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    TEST:
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay

    Company:
    NanoString Technologies, Veracyte
    Type:
    FDA Approved
    Related tests:
    9d
    Cisplatin With or Without Veliparib in Treating Patients With Recurrent or Metastatic Triple-Negative and/or BRCA Mutation-Associated Breast Cancer With or Without Brain Metastases (clinicaltrials.gov)
    P2, N=333, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Oct 2024 --> Mar 2025 | Trial primary completion date: Oct 2024 --> Mar 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • 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 • BRCA mutation
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    cisplatin • veliparib (ABT-888)
    12d
    Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=24, Active, not recruiting, National Cancer Institute (NCI) | Phase classification: P1/2 --> P1 | Trial completion date: Mar 2025 --> Jul 2025
    Phase classification • Trial completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor) • PTEN (Phosphatase and tensin homolog)
    |
    HER-2 amplification • HER-2 negative • PGR positive • HER-2 negative + PGR positive
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    Verzenio (abemaciclib) • fulvestrant • Aliqopa (copanlisib)
    12d
    Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study (clinicaltrials.gov)
    P3, N=27, Active, not recruiting, ECOG-ACRIN Cancer Research Group | Trial primary completion date: May 2028 --> Jun 2025
    Trial primary completion date • Surgery
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    Eligard (leuprolide acetate) • Nubeqa (darolutamide) • triptorelin • goserelin acetate • Viadur (leuprorelin implant)
    12d
    West African Genetic Ancestry and Breast Cancer Outcomes Among Black Women. (PubMed, JAMA Netw Open)
    Interestingly, full-time employment was associated with improved breast cancer DFS. These findings highlight the importance of considering genetic ancestry beyond self-reported race and accounting for social determinants of health, in efforts to improve survival outcomes among Black women with breast cancer.
    Journal • Observational data
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 negative • EGFR positive
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    16d
    Image analysis-based identification of high risk ER-positive, HER2-negative breast cancers. (PubMed, Breast Cancer Res)
    Given low rates of genomic testing uptake nationally, image-based methods may help identify ER+/HER2-patients who could benefit from testing.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    18d
    Decrescendo: De-escalation Adjuvant Chemo in HER2+/ER-/node-neg Early BC Patients Who Achieved PCR After Neoadjuvant Chemo & Dual HER2 Blockade (clinicaltrials.gov)
    P2, N=139, Terminated, Jules Bordet Institute | N=1065 --> 139 | Trial completion date: Mar 2029 --> Nov 2024 | Suspended --> Terminated | Trial primary completion date: Jun 2027 --> Nov 2024; Serious concerns on the slow recruitment of the study that impacts the robustness of the scientific rationale and the study financial provision. It aims to assess carefully the situation and to evaluate the potential solutions to overcome the issues.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • ER negative • PGR negative
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    Kadcyla (ado-trastuzumab emtansine) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
    23d
    Identifying predictors of treatment response and molecular changes induced by neoadjuvant chemotherapy and endocrine therapy in hormone receptor-positive/HER2-negative breast cancer: the NEOENDO translational study. (PubMed, ESMO Open)
    NACT was more effective in the molecular and dimensional tumor 'downstaging' than NET but baseline molecular features associated with differential responses according to treatment strategy. Examining baseline and post-treatment GE might help tailor more personalized and effective care.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • MMP11 (Matrix Metallopeptidase 11)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    26d
    Immune landscape of the tumour microenvironment in Ethiopian breast cancer patients. (PubMed, Breast Cancer Res)
    Immune gene expression profiling identified four distinct immune contextures of the TME with unique gene expression patterns and immune infiltration. The classification into distinct immune subgroups may provide important information regarding prognosis and the selection of patients undergoing conventional treatments or immunotherapies.
