Providing Unparalleled Insights into Individualized Therapy for Breast Cancer Patients

About the MINDACT Breast Cancer Clinical Trial and MammaPrint^®

The MINDACT (Microarray In Node negative and 1-3 positive lymph node Disease may Avoid ChemoTherapy) trial is a multi-center, prospective, phase III randomized study comparing the MammaPrint 70-gene expression signature with a common clinical-pathological prognostic tool (Adjuvant! Online) in selecting patients with negative or 1-3 positive nodes for adjuvant chemotherapy in breast cancer.

To date, over 5,942 breast cancer patients have been registered and over 3,142 patients enrolled from 93 participating institutions in 9 European Countries. The goal is to complete enrollment of 6,000 breast cancer patients by late 2011.

In the MINDACT trial, women with breast cancer who are assessed as “High Risk” by both MammaPrint and clinical-pathologic guidelines are advised to have chemotherapy whereas for women with “Low Risk” concordance, hormonal therapy alone is recommended.  However, discordant cases are randomized to receive either chemotherapy or hormonal therapy based on clinical-pathological risk assessment or MammaPrint and the patients are followed.  It is anticipated that the results of MINDACT will validate MammaPrint as an important prognostic and predictive tool in cancer treatment.

Primary objectives of the MINDACT trial are:

• To confirm that breast cancer patients with a “low risk” molecular prognosis by MammaPrint and “high risk” clinical prognosis can be safely spared chemotherapy without affecting Distant Metastases Free Survival (DMFS).
• To compare anthracycline-based chemotherapy regimens to a docetaxel-capecitabine regimen which may be associated with increased efficacy and reduced long-term toxicities for women with breast cancer.
• To compare the efficacy and safety of 7 years of single agent Letrozole to the sequential strategy of 2 years of Tamoxifen followed by 5 years of Letrozole (Randomization Endocrine therapy).