MammaPrint®

Unbiased Development for an Objective, Binary Result

MammaPrint assesses the activity of the 70-genes in tumor tissue most associated with the development of breast cancer metastasis.

By analyzing the expression level of these genes, which are isolated from a tumor biopsy, using a unique and proprietary algorithm, MammaPrint can classify the patient as being at either a genomic High or Low Risk of recurrence, with a genomic Low Risk indicating that there is no significant benefit from chemotherapy.

These 70 genes were identified based on unbiased evaluation of the full genome (25,000 genes) in tumor samples from untreated breast cancer patients.

Using samples from patients that were untreated, prevented any type of treatment influencing the outcome. The MammaPrint result is based on the patient’s true biology.1,2

MammaPrint does not reassess traditional breast cancer markers such as estrogen receptor and progesterone receptor status, Ki67 or HER2, which are already assessed during traditional clinicopathology assessment. The discovery of the 70 genes was completely unbiased and did not rely on current knowledge or literature; analysis of the tumor biology itself uncovered those genes most predictive of breast cancer recurrence.

Clinical Performance

Demonstrating the Clinical Utility of MammaPrint: The MINDACT Trial

The findings of MINDACT, the Microarray In Node negative or 1-3 LN+ Disease may Avoid ChemoTherapy trial3,4 were published in the peer-reviewed high-impact New England Journal of Medicine in August 2016.
A phase III, prospective randomized, controlled multicenter trial, from 2007-2011, 6,693 patients from 112 centers in nine European countries were enrolled into MINDACT.
It is the most comprehensive, large scale clinical trial of its kind to date, the only such trial to have published its full outcome for a breast cancer recurrence test and was designed to answer the question: What is the clinical utility of the addition of the MammaPrint test to standard clinical-pathological criteria in selecting patients for chemotherapy?
This primary objective was met and the positive outcome provided the highest level of evidence (1A) to support the clinical utility of MammaPrint.

Findings

Of 3,356 clinical high risk patients, 46% were reclassified as MammaPrint Low Risk and could avoid chemotherapy without significantly compromising their outcome, this provides considerable quality of life and cost effectiveness implications for these patients.
Clinically high risk patients classified by MammaPrint as genomic Low Risk patients had no statistical benefit of chemotherapy with a 94.7% five-year Distant Metastasis Free Survival (DMFS) without chemotherapy.
Patients with 1-3 affected lymph nodes who would usually be classified as clinical high risk and automatically treated with chemotherapy were reclassified by MammaPrint as Low Risk with excellent five-year survival of 95.6%.

References

  1. Van ‘t Veer L., Nature 2002; 415 (31) : 530-536
  2. Van de Vijver MJ, N Engl J Med 2002; 347 (24): 1999-2009
  3. Cardoso F. N Engl J Med 2016; 375: 715-729
  4. Hudis CA. N Engl J Med 2016; 375: 790-791