Reliance on hormone Not required can reliably Tamoxifen only otherwise – therapy use Tamoxifen, Anastrozole, utilise risk prediction can’t Letrozole or other hormonal agents & retain risk prediction Prospective studies One - RASTER Nil completed Sample type FFPE or Fresh FFPE Country of origin Holland USA Location of laboratories 2 USA & Holland. 1 - USA – Utility in I SPY 2 & I SPY Yes No 3 drug selection trials T size Any Any N status N- / N+ (1-3) N- / N+ (1-3) ER status Positive or Negative Positive Grade Any Any Proven utility with HER2 Yes (Knauer 2010) No Predictive Data 1696 patients 651 patients (Straver 2009, Knauer 2010) (Gianni 2005, Paik 2006) Expected health outcomes relating to the medical service A. Identify the expected patient-relevant health outcomes if the service is recommended for public funding, including primary effectiveness (improvement in function, relief of pain) and secondary effectiveness (length of hospital stays, time to return to daily activities). MammaPrint is expected to influence outcomes in two ways: 1. By reducing exposure to adverse event causing chemotherapies in those patient populations in whom chemotherapy is less likely to offer a survival benefit; and, 2. By increasing chemotherapy use in those patient populations in which chemotherapy is more likely confer a survival benefit.
Reliance on hormone therapy Not required – can reliably use Tamoxifen, Anastrozole, Letrozole or other hormonal agents & retain risk prediction Tamoxifen only otherwise can’t utilise risk prediction Prospective studies completed One - RASTER Nil Sample type FFPE or Fresh FFPE Country of origin Holland USA Location of laboratories 2 – USA & Holland. 1 - USA Utility in I SPY 2 & I SPY 3 drug selection trials Yes No T size Any Any N status N- / N+ (1-3) N- / N+ (1-3) ER status Positive or Negative Positive Grade Any Any Proven utility with HER2 Yes (Knauer 2010) No Predictive Data 1696 patients (Straver 2009, Knauer 2010) 651 patients (Gianni 2005, Paik 2006) Expected health outcomes relating to the medical service A. Identify the expected patient-relevant health outcomes if the service is recommended for public funding, including primary effectiveness (improvement in function, relief of pain) and secondary effectiveness (length of hospital stays, time to return to daily activities). MammaPrint is expected to influence outcomes in two ways: 1. By reducing exposure to adverse event causing chemotherapies in those patient populations in whom chemotherapy is less likely to offer a survival benefit; and, 2. By increasing chemotherapy use in those patient populations in which chemotherapy is more likely confer a survival benefit.
1376-ApplicantConsultationProtocol-accessible.docx