TEST:

MammaPrint

In conclusion, HR+/MP-H2 cancers closely resemble TN breast cancers in transcriptional and clinical features and benefit from similar treatment strategies.

The prognostic performance of MammaPrint was demonstrated in early-stage clinically intermediate to high-risk BC patients. Moreover, patients with MammaPrint Low Risk tumors had good outcome regardless of treatment regimen, thus supporting personalized treatment choices.

Online score. In conclusion, high CIN is an independent prognostic indicator for HR+/HER2- breast cancer with shorter iDFS and OS and holds promise for predicting recurrence and metastasis.

(early data and active trial) Who may benefit from the addition of anthracycline to their chemotherapy regimen (AC-T/TC)? Who may benefit from extended endocrine therapy?

(early data and active trial) Who may benefit from the addition of anthracycline to their chemotherapy regimen (AC-T/TC)? Who may benefit from extended endocrine therapy?

P3; In conclusion, although the number of randomized patients is small, patients with small, genomic high-risk breast cancer did not seem to derive benefit from chemotherapy. Endocrine therapy was associated with improved outcomes even in genomic low-risk breast cancers.

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Among patients with high molecular-risk HR+/HER2- EBC, the MP-High2, BP-Basal-type, and ImPrint positive signatures identified a partially overlapping subset of patients who were more likely to achieve pCR in response to neoadjuvant chemotherapy +/- targeted agents or immunotherapy compared to patients with MP-High1, BP-Luminal-type, and ImPrint negative disease. I-SPY2.2 is incorporating the use of these biomarkers to molecularly define specific patient populations and optimize treatment selection.

Participants must not have received any prior treatment for their current breast cancer, including chemotherapy, immunotherapy, biologic, or hormonal therapy, and must be candidates for doxorubicin, paclitaxel, and durvalumab therapy. No participants are currently ineligible. There have been no Grade 4 or higher adverse events reported among the 26 participants assessed for adverse events.

In patients with early-stage ER+ breast cancer with a disputable chemotherapy indication it is sensible to deploy the 70-GS to better select patients for adjuvant chemotherapy.

This paper reviews evidence for several genomic tests, including Oncotype DX, MammaPrint, Breast Cancer Index, RucurIndex, and EndoPredict, which assist in tailoring adjuvant therapy. Additionally, we explore the role of liquid biopsies in personalizing treatment, emphasizing the importance of considering late relapse risks and potential benefits of extended systemic therapy for HR+/HER2- breast cancer patients.

"Agendia, Inc. today announced that it has obtained certification from the European Union (EU) In Vitro Diagnostic Medical Device Regulation (IVDR) for three products, including its MammaPrint FFPE Microarray, BluePrint FFPE Microarray, and MammaPrint and BluePrint NGS Kit. These products are classified as Class C under this regulation."

P2; Recruiting --> Active, not recruiting

P=N/A; Trial completion date: Apr 2026 --> Apr 2030 | Trial primary completion date: Apr 2024 --> Apr 2028

P3 | N=3966 | "Agendia, Inc. today announced that the NSABP B-42 study evaluating the MammaPrint assay in predicting the benefit of extended endocrine therapy (EET) in early-stage breast cancer patients was published in the July issue of Journal of Clinical Oncology.... The data revealed that only MammaPrint Low (non-UltraLow) Risk tumors showed a statistically significant 10-year EET benefit of 9.5% for disease-free survival (DFS) and 7.9% for breast cancer-free interval (BCFI). Conversely, MammaPrint UltraLow and High Risk tumors did not derive statistically significant EET benefit."

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.

The primary hypothesis of predictive ability of MP on DR was not confirmed. However, the secondary outcomes demonstrated MP was predictive of ELT response and identified a subset of patients with early-stage hormone receptor-positive BC (MP-LR) with improved outcomes from ELT. These data could have important clinical implications in patient selection beyond clinical risk assessment for EET.

MammaPrint and BluePrint classification highlights racial disparities in the distribution of distinct High Risk molecular subtypes among HR+HER2- early BC. However, survival at 3 years was driven by molecular subtype, independent of race, after controlling for potential confounders. These data highlight the importance of tumor genomic testing to inform treatment decisions as we strive to reduce racial survival disparities among Black females with BC.

Having MP on CNB does not provide clinically meaningful information about the pN stage and does not further refine which BC patients within CW could benefit from escalation to SLN or delineate a group more likely to be pathologically node-negative.