    Journal • IO biomarker
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    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PIK3CA mutation
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    1m
    MicroRNAome profiling of breast cancer unveils hsa-miR-5683 as a tumor suppressor microRNA predicting favorable clinical outcome. (PubMed, Cancer Cell Int)
    Our data provides comprehensive miRNA expression atlas in breast cancer subtypes and underscores the prognostic and therapeutic significance of numerous miRNAs, including hsa-miR-5683 in TNBC. The identified gene targets unravel the intricate regulatory network in TNBC progression, suggesting promising avenues for further research and targeted therapeutic interventions.
    Clinical data • Journal
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    HER-2 (Human epidermal growth factor receptor 2) • RACGAP1 (Rac GTPase activating protein 1)
    |
    HR positive
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    1m
    Geographic variation of Decipher risk score and underlying transcriptomic in patients with post prostatectomy early prostate cancer (EMUC 2024)
    Similarly, PSC basal-luminal shows the basal neuroendocrine-like is much higher in Israeli cohort 27% vs 7.5% (p=0.004). Conclusions These preliminary results suggest that geographic variation of decipher genomic classifier risk score in patients with early prostate cancer may exist, and correlate with differences in transcriptomic profile, including androgen receptor activity, p53 mutation, pTEN tumor suppressor gene deletion, and basal-luminal biologic phenotype.
    Clinical
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    TP53 (Tumor protein P53) • PTEN (Phosphatase and tensin homolog)
    |
    TP53 mutation • PTEN mutation • AR mutation
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • Decipher Prostate Cancer Test
    1m
    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
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    PD-L1 IHC 22C3 pharmDx • Prosigna™ Breast Cancer Prognostic Gene Signature Assay
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    carboplatin • gemcitabine • nadunolimab (CAN04)
    2ms
    Effects on Health and Costs of Delayed Implementation of the Oncotype DX® Test for Eligible Breast Cancer Patients (ISPOR-EU 2024)
    Implementing the Oncotype DX test for women with ER-positive and HER2-negative early breast cancer is of great value. Delayed implementation leads to increased costs, reduced quality of life, and life-years lost.
    Clinical
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    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
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    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • Oncotype DX Breast Recurrence Score®Test
    2ms
    Correlation of cell cycle arrest and intrinsic subtype with pathologic nodal status after neoadjuvant endocrine therapy – results from the Palbociclib and Endocrine therapy for Lobular breast cancer Preoperative Study (SABCS 2024)
    "The first 120 postmenopausal participants (60 with invasive ductal carcinoma [IDC] and 60 with invasive lobular carcinoma [ILC]) were randomized to letrozole versus tamoxifen for a 2-week window phase; all patients were then randomized 2:1 to a 24-week treatment phase of NET +/- Palbociclib (Palbo). Among patients treated with NET +/- Palbo, 43.6% of whom had ILC, 57.8% exhibited CCA. Most patients with available PAM50 results had luminal B subtype (61.3%). Cell cycle arrest after NET and baseline intrinsic subtype did not correlate with ypN status among patients treated with NET +/- Palbo."
    Clinical
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    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    Ibrance (palbociclib) • tamoxifen • letrozole
    2ms
    Enhancing Risk Stratification in HR+ Early Breast Cancer: A Real-World Evaluation of Oncotype Dx and Prosigna (SABCS 2024)
    Our study confirms that ODX and Prosigna provide different types of clinical information for postmenopausal HR+ EBC patients, as they analyze distinct genes and pathways. In our real-world cohort, Prosigna generally assigned a higher risk category compared to ODX. Therefore, integrating multiple molecular assays could potentially refine risk assessment and enhance personalized treatment strategies in this patient population.
    Clinical • HEOR • Real-world evidence • Real-world
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • Oncotype DX Breast Recurrence Score®Test
    2ms
    Deciphering the transcriptomic landscape of early HR+/HER2- breast cancer in very young women (SABCS 2024)
    These data suggest that HR+/HER2- tumors from VYBC patients could be more endocrine-resistant and immunoreactive than those from OBC patients. Accordingly, personalized therapeutic strategies in this subgroup are needed.
