Prospective Neo-adjuvant REGISTRY Trial Linking MammaPrint, Subtyping and Treatment Response: Neoadjuvant Breast Registry - Symphony Trial (NBRST) (Pronounced "in Breast")

Trial Information

Prospective Neo-adjuvant REGISTRY Trial Linking MammaPrint, Subtyping and Treatment Response: Neoadjuvant Breast Registry - Symphony Trial (NBRST) (Pronounced "in Breast")

This will be a prospective observational, case-only study linking MammaPrint, BluePrint,
TargetPrint, TheraPrint and possible additional profiles of interest to treatment response
and Distant Metastases Free Survival (DMFS) and Relapse Free Survival (RFS). Only patients
who receive neo-adjuvant therapy can participate.

For this project, approximately 20-30 institutions in the US will be invited to contribute
clinical patient data from enrolled patients after a MammaPrint, TargetPrint, BluePrint and
TheraPrint test has been successfully performed and the patient has started neo-adjuvant
therapy.

Treatment is at the discretion of the physician, adhering to NCCN approved regimens or a
recognized alternative.

The clinical data is to be entered online at 4 time points; amounting to four Case Report
Forms (CRFs). Data will be collected on an ongoing basis, the first CRF must be completed
within 6 weeks after the MammaPrint, BluePrint, TargetPrint, and TheraPrint result was
provided. The second CRF should be completed 4 weeks after definitive surgery. CRF 3 and
CRF4 will be completed 2-3 and 5 years after surgery.

It is expected that we will enroll around 500 patients in 4 years.

OBJECTIVES

- Measure chemosensitivity (as defined by pCR) or endocrine sensitivity (as defined by
decrease in longest tumor diameter or RCB1)in the molecular subgroups as determined by
combining MammaPrint and BluePrint results.

- Correlate chemosensitivity (as defined by pCR) to TheraPrint Therapy Gene Assay
results.

- Compare local IHC and FISH results (if available) with TargetPrint results. Compare the
three BluePrint molecular subgroups with IHC-based subtype classification.

- Document impact of MammaPrint, TargetPrint and BluePrint result on treatment decision.

- Assess the 2-3 and 5 years DMFS and RFS for the different molecular subgroups.

- Measure chemosensitivity or endocrine sensitivity correlation with novel expression
profiles.