Neo-CheckRay (NCT03875573) is the first prospective, international, phase 2, randomized trial investigating this treatment. Eligible patients (pts) with newly diagnosed cT1c-3 (≥ 2 cm) cN0 or cT1c-3 (≥ 1.5 cm) cN1-3, grade 2 (Ki67 ≥ 15%) or grade 3, MammaPrint (MP) high risk, invasive ER+/HER2- BC were randomized 1:1:1 to arm 1: neo-adjuvant paclitaxel q1w x12 with SBRT at week 5 (3x8 Gy targeting the primary tumour, avoiding lymph nodes and normal breast tissue), followed by dose-dense epirubicin/cyclophosphamide q2w x4; arm 2: arm 1 + durva 1500mg q4w x5; and arm 3: arm 2 + ole 3000 mg q2w x4 then q4w x3. The addition of durva+/- ole numerically increases pCR and RCB 0/1 rates compared to NACT+SBRT. Final statistical analysis will be presented at the conference. Ongoing translational research will shed light on the mechanisms of response.

The multidisciplinary breast cancer team recommended NAT with pembrolizumab, carboplatin, paclitaxel, doxorubicin, and cyclophosphamide. This case underscores the potential benefits of neoadjuvant chemoimmunotherapy for patients with ER+ErbB2- high-risk, basal-type breast cancer. The use of immunotherapy in patients with pregnancy-associated breast cancer remains to be further investigated.

Chemotherapy was indicated for those who would not receive it before. It was contraindicated in patients who would previously undergo chemotherapy.

Sponsored by Agendia NV

Early-stage HR-positive breast carcinomas have low TIL levels regardless of the recurrence risk, molecular subtype, and HER2- low status. These cancers are markedly enriched by HER2-low phenotype, which might have therapeutic implications due to the recently approved anti-HER2 antibody-drug conjugate.

In addition, the combination of TS-1 and Abemaciclib is currently the standard treatment, and new consideration is needed regarding the additional effect of anthracycline and taxane drugs using PREDICT and Oncotype Dx. Conclusion PREDICT alone may lead to underestimation or overestimation of the additional effect of anticancer drug treatment, and it is important to combine risk assessment with tools such as Oncotype Dx

This systematic review builds upon prior reviews, with a focus on five widely commercialized GEAs (Breast Cancer Index®, EndoPredict®, MammaPrint®, Oncotype DX®, and Prosigna®). The comprehensive dataset available provides a contemporary opportunity to assess each GEA's utility as a prognosticator and/or predictor of adjuvant therapy benefit.

Among these tests, Prosigna and EndoPredict® have at present been validated only on a prognostic level, while Oncotype Dx, MammaPrint, and BCI hold both a prognostic and predictive role. Oncologists and pathologists engaged in the management of EBC will find in this review a thorough comparison of available genomic assays, as well as strategies to optimize the utilization of the information derived from them.

In second-line advanced breast cancer, in addition, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) and estrogen receptor 1 (ESR1) should be tested in hormone-sensitive cases, BRCA gene mutations in HER2-negative cancers, and in triple-negative breast cancer (TNBC), programmed cell death-1 ligand (PD-L1). Newer biomarkers and technologies, including tumor-infiltrating lymphocytes (TILs), homologous recombination deficiency (HRD) testing, serine/threonine kinase (AKT) pathway activation, and next-generation sequencing (NGS), are at this point investigational.

P2 | N=28 | Recruiting | Sponsor: University of Illinois at Chicago | Not yet recruiting ➔ Recruiting

P2 | N=28 | Not yet recruiting | Sponsor: University of Illinois at Chicago

P=Obs | N=2, 5000 | FLEX (NCT03053193) | Sponsor: Agendia | "Agendia, Inc. today announced it will present new data characterizing the immune biology of MammaPrint High Risk tumors in an oral session at the 2024 Annual American Society of Clinical Oncology (ASCO) Meeting, taking place in Chicago, IL. on June 3rd, 2024....Results of the analysis showed that MP High-2 tumors had a significantly higher frequency of antigen presenting cells (APCs) (including activated dendritic cells and macrophages, CD4+ memory T cells, CD8+ T cells, memory B cells and antibody producing plasma cells) relative to High-1 tumors, highlighting an increased immune active state in High-2 tumors. The increased antigen presentation and presence of APCs, which are critical in activating T- and B-cells, may explain why High-2 tumors display improved response rates to immunotherapy."

"Additional data supporting MammaPrint utility in treatment selection will be presented by investigators from the ISPY2 trial in a poster...By using data from the ISPY-2 trial, this poster demonstrates that MammaPrint H2 tumors have molecular and clinical similarities to triple negative breast cancer tumors, underscoring critical insight into how treatment plans can be optimized to achieve the best result for the patient."