TEST:

Prosigna™ Breast Cancer Prognostic Gene Signature Assay

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.

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.

P1/2, N=116, Recruiting, Cantargia AB | Trial primary completion date: Aug 2026 --> Jun 2025

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.

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Furthermore, its effectiveness persists even with reduced training sample sizes. OmicsFootPrint marks an enhancement in multi-omics research, offering a novel, efficient and interpretable approach that contributes to a deeper understanding of disease mechanisms.

An identical result was obtained using three novel distance matrices (CMIN, CMAX, CAVG). This result supports the applicability of novel distance matrices based on the conductance method, and suggests that further investigations based on this approach are justified.

This study shows initial proof of principle that genomic classification in blood is possible using contemporary tool for blood component isolation and nanostring. Additional technical and clinical validation are needed prior to widespread implementation, but these methods may make it possible to increase the utilization of genomic classifiers in clinical studies and in practice.

Transcriptomes distinguished ETS -fused tumors from SPOP mutants, and PTEN loss from PTEN/AKT1 mutations. Inferred relationships between specific genomic alterations and gene expression signatures of luminal/basal subtypes and of biological pathways/processes, including AR signaling, proliferation, and plasticity signatures, provide a basis to understand differences in treatment response and inform biomarker-guided treatment strategies.

In the next phase, we aim to combine transcriptomic information with radiographic features to develop image-based breast cancer risk prediction models. This can aid in individualized breast cancer risk assessment and potentially guide personalized screening, prevention recommendations, and treatment decisions.

P2; Sunitinib plus exemestane was associated with substantial yet reversible toxicities, providing safety, efficacy and biological impact insights of combining an antiangiogenic drug with hormone therapy in early-stage breast cancer.Trial registration: Registered with ClinicalTrials.gov, NCT00931450. 02/07/2009.

P1/2; Trial primary completion date: Aug 2024 --> Aug 2026

P2; Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Aug 2024 --> Aug 2025

Rat mammary cancer subtypes resemble those in humans and are related to environmental factors.

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P=N/A; Trial primary completion date: Oct 2021 --> Oct 2025

According to our results, the Prosigna assay was found to be a relevant tool for the clinical decision making process. Long-term follow-up of these patients will elucidate the potential benefits of using multigene molecular tests as biomarkers for treatment.

This study presents a comprehensive analysis of the close correlation between TNFSF12 and prognosis, immune response, as well as the effectiveness of chemotherapeutic agents in BRCA patients.

The OS was very low in the patient cohort that received no (neo)adjuvant treatment. Immunohistochemistry and GEP confirmed endocrine-sensitive tumours in more than half of the patients, with a large proportion of Luminal B, HER2-enriched and Basal-like tumours so that adjuvant chemotherapy should be recommended.

The combination of chitin and grafting strategy can promote the development of strong chitin-based sustainable elastomers. This approach can be further utilized to design novel high-performance biobased elastomers and adhesives derived from natural resources.

PAM50 and immune-related signatures provide important prognostic information in patients with T1abN0 breast cancer, which may refine the risk assessment in these patients.

Using long-term follow-up data, this study showed that the ROR score can predict the prognosis of ER-positive, HER2-negative early breast cancer in Japanese postmenopausal patients. Further investigations are required to confirm the prognostic value of the ROR score in Asian populations.

Our study contributes new insights into biomarker utility for identifying suitable TNBC therapies and the intercorrelations between genomic, transcriptomic, protein, and cellular biomarkers. Additionally, our rich data resource can be used by other researchers to explore the interplay between DNA, RNA, and protein biomarkers in TNBC.

Furthermore, we uncovered that the expression patterns of novel and annotated lncRNAs identified in breast cancer were related to the hormone response in the PAM50 subtyping criterion, as well as the immune response and progression states of breast cancer across different immune cells and immune checkpoint genes. Collectively, the comprehensive identification and functional analysis of lncRNAs revealed that these lncRNAs play an essential role in breast cancer by altering gene expression and participating in the regulatory networks, contributing to a better insight into breast cancer heterogeneity and potential avenues for therapeutic intervention.

P2; Recruiting --> Active, not recruiting

In summary, we could prove the clinical validity of most transcriptomic-based risk classifiers and their superiority over clinical and immunohistochemical-based methods in the heterogenous, real-world node-negative HR+HER2- MPBCS cohort.

Our investigation has unveiled many new genes predisposing individuals to ERBB2-driven cancer. Translational findings indicate that hTSGS holds promise as a biomarker for refining treatment strategies for patients with BC.

