A 70-GENE BREAST CANCER RECURRENCE ASSAY
Uses a Microarray gene expression profiling with a 70-gene breast cancer signature on surgically resected breast cancer tissue to classify tumors with a good or a poor prognosis.
MINDACT is a prospective, randomized, phase III, controlled clinical trial that investigates the clinical utility of MammaPrint, when compared to standard clinical pathological criteria, for the selection of patients unlikely to benefit from adjuvant chemotherapy.
From 2007 to 2011, 6,693 women who had undergone surgery for early-stage breast cancer enrolled in the trial, across 112 centers in nine countries.
In the first ever prospective clinical study for a breast cancer recurrence assay, RASTER (MicroarRAy PrognoSTics in Breast CancER) confirmed the utility of the MammaPrint 70-gene signature to identify those breast cancer patients that may safely forgo chemotherapy.
Compared to standard clincopathological classification, MammaPrint re-stratified 20% of Clinical High Risk patients to Low risk.
97% of this Low Risk patient group which primarily chose to forgo chemotherapy, were disease free at 5 years.
The TRANSBIG study showed that patients classified as Low Risk had a 10% chance of recurrence and those classified as High Risk had a 29% chance of recurrence, without adjuvant treatment at 10 years.
Generally poor prognosis is predictive of benefit from chemotherapy and good prognosis is not.