MammaPrint and BluePrint Cost-effective and Beneficial Across Breast Cancer Patient Populations

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New data will be be presented during the upcoming San Antonio Breast Cancer Symposium (SABCS), being held at the Henry B. Gonzales Convention Center in San Antonio, Texas from December 5-9, 2017, highlighting the value of the MammaPrint? 70-Gene Breast Cancer Risk-of-Recurrence Test and the BluePrint? Breast Cancer Molecular Subtyping Test.

MammaPrint, distributed by The Netherlands-based Agendia, world leader in personalized medicine and molecular cancer diagnosticsis, is an in vitro diagnostic test, performed in a central laboratory, using the gene expression profile of breast cancer tissue samples to assess a patients? risk for distant metastasis.

The test, cleared by the U.S. Food and Druf Administration (FDA), and approved for use in the? European Union, is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. The test is not intended to determine the outcome of disease, nor to suggest or infer an individual patient?s response to therapy.

Development of a Predictive test
In developing Mammaprint, Rene Bernards Ph.D and Laura van?t Veer Ph.D, cancer researchers working for the ‘Netherlands Cancer Institute’ (NKI) in Amsterdam, The Netherlands, tried to answer the age old clinical? question in the management of breast cancer patients: ‘Which patient is at risk for recurrence?

The answer to this question helps physicians make decisions about adjuvant treatment for chemotherapy are primarily.

Bernard and Van ‘t Veer hypothesized that since breast cancer is a heterogeneous?disease, gene expression should be different in High Risk?breast tumors that may benefit from adjuvant chemotherapy vs.?those that are Low Risk?and would likely not see?any benefit from adjuvant chemotherapy.

To confirm their hypothesis, tumor specimens from 78 untreated breast cancer patients with known outcomes were analyzed. ?The entire human genome was interrogated to determine which genes were most predictive of recurrence at five years. ?As a result, the 70 most significant genes predictive of recurrence risk were identified. This unbiased gene selection method, helped the researchers confirm which genes were most predictive.

I-SPY 2 and IMPACt trial
The posters and presentations feature important new data from the I-SPY 2 trial (Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer) and the IMPACt trial (Measuring the Impact of MammaPrint on Adjuvant and Neoadjuvant Treatment in Breast Cancer Patients: A Prospective Registry) as well as cost-effectiveness data and performance data across patient populations of different ages, and those affected by obesity and other metabolic factors.

An oral presentation on Thursday, December 7 will show the first long-term survival results from the I-SPY 2 trial for patients pre-selected by MammaPrint.


Rene Bernards, PhD, co-developer of MammaPrint? discusses how breast cancer biology drove the discovery of the 70-Gene Breast Cancer Recurrence Assay


?The breadth and depth of the new data being presented at SABCS clearly demonstrates the broad application of MammaPrint and BluePrint in helping to guide breast cancer treatment decisions in a wide range of patient populations,” noted William Audeh, MD, Chief Medical Officer at Agendia.

“In addition, it underscores the important role that MammaPrint can take in clinical trials like I-SPY 2. Physicians and their patients want to feel confident that they are using the test that is backed with the highest level of clinical evidence and the most comprehensive data, and MammaPrint can provide this reassurance,? Audeh.


?Wednesday, December 6, 2017
?PosterTitleLocation/Time
P1-02-05The effect of obesity and metabolic factors on genomic assays for risk of recurrence.Hall 1, 17:00 ? 19:00 CST Poster Session 1.
P1-07-08Young age and the risk of disease recurrence as assessed by the 70-gene signature ? an analysis from the EORTC10041/BIG 03-04 MINDACT trialHall 1, 17:00 ? 19:00 CST
Poster Session 1.

Thursday, December 7, 2017
Session/PosterTitleLocation/Time
P2-09-19Genomic biomarker for resistance to Palbociclib in the NeoPalAna TrialHall 1, 07:00 ? 09:00 CST Poster Session 2.
P2-09-08Analysis of biomarkers for response and resistance to the AKT inhibitor MK-2206 in the neoadjuvant I-SPY 2 trial for stage II-III high-risk breast cancerHall 1, 07:00 ? 09:00 CST Poster Session 2.
Oral Session GS3-08Pathological complete response predicts event-free and distant disease-free survival in the I-SPY2 TRIALHall 3, 11:15, 09:30 ? 11:30 CST General Session 3.
Discussion PD6-08Analysis of immune infiltrates (assessed via multiplex fluorescence immunohistochemistry) and immune gene expression signatures as predictors of response to the checkpoint inhibitorStars at Night Ballroom 3 & 4, 17:00 ? 19:00 CST Immuno Oncology.
Discussion PD6-14Analysis of DNA repair deficiency biomarkers as predictors of response to the PD1 inhibitor pembrolizumab: Results from the neoadjuvant I-SPY 2 TRIAL for Stage II-III high-risk breast cancerStars at Night Ballroom 3 & 4, 17:00 ? 19:00 CST Immuno Oncology.

Friday, December 8, 2017
PosterTitleLocation/Time
?P4-12-01MammaPrint is cost-effective compared to clinical risk assessment in early stage breast cancerHall 1, 07:00 ? 09:00 Poster Session

Saturday, December 9, 2017
PosterTitleLocation/Time
P6-13-04IMPACt Trial: MammaPrint and BluePrint molecular subtyping guide treatment decisions in Breast CancerHall 1, 07:00 ? 09:00 Poster Session 6.
P6-13-06A community based study utilizing the 70-gene signature (MammaPrint) for treatment decisions in elderly patientsHall 1, 07:00 ? 09:00 Poster Session 6.
P6-15-07Pathologic Complete Response (pCR) in Locally Advanced Triple Negative (TN) and HER2+ (HER2+) Breast Cancer (BC) Treated with Anthracycline-Free Neoadjuvant Therapies and Associations with Gene Expression (GE) Patterns, Tandem Repeats (TR), and Intratumoral Cellular CompositionsHall 1, 07:00 ? 09:00 Poster Session 6.

Last Editorial Review: November 30, 2017

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