Adding ipatasertib to paclitaxel did not improve efficacy in PIK3CA/AKT1/PTEN-altered advanced TNBC. Biomarkers for benefit from PI3K/AKT pathway inhibition in TNBC remain poorly understood.

Our processing pipeline offers a reliable method for assessing spinal cord compression in DCM patients. Normalized spinal cord morphometrics, particularly the CSA could have potential for monitoring DCM disease severity and progression, guiding treatment decisions. Furthermore, to our knowledge our study is the first to apply the generic spinal cord acquisition protocol, ensuring consistent imaging across different MRI scanners and settings. Coupled with our semi-automated analysis pipeline, this protocol is key for the detailed morphometric characterization of compressed spinal cords in patients with DCM, a disease that is both complex and heterogenous. This study was funded by the National Institute of Neurological Disorders and Stroke (NINDS) (K23:NS091430) and (R01: NS129852-01A1).

Adding pertuzumab to neoadjuvant TCH does not significantly correlate with pCR in HER2E. Despite this lack of pCR improvement HER2E pts treated with TCHP showed better EFS irrespective of pathological response. EFS pertuzumab benefit was only observed in stage III or N(+) HER2E pts.

Although tamoxifen therapy is an essential treatment, the long-term benefit for patients with luminal A and B subtype is not well understood. Secondary analysis of 952 ER-positive/HER2-negative patients with luminal A or B molecular subtype from the Stockholm Tamoxifen 2, 3 and 5 trials randomized to receive tamoxifen therapy (tamoxifen alone or with goserelin) or control. Our findings suggest a long-term benefit from tamoxifen for most patients with less aggressive tumor characteristics irrespective of molecular subtype, but the benefit differed by menopausal status. Luminal B patients with PR-positive, lymph node-negative or low genomic risk tumors had a higher risk as compared to patients with luminal A tumors.

Studies on first generation antibody-drug conjugates such as trastuzumab emtansine (T-DM1) showed equal or slightly lesser efficacy than chemotherapy combined with dual HER2 blockade...A total of 370 patients with non-metastatic HER2-positive breast cancer and an indication for neoadjuvant therapy will be included and randomized 1:1 to receive either i) a taxane, carboplatin, trastuzumab and pertuzumab for three cycles or ii) T-DXd for three cycles...Estrogen receptor (ER) positive and luminal (approx 25%) patients receive trastuzumab and pertuzumab for three cycles, combined with letrozole and ribociclib for two cycles. ER-negative and luminal or basal-like (approx 10%) patients either continue with the same treatment for three more cycles in case of radiologic complete response, or in case of no complete response they receive four cycles of dose-dense epirubicin and cyclophosphamide...Key secondary endpoints are rates of complete radiologic response at three cycles; rates of pCR at the other two molecular groups and the two groups of the initial randomization; and event-free survival, defined as the time from randomization to disease progression, locoregional or distant recurrence, contralateral BC, or death due to any cause. First patient was randomized on 26th October 2023.

ROR-PR and the 21-gene RSR differentially emphasize estrogen-related and proliferative biology. The emphasis of 21-gene RS on estrogen-related biology and lower endocrine therapy initiation among Black women may contribute to poorer prognostic ability in heterogeneously treated populations.

Higher Decipher scores were associated with nonlocalized disease identified on PSMA PET/CT both pretreatment and post-RP. There were several transcriptomic differences between localized and nonlocalized diseases in both settings.

This study examines the biological effects of palbociclib and ribociclib in hormone receptor-positive breast cancer, pivotal to the HARMONIA prospective phase III clinical trial. At 2 weeks of treatment, both drugs significantly reduced the HER2-enriched signature, but at surgery, this reduction was consistent only with ribociclib. Our findings suggest that while both CDK4/6 inhibitors effectively modulate key biological pathways in HR+/HER2- breast cancer, nuances in their impact, particularly on the HER2-enriched signature, are dose-dependent, influenced by the addition of fulvestrant and warrant further investigation.

P2; N=200; Not yet recruiting; Sponsor:MedSIR

CAV1 gene expression in TNBC is a biomarker that merits further investigation in clinical trials and as a therapeutic target.

P3; In PALLET (n = 224), a 69% agreement was observed between results from PAM50 and AIMS. Different IBCMS methods may lead to different results and could misguide treatment selection; hence, a standardized clinical PAM50 assay and computational approach should be used.Trial number: NCT01740427.