    Clinical • PD(L)-1 Biomarker • IO biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • PD-1 (Programmed cell death 1)
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    HER-2 negative
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    2ms
    Trial in progress: Imatinib to convert triple negative breast cancer into estrogen receptor (ER) positive breast cancer - a window of opportunity trial (SABCS 2024)
    Thirty-five patients will be recruited with an interim analysis planned after recruitment of 20 patients. The study is open for inclusion and 4 patients have been included as of 10th of June 2024.
    ER (Estrogen receptor)
    |
    ER positive • ER expression
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    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
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    imatinib
    2ms
    Decoupling of oestrogen response and proliferation in post-menopausal ER+ HER2- primary breast cancer after 2-week aromatase inhibitor treatment in the POETIC trial. (SABCS 2024)
    Spatial analysis reveals frequent gene expression and copy number heterogeneity in ER+ HER2- BC. Work aiming to quantify gene expression differences between subclones is ongoing.
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TFF1 (Trefoil Factor 1)
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    HER-2 negative • ER expression • ER-L
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    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    2ms
    Assessing the APIS Breast Cancer Subtyping Kit for RNA-Based Risk Stratification in Older Patients: Swiss Cohort Findings (SABCS 2024)
    The APIS Breast Cancer Subtyping Kit shows improved subtype call agreement with PAM50 in patients ≥65, indicating that molecular testing may be a more suitable method for determining proliferation and distinguishing between luminal A and B subtypes. Significant correlation between the APIS kit's PS, PAM50 and ODx indicates that APIS kit has the potential to accurately identify patients at risk of recurrence, although additional studies are needed to validate these results.
    Clinical
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    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HR positive
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    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • APIS Breast Cancer Subtyping Kit • Oncotype DX Breast Recurrence Score®Test
    2ms
    Molecular characterization of the NeoPalAna Endocrine Resistant (ET-R) Cohort: implications for CDK4/6 inhibitor (CDK4/6i) and ET resistance mechanisms in primary estrogen receptor positive (ER+) and HER2 negative (HER2-) breast cancer (BC). (SABCS 2024)
    Here we report the primary endpoint of complete cell cycle arrest (CCCA) and correlative studies of the NeoPalAna (NCT01723774) ET-R Cohort to examine resistance biomarkers for palbociclib (PAL) + anastrozole (ANA). Specific oncogenic pathways and immune tolerance markers, such as IDO1, were enriched in PAL-R. Our data also suggest immune modulatory effects of CDK4/6i/ET in association with ET/PAL response.
    BRCA Biomarker • IO biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA2 (Breast cancer 2, early onset) • NF1 (Neurofibromin 1) • CD8 (cluster of differentiation 8) • RUNX1 (RUNX Family Transcription Factor 1) • CCNE1 (Cyclin E1) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • CDK4 (Cyclin-dependent kinase 4) • CDH1 (Cadherin 1) • IDO1 (Indoleamine 2,3-dioxygenase 1) • NCOR1 (Nuclear Receptor Corepressor 1) • IRF4 (Interferon regulatory factor 4) • IFNA1 (Interferon Alpha 1)
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    TP53 mutation • ER positive • HER-2 negative • PIK3CA mutation • HER-2 negative + ER positive
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    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
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    Ibrance (palbociclib) • anastrozole
    2ms
    Intrinsic subtype expression between durable and poor responder during anti-HER2 treatment in triple-positive breast cancer (SABCS 2024)
    In this study, we analyzed the intrinsic subtype of HR positive, HER2 positive breast cancer based on prediction analysis of microarray 50 (PAM50) and Breast Cancer 360 panel (nanostring) between durable and poor responder in first-line docetaxel + trastuzumab + pertuzumab (THP) treated patients. Conclusions Other than HER2 pathway, ER pathway and inflammatory signal may influence the tumor response of HR(+), HER2 (+) breast cancer. Further clinical trials should be designed based not only on HER2 status, ER status and other molecular subtypes should be considered to maximize the clinical benefit.
