Evaluate the rapid genomic characterization of patient samples for the “druggable” genome.
Lead Principal investigators:
Clinical Trial Leader – Lillian Siu (University Health Network)
Genomics Platform Leader – John McPherson (OICR Genome Technologies Platform)
Sequenom Platform Leader – Suzanne Kamel-Reid (University Health Network)
Janