Prospective Registry Of MammaPrint in breast cancer patients with an Intermediate recurrence Score (PROMIS)

Study Design:

This will be a prospective observational, case-only, study of MammaPrint in patients with an Oncotype DX intermediate score (18-30). The clinical data is to be entered online. There will be two Case Report Forms (CRF). The first CRF must be completed before receiving the MammaPrint result. This CRF will capture baseline patient characteristics, pathology information, Oncotype DX score and the recommended treatment plan without knowing the MammaPrint result. The second CRF will be completed within 4 weeks after receiving the MammaPrint result and will capture the recommended treatment based on MammaPrint. It is expected that approximately 20-30 institutions in the US will participate. Around 300 patients will be enrolled in 2 years.

Objectives:

This registry study has the following objectives:

•  Describe the frequency of chemotherapy + endocrine versus endocrine alone decisions in Oncotype DX intermediate score patients

•  Assess the impact of MammaPrint on chemotherapy + endocrine versus endocrine alone treatment decisions

•  Assess the distribution of MammaPrint Low and High Risk in patients with an intermediate recurrence score

•  Assess concordance of TargetPrint ER, PR and Her2 results with Oncotype DX ER, PR and Her2 and with locally assessed IHC/FISH ER, PR and Her2

• Compare clinical subtype based on IHC/FISH ER, PR, Her2 and Ki-67 (if available) with BluePrint molecular subtype

Study Population:

 Inclusion criteria:

• Women with histologically proven invasive stage I-II, node negative, hormone receptor positive, Her2 negative breast cancer, who received an Oncotype DX intermediate score (18-30)

• ≥ 18 years of age at time of consent
• Written informed consent

Exclusion Criteria:

• Insufficient tissue remaining for Mammaprint FFPE
• Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
• Women who have started or completed adjuvant chemotherapy or neo-adjuvant chemotherapy

Participating Centers:

For participating centers please visit clinicaltrials.gov