Prospective neo-adjuvant REGISTRY trial linking MammaPrint, Subtyping and treatment response: Neoadjuvant Breast Registry - Symphony™ Trial (NBRST) (pronounced “in breast”)

Study design

This is a prospective observational, case-only, study linking MammaPrint, BluePrint, TargetPrint, TheraPrint and possible additional profiles of interest to treatment response, Recurrence Free Survival (RFS) and Distant Metastases Free Survival (DMFS). 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 by 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.

Study population

Inclusion criteria:

• Women with histologically proven breast cancer, who have started or are scheduled to start neo-adjuvant chemotherapy therapy or neo-adjuvant hormone therapy, after successful MammaPrint assay
• Age 18-90
• Written informed consent

Exclusion Criteria:

• Patients who have had excisional biopsy or axillary dissection
• Patients with confirmed distant metastatic disease
• Patients who have had any prior chemotherapy, radiotherapy, or endocrine therapy for the treatment of breast cancer
• Any serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease

Participating NBRST Centers

For participating centers please visit clinicaltrials.gov