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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    HER-2 positive • HR positive • HER-2 overexpression • HER-2 amplification + HR-positive • HER-2 overexpression + HR negative • HER-2 overexpression + HR positive • HER-2 positive + HER-2 overexpression • HER-2 positive + HR negative
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    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • nCounter® Breast Cancer 360™ Panel
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    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab)
    2ms
    Subtype by PAM50 changes after Neoadjuvant Endocrine therapy, from A Phase III Randomized, Double-Blind, Neoadjuvant Study of Hormonal Therapy plus Palbociclib versus Hormonal Therapy plus Placebo in ER+HER2- Operable Breast Cancer (SABCS 2024)
    Hormonal therapy consisted of letrozole for post-menopausal patients and tamoxifen plus LH-RH agonist for pre/peri-menopausal patients. Neoadjuvant endocrine therapy for 16 weeks changes subtype classification by PAM50 from luminal B to luminal A and the ROR drastically. Greater effects were noted for the combination, not statistically significant, but this warrants further investigation in a larger cohort. There were 3 HER2-enriched cases with poor response, but this was not significant because of the small sample size.
    Clinical • P3 data
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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    HR positive • HER-2 negative
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    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • EndoPredict® • Oncotype DX Breast Recurrence Score®Test
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    Ibrance (palbociclib) • tamoxifen • letrozole
    2ms
    The UNDERSTAND trial: a multi-omic platform for investigating CDK4/6 inhibitors resistance mechanisms in HR+ advanced breast cancer. (SABCS 2024)
    Conclusions Our highly integrated infrastructure allows us to collect and integrate unprecedented longitudinal multiomic molecular data from HR+/HER2- mBC patients. A combination of genomic, transcriptomic, and epigenetic analyses will provide a more accurate characterization of primary and acquired resistance mechanisms to CDK4/6i.
    Metastases
    |
    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) • NRAS (Neuroblastoma RAS viral oncogene homolog) • FGFR2 (Fibroblast growth factor receptor 2) • FGFR1 (Fibroblast growth factor receptor 1) • HRAS (Harvey rat sarcoma viral oncogene homolog) • RB1 (RB Transcriptional Corepressor 1) • AKT1 (V-akt murine thymoma viral oncogene homolog 1) • AURKA (Aurora kinase A) • CCNE2 (Cyclin E2)
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    HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • TruSight Oncology 500 Assay
    2ms
    Luminal subtype independent immune-enrichment in inflammatory breast cancer based on commercially available tumor portrait. (SABCS 2024)
    Over half of cases with luminal molecular phenotype demonstrate immune-enriched TME, suggesting a potentially significant role for immunotherapy in these patients and expanded efforts in this arena. Using the BG Tumor PortraitTM assay, low TMB and MSS was present in the majority of IBC samples evaluated in spite of numerous studies showing common DNA repair mutations. HER2 expressing cases demonstrated a predominantly immune-desert phenotype and further study of the clinical relevance and validation of this is warranted.
    Tumor mutational burden • IO biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • PTEN (Phosphatase and tensin homolog) • RB1 (RB Transcriptional Corepressor 1) • ARID1A (AT-rich interaction domain 1A) • RAD51B (RAD51 Paralog B) • FANCL (FA Complementation Group L)
    |
    TP53 mutation • TMB-H • HR positive • HER-2 negative • PIK3CA mutation • HER-2 mutation • HER-2 expression • PTEN mutation • ARID1A mutation • TMB-L • RAD51B mutation
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    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • BostonGene Tumor Portrait™ Test
    2ms
    Intrinsic Subtype at Progression to CDK4/6 Inhibitors Plus Endocrine Therapy in Hormone Receptor-Positive/HER2-Negative Metastatic Breast Cancer (MBC). (SABCS 2024)
    Overall, CDKi+ET had been administered in 1st, 2nd and ≥3rd line in 65.1%, 14.8% and 20.1% cases, with 54.0% patients progressing to ribociclib as CDKi and 57.1% progressing to letrozole as ET. Subtype switching towards less ET-sensitive IS, especially the HER2E, occurs under CDKi+ET and has prognostic value. Post-CDKi LumA disease showed the best outcomes, regardless of treatment type. This group of patients might be the ideal group to be treated with ET-based therapies.
    Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • FGFR4 (Fibroblast growth factor receptor 4)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    Kisqali (ribociclib) • letrozole
    2ms
    Integrative Bioinformatics Approach Reveals Potential Liquid Biopsy-based Biomarkers for Breast Cancer Metastasis Monitoring (SABCS 2024)
    Through an integrative computational analysis, we identified 12 markers associated with breast cancer metastasis, of which 8 were specifically linked to metastasis in TNBC. These markers are involved in diverse functions and pathways that contribute to the metastatic process in breast cancer. Future studies will focus on validating these biomarkers using liquid biopsy samples from breast cancer patients, potentially offering a less invasive diagnostic approach.
    Liquid biopsy • Biopsy
    |
    EPHB4 (EPH receptor B4) • CD93 (CD93 Molecule) • GAPDH (Glyceraldehyde-3-Phosphate Dehydrogenase) • HPRT1 (Hypoxanthine Phosphoribosyltransferase 1) • MMP1 (Matrix metallopeptidase 1) • MMP11 (Matrix Metallopeptidase 11) • HSPD1 (Heat Shock Protein Family D (Hsp60) Member 1)
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    2ms
    NeoTAILOR: A phase II biomarker-directed approach to guide neoadjuvant therapy for patients with clinical stage II/III ER+, HER2- negative breast cancer (SABCS 2024)
    Eligible pts (n=81) will undergo baseline (BL) breast MRI and tumor/blood collection, followed by a 28-day cycle of anastrozole (ana) (+/- 14 days, C1), during which BC risk category will be determined based on BL tumor Ki67 and study-funded Prosigna(R) PAM50 subtype...If responses are observed in ≥16 pts among 23 ORR evaluable pts, the trial claims preliminary efficacy. The study is actively enrolling pts at Siteman Cancer Center.
    Clinical • P2 data
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • HER-2 negative + ER positive
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    anastrozole
    2ms
    De-escalation of chemotherapy in patients with HER2-positive, hormone receptor negative, node-negative early breast cancer: primary results of the phase II DECRESCENDO trial (SABCS 2024)
    Patients received neoadjuvant treatment with taxanes and subcutaneous fixed dose combination pertuzumab and trastuzumab (P+T) for a total duration of 12 weeks followed by surgery. Adjuvant treatment was determined according to response at surgery: patients with a pathologic complete response (pCR, defined as pT0/Tis pN0) received adjuvant P+T for additional 14 cycles, while patients with residual disease received adjuvant trastuzumab emtansine (T-DM1) for 14 cycles... Neoadjuvant treatment with an anthracycline-free regimen in patients with HER2-positive, hormone receptor negative, node-negative early breast cancer resulted in a high rate of pCR. The majority of patients achieving pCR had the HER2-enriched PAM50 subtype.
    Clinical • P2 data
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 positive + HR negative
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    Kadcyla (ado-trastuzumab emtansine) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
    2ms
    Genomic and transcriptomic analyses of residual invasive triple-neg breast cancer after neoadjuvant chemotherapy in prospective MIRINAE trial (a randomized phase II trial of adjuvant atezolizumab + capecitabine versus capecitabine; KCSG-BR18-21). (SABCS 2024)
    TIL-high tumors were associated with immune-enriched cancer including BLIA and TME subtypes. Ongoing analysis of invasive disease-free survival as the primary endpoint in each arm of MIRINAE trial and the role of atezolizumab in association with genomic features will provide deeper insights into the role of ICIs as adjuvant therapy.
    Clinical • P2 data • BRCA Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PTEN (Phosphatase and tensin homolog) • AR (Androgen receptor) • HRD (Homologous Recombination Deficiency) • CD8 (cluster of differentiation 8) • PALB2 (Partner and localizer of BRCA2) • IFNG (Interferon, gamma) • LAG3 (Lymphocyte Activating 3) • PIK3R1 (Phosphoinositide-3-Kinase Regulatory Subunit 1) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • CD4 (CD4 Molecule) • CXCL13 (Chemokine (C-X-C motif) ligand 13) • IRF4 (Interferon regulatory factor 4) • CD3D (CD3d Molecule) • GZMK (Granzyme K) • NDRG1 (N-Myc Downstream Regulated 1)
    |
    TP53 mutation • BRCA1 mutation • PIK3CA mutation • PALB2 mutation • PIK3R1 mutation
    |
    FoundationOne® CDx • Prosigna™ Breast Cancer Prognostic Gene Signature Assay
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    Tecentriq (atezolizumab) • capecitabine
    2ms
    Spatial transcriptomics identifies molecular patterns predictive of response to neoadjuvant chemotherapy in triple-negative breast cancer. (SABCS 2024)
    To date, we have performed ST profiling of 120 TNBCs from 85 patients (40 Non-Responders; 45 Responders), totalling 4506 tumour or immune-cell enriched regions. Genes signatures known to predict pCR of NACT in women with TNBC were first assessed by generating a pseudo-bulk dataset produced in silico by combining gene counts from all regions. Two gene signatures, namely the PAM50 proliferation signature and the GeparSixto Immune signature, were found to be predictive (PAM50: OR = 0.12, p-value = 0.06; GeparSixto: OR= 0.19, p-value = 0.03) in our data.
    Clinical
    |
    PTPRC (Protein Tyrosine Phosphatase Receptor Type C)
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    2ms
    Low Ki67 is associated with a lower pathological complete response rate after neoadjuvant therapy in HER2-positive breast cancer patients. (SABCS 2024)
    Tumors with Ki67 <30 were associated with a lower rate of pCR after completing neoadjuvant treatment. Ki67 was kept as an independent predictor for pCR regardless of the use of neoadjuvant antracycline or trastuzumab plus pertuzumab, and HER2 score as evaluated by IHC. In the future, PAM 50 or another multigenic test may better fit these patients into different prognostic subgroups and help to de-escalate treatment.
    Clinical
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab)
    2ms
    Assessment of the immune microenvironment of the breast cancer PAM50 Subtypes – a deconvolution approach (SABCS 2024)
    Our findings show that the PAM50 subtypes may have overall differences in their immune microenvironment landscape which could be taken in consideration when explaining response to therapy or prognosis.
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER negative
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    2ms
    Characterization of patritumab deruxtecan activity in breast cancer (BC) patient-derived xenograft (PDX) models (SABCS 2024)
    The antitumor activity of HER3-DXd (10 mg/kg or 3 mg/kg dosed once weekly, 4 doses in total; Q1W x 4) was assessed in 30 BC PDX models (21 ER+/HER2- and 9 triple negative [TNBC]) and compared to the antitumor activity of the clinically approved TOP1 inhibitor irinotecan (50 mg/kg dosed once weekly; Q1W). HER3-DXd exerts a potent antitumor response in BC PDXs across baseline levels of HER3/ERBB3 expression in ER+/HER2- and TNBC models. Based on our data, basal-like PDX models were more likely to show long-term responses to HER3-DXd than luminal B PDX models. Results also suggest that BRCA1/2-altered PARPi-resistant tumors will show high benefit with HER3-DXd treatment.
