NBRST: Prospective Neo-adjuvant REGISTRY Trial
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The scope of this registry study is to measure chemosensitivity as defined by pCR (primary
      endpoint), or endocrine sensitivity as defined by partial response (decrease in longest tumor
      diameter or residual cancer burden category 1 (RCB1), a primary endpoint for neo-adjuvant
      endocrine therapy and a secondary endpoint for neoadjuvant chemotherapy), metastasis-free
      survival and relapse-free survival(secondary endpoints) in molecular subgroups, determined by
      the established MammaPrint, BluePrint, Targetprint and Theraprint profiles in addition to
      possible novel expression profiles.
    

Detailed description: 
      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 50-70 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 1000 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.
    

Intervention name(s): MammaPrint 70-gene expression profile; BluePrint 80 gene expression profile
Intervention type(s): Other; Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with histologically proven breast cancer, who have started or are scheduled to start
        neo-adjuvant chemotherapy therapy or neo-adjuvant hormone therapy.
      
Biospecimen description: 
      As part of routine breast cancer treatment, the doctor will conduct a core needle biopsy and
      provide tissue from the tumor to Agendia for testing. After the diagnostic test(s) from the
      Agendia Breast Cancer Suite have been performed on the tumor specimen, there might be some
      remaining tissue left.
    
Keywords: neo adjuvant, breast cancer