Abstract OT3-4-03: Prospective neo-adjuvant registry trial linking MammaPrint, subtyping and treatment response: Neo-adjuvant Breast Registry – Symphony Trial (NBRST)

Abstract

Abstract Background: The FDA-approved MammaPrint 70 gene profile is performed on a diagnostic multi-gene array. This platform enables additional gene expression profiles to be analyzed simultaneously on one tumor specimen. One such gene expression profile is BluePrint, an 80 gene molecular subtyping profile that discriminates between three distinctive subtypes; Basal-type, Luminal-type, and HER2-type. By combining MammaPrint and BluePrint, patients can be stratified into the following subgroups: Luminal-type/MammaPrint Low Risk; Luminal-type/MammaPrint High Risk; HER2-type and Basal-type. Marked differences are observed in response to neo-adjuvant treatment in groups stratified by MammaPrint and BluePrint [Glück et al. ASCO 2012]. Trial design: NBRST is a prospective observational, case-only study linking MammaPrint and BluePrint to neo-adjuvant treatment response and Distant Metastases-Free Survival (DMFS) and Relapse-Free Survival (RFS). MammaPrint and BluePrint are assessed on fresh or formalin-fixed, paraffin-embedded core needle biopsy samples. Treatment is at the discretion of the physician, adhering to NCCN approved regimens or a recognized alternative. Eligibility: The study will include women aged 18–90 with histologically proven breast cancer, who have started or are scheduled to start neo-adjuvant chemotherapy or neo-adjuvant hormonal therapy, after successful MammaPrint and BluePrint assessment, and who provide written informed consent. Additional inclusion criteria are that women must have had no excisional biopsy or axillary dissection, no confirmed distant metastatic disease, and no prior therapy for the treatment of breast cancer. Objectives: The main objectives of this registry study are to: 1. Measure chemosensitivity (as defined by pathological complete response [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.2. Compare local IHC and FISH results with TargetPrint results and BluePrint results.3. Document impact of MammaPrint, TargetPrint and BluePrint results on treatment decisions.4. Assess the 2–3 and 5-year DMFS and RFS for the different molecular subgroups. Statistical methods: Comparison of response rates between different molecular subgroups will be conducted using the Pearson Chi-square test. Accrual: The trial started in August 2011 and there are currently 36 participating sites in the US. To date (June 06, 2012), 158 of the planned 400 patients have been enrolled.Clinical trial registry number: NCT01479101. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr OT3-4-03.