    Clinical • BRCA Biomarker • PARP Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PTEN (Phosphatase and tensin homolog) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • RB1 (RB Transcriptional Corepressor 1) • RPA2 (Replication Protein A2)
    |
    HER-2 negative • HER-2 expression • ERBB3 expression • ERBB3 overexpression
    |
    MSK-IMPACT • Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    irinotecan • patritumab deruxtecan (U3-1402)
    2ms
    Role of MCM2 and the licensing complex in predicting endocrine and CDK4/6 inhibitor resistance in ER+ breast cancer (SABCS 2024)
    Our analysis demonstrates that MCM2 and the LC gene set are independently poorly-prognostic for both DRFS and BCSS in a large, well-annotated BC dataset. This impact is significant and does not wane after multivariate analysis. Most LC components, including MCM2, are not routinely included in targeted next-generation sequencing panels, and their incorporation can help validate the predictive nature of these genes in real-world cohorts.
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CDT1 (Chromatin Licensing And DNA Replication Factor 1) • MCM2 (Minichromosome maintenance complex component 2) • ORC1 (Origin Recognition Complex Subunit 1)
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    HER-2 negative
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    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    2ms
    Molecular effects of short pre-operative endocrine therapy in hormone receptor-positive and HER2-negative early breast cancer (SABCS 2024)
    This is a retrospective study of paired samples from patients (pts) with hormone receptor-positive and HER2-negative (HR+/HER2-) EBC treated at Hospital Clinic of Barcelona between 2014 and 2023 and from the letrozole arm of SOLTI-1501 VENTANA trial (Adamo et al...All pts received POET for 2 to 12 weeks prior to surgery, with tamoxifen or aromatase inhibitors (AI), administered according to menopausal status... POET is a simple and secure treatment that can be administrated before surgery in HR+/HER2- EBC. The molecular profiling and dynamic evaluation of biological changes induced by POET could offer opportunities for a better understanding of the tumor´s sensitivity to endocrine therapy and could help guide and optimize treatment strategies in HR+/HER2- EBC.
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • FOXA1 (Forkhead Box A1) • MYBL2 (MYB Proto-Oncogene Like 2)
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    HR positive • HER-2 negative • HR positive + HER-2 negative
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    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • HER2DX
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    tamoxifen • letrozole
    2ms
    Pathological Complete Response and Survival Outcomes of Single Hormone Receptor-Positive/HER2-Negative Breast Cancer after Neoadjuvant Treatment and Further analysis of its Intrinsic Biological Features and Immune Landscape (SABCS 2024)
    Patients with sHR+/HER2- breast cancer were characterized by relative sensitivity to neoadjuvant chemotherapy but worse prognosis, resembling triple-negative breast cancer in biological behavior. Immune relatively hot phenotypes of sHR+/HER2- breast cancer revealed a potential to benefit from immunotherapy.
    Clinical • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • PGR (Progesterone receptor) • TMB (Tumor Mutational Burden) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1)
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    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
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    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    2ms
    Visceral adiposity is associated with survival and distinct gene expression patterns in HER2-enriched subtype tumors (SABCS 2024)
    Excess visceral adiposity was associated with shorter survival and increased expression of stroma and mammary stemness genes in tumors of patients with HER2-enriched breast cancer, suggesting adiposity's contribution to breast cancer progression differs by molecular intrinsic subtype. This translational study provides additional evidence for the importance of excess adiposity as is a major modifiable risk factor for patient survival.
    HER-2 (Human epidermal growth factor receptor 2) • DDR2 (Discoidin domain receptor 2) • SALL4 (Spalt Like Transcription Factor 4) • COL6A3 (Collagen Type VI Alpha 3 Chain) • ADAM12 (ADAM Metallopeptidase Domain 12) • HEG1 (Heart Development Protein With EGF Like Domains 1)
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    HER-2 expression
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    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • nCounter® Breast Cancer 360™ Panel
    2ms
    Evaluating the Impact of Prosigna® Testing on Adjuvant Chemotherapy Decisions in Early-Stage ER-Positive, HER2-Negative Breast Cancer: A UK Study (SABCS 2024)
    Anthracycline and Taxane-based regimens were most common (76%), followed by Docetaxel and Cyclophosphamide (24%). This study presents the first real-world data on the implementation of Prosigna® in the UK, potentially optimizing future national guidelines. These findings highlight the importance of tumor grade and prognostic indices in risk stratification, offering valuable insights for personalized breast cancer management.
    Clinical
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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    ER positive • HER-2 negative • HER-2 negative + ER positive
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    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
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    docetaxel • cyclophosphamide
    2ms
    Molecular heterogeneity in adjacent normal tissue among Chinese breast cancer patients (SABCS 2024)
    Using methylation data in an expanded dataset, we extended our previous analysis of paired tumor and NAT samples to characterize breast cancer field effect. Our main findings illuminate the diverse nature of the microenvironment surrounding the tumor and its potential influence on the genomic evolutionary path of the tumor.
    Clinical • Tumor mutational burden
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    TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • CD14 (CD14 Molecule)
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    TP53 mutation
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    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    2ms
    Real-World Use of Gene Expression Tests in Swedish Breast Cancer Patients: A Multi-Institutional Study of 35 hospitals (SABCS 2024)
    The variability in risk score distribution among hospitals may also be due to the different GEPs being used. Further standardization of clinical practice guidelines is needed to decrease the large variability in the use of GEP in practice and to limit the associated risk for incorrect patient selection for breast cancer treatment.
    Clinical • Real-world evidence • Real-world
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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    HER-2 negative
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    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • Oncotype DX Breast Recurrence Score®Test
    2ms
    Secretory Carcinoma: Clinical, Pathological and Molecular Insights into a Rare Breast Cancer Subtype (SABCS 2024)
    A total of 15 SCB tumors from 9 patients were analyzed, with 4 patients providing paired primary and relapsed tumor samples. The median age at diagnosis was 64 years (range 45-78). Median tumor size was 1.7 cm (range 0.6-9.5 cm).
    Clinical
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • NTRK (Neurotrophic receptor tyrosine kinase)
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    HER-2 negative
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    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • VENTANA pan-TRK (EPR17341) Assay
    2ms
    Gene Expression patterns in early ER+/HER2- breast cancer treated with neoadjuvant chemotherapy versus CDK4/6 inhibitor therapy: results from the Swedish PREDIX Luminal B trial (SABCS 2024)
    Objective response of ER+/HER2- breast cancer to neoadjuvant palbociclib/endocrine therapy or paclitaxel is governed by different biologic processes. Further translational studies are ongoing to identify predictors of response and the best sequence of treatments.
    Clinical
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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    HER-2 negative
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    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
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    Ibrance (palbociclib) • paclitaxel
    2ms
    Predicting response to capivasertib in AKT1 mutant advanced breast cancer (SABCS 2024)
    Allelic imbalance at the AKT1 locus and clonal dominance of the AKT1 mutation were associated with progression free survival (PFS) in plasmaMATCH Cohorts C (capivasertib plus fulvestrant) and D (capivasertib alone) combined. Breast cancers with mutations in AKT1 frequently have allelic imbalance favouring the mutation, resulting in increased expression of mutant transcript. Allelic imbalance of AKT1, and/or clonally dominant AKT1 mutations, were prognostic for significantly greater PFS of patients treated with capivasertib.
    Metastases
    |
    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) • CDH1 (Cadherin 1) • MAP3K1 (Mitogen-Activated Protein Kinase Kinase Kinase 1) • GATA3 (GATA binding protein 3)
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    TP53 mutation • PIK3CA mutation • AKT1 mutation • AKT1 Q79K
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    Guardant360® CDx • Prosigna™ Breast Cancer Prognostic Gene Signature Assay
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    fulvestrant • Truqap (capivasertib)