9) • CDKN1A (Cyclin-dependent kinase inhibitor 1A)
    |
    HR positive • HER-2 negative • EGFR positive
    3d
    Impact of major depressive disorder on breast cancer outcomes: a national retrospective cohort study. (PubMed, J Natl Cancer Inst)
    Women with MDD had inferior BC outcomes compared to women without a history of MDD. Research is needed to investigate underlying mechanisms linking depression to BC progression and evaluate interventions to improve outcomes in this high-risk population.
    Retrospective data • Journal
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    ER (Estrogen receptor)
    |
    ER positive
    4d
    Novel Nordaucane Sesquiterpenoid and Sesquiterpene Lactone From Laserpitium Species: Isolation, Structure Elucidation, In Vitro, In Vivo, and In Silico Evaluation as Anticancer Agents. (PubMed, Phytochem Anal)
    Compounds 7 and 9, representing new nordaucane and sesquiterpene lactones, have not been previously reported. In vitro cytotoxicity revealed that compound 7 exhibits potent anti-cancer activity against MCF-7 cells, whereas compound 9 showed reduced cytotoxicity. In vivo testing in Caenorhabditis elegans supported these findings, suggesting safety and efficacy in organisms. In silico results emphasize the potential of these compounds, with compound 7 promising due to its stability and strong binding affinity.
    Preclinical • Journal
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    ER (Estrogen receptor) • KDR (Kinase insert domain receptor)
    4d
    Phytochemicals as Novel Therapeutics for Triple-Negative Breast Cancer: A Comprehensive Review of Current Knowledge. (PubMed, Phytother Res)
    Phytochemicals categorized as alkaloids, polyphenols, terpenoids, phytosterols, and organosulfur compounds have been demonstrated to reduce cancer cell proliferation and metastasis by activating various molecular pathways, thereby reducing the spread of triple-negative breast cancer. This review analyzes the molecular mechanisms by which various phytochemicals fight triple-negative breast cancer and offers a perspective on the difficulties and potential prospects for treating triple-negative breast cancer with various phytochemicals.
    Review • Journal
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    4d
    Network pharmacology and molecular docking to explore the potential molecular mechanism of chlorogenic acid treatment of oral squamous cell carcinoma. (PubMed, Medicine (Baltimore))
    Enrichment analysis of therapeutic targets highlighted the critical roles of the MAPK-ERK and MAPK-JNK signaling pathways in the effectiveness of chlorogenic acid against OSCC. This study predicted the potential targets of chlorogenic acid in OSCC treatment and hypothesized its molecular mechanism, offering a theoretical foundation for its use in OSCC therapy.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • STING (stimulator of interferon response cGAMP interactor 1) • MAPK1 (Mitogen-activated protein kinase 1) • MMP2 (Matrix metallopeptidase 2) • MMP9 (Matrix metallopeptidase 9) • CDC42 (Cell Division Cycle 42) • MAPK8 (Mitogen-activated protein kinase 8)
    |
    chlorogenic acid
    4d
    Financial Difficulty Over Time in Young Adults With Breast Cancer. (PubMed, JAMA Netw Open)
    In this cohort study of young adults with breast cancer, we identified a subset of patients who experienced a high degree of financial difficulty persisting into early survivorship. Targeted interventions to mitigate financial toxicity-modifiable factors that include support for the employability or return to work support for those experiencing arm symptoms after treatment-are needed.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • ER positive + PGR positive • PGR positive
    4d
    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
    4d
    Z-Endoxifen Hydrochloride in Treating Patients With Metastatic or Locally Recurrent Estrogen Receptor-Positive Breast Cancer (clinicaltrials.gov)
    P1, N=62, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Oct 2024 --> Oct 2025
    Trial completion date
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • AKT1 (V-akt murine thymoma viral oncogene homolog 1) • mTOR (Mechanistic target of rapamycin kinase) • IGF1R (Insulin-like growth factor 1 receptor) • NCOA3 (Nuclear Receptor Coactivator 3) • PI3K (Phosphoinositide 3-kinases)
    |
    ER positive • HER-2 expression • EGFR expression
    |
    Zonalta (Z-endoxifen hydrochloride)
    4d
    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
    4d
    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
    5d
    A Prospective, Randomized Multicenter, Open-label Comparison of Preoperative Combination of Trastuzumab and Pertuzumab With or Without Concurrent Taxane Chemotherapy Given for Twelve Weeks in Patients With Operable HER2+/HR- Breast Cancer Within the ADAPT Protocol (clinicaltrials.gov)
    P2, N=220, Active, not recruiting, West German Study Group | Recruiting --> Active, not recruiting | Trial completion date: Oct 2024 --> Jan 2025 | Trial primary completion date: Aug 2015 --> Jan 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    PGR negative
    |
    Herceptin (trastuzumab) • paclitaxel • Perjeta (pertuzumab)
    5d
    Implementing Semi-quantitative Methods for Breast Cancer Biomarker Assessment Using the APIS Breast Cancer Subtyping Kit (AMP 2024)
    By leveraging the dynamic range of RNA expression, this study established a ΔCt semi-quantitative scale for evaluating targets with the APIS Breast Cancer Subtyping Kit. This is particularly significant for the classification of HER-low, which has emerged to be critical in identifying patients who may benefit from novel anti-HER2 therapies.
    ER (Estrogen receptor) • PGR (Progesterone receptor) • KEAP1 (Kelch Like ECH Associated Protein 1)
    |
    HER-2 overexpression • HER-2 expression
    |
    APIS Breast Cancer Subtyping Kit
    5d
    Highly Sensitive ESR1 Mutation Detection with the APIS Kit: Performance and LoD Testing in Varied Wild-Type Backgrounds (AMP 2024)
    The APIS ESR1 Mutations Kit demonstrated high sensitivity and specificity as a qualitative qPCR assay for detecting ESR1 mutations in varying WT backgrounds. Its performance with the SensID ESR1 Reference Set 1% AF cfDNA validated the kit's LoD at ≤1% MAF with external samples. The APIS kit is a valuable tool for assessing ESR1 mutations in both clinical and research settings, offering a more accessible alternative to traditional next-generation sequencing (NGS) and dPCR assays.
    ER (Estrogen receptor) • KIT (KIT proto-oncogene, receptor tyrosine kinase)
    |
    TP53 mutation • ER positive • KIT mutation • ER mutation • ER Y537S • ER D538G • ESR1 mutation • ER Y537C
    |
    APIS ESR1 Mutations Kit
    5d
    Characterization of ESR1-CCDC170 and Other Intra-Chromosomal Gene Fusions in FFPE Samples with Oncomine Precision Assay on Ion Torrent GeneXus System (AMP 2024)
    This report offers a thorough characterization of expected prevalence and expression levels for CSFs and NDFs with an NGS study of a broad scope. We describe ESR1 fusions in a cohort of thousands of breast tumors and show lower median expression levels relative to NDFs such as ALK, ROS1, and RET fusions. Our findings suggest that some CSFs, like ESR1 fusions in breast cancer, may be the result of tandem duplication with upstream partners, and may be subclonal and acquired later in cancer progression.
    ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • FGFR3 (Fibroblast growth factor receptor 3) • CCDC170(Coiled-Coil Domain Containing 170) • RSPO3 (R-Spondin 3)
    |
    RET fusion • MET exon 14 mutation • ROS1 fusion • FGFR3 fusion • ER-CCDC170 fusion
    |
    Oncomine Precision Assay
    5d
    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
    5d
    Genomic Landscape of Fusions in Solid Tumors Detected by DNA and RNA Comprehensive Genomic Profiling at a Large Community Health System (AMP 2024)
    The routine use of RNA-based CGP analysis allows for the comprehensive detection of oncogenic fusions in patients with cancer. The diversity of tumor types in which actionable fusions were detected supports the broader utilization of CGP to potentially increase targeted therapy usage and improve outcomes across cancer subtypes.
    Tumor mutational burden
    |
    ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • RET (Ret Proto-Oncogene) • PTEN (Phosphatase and tensin homolog) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    TMB-H • NTRK1 fusion • NTRK3 fusion • NTRK2 fusion • RET fusion • PTEN mutation • ALK fusion
    |
    TruSight Oncology 500 Assay
    5d
    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
    5d
    Low Limit of Detection Increases Detection and Reporting of Actionable Genomic Alterations (AMP 2024)
    The ability to detect SNVs and indels below 5% VAF increases the diagnostic yield of actionable genomic alterations. This enables additional patients to consider FDA-approved on-label targeted therapies as a treatment option. Taken together, CGP assays that couple high sensitivity and low LOD can maximize identification of therapeutically relevant alterations across solid tumor types.
    BRCA Biomarker
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • NRAS (Neuroblastoma RAS viral oncogene homolog) • BRCA2 (Breast cancer 2, early onset) • PTEN (Phosphatase and tensin homolog) • FGFR3 (Fibroblast growth factor receptor 3) • AKT1 (V-akt murine thymoma viral oncogene homolog 1)
    |
    BRAF V600 • PTEN mutation
    |
    OncoExTra™ test
    5d
    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)
    5d
    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 • Metastases
    |
    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
    6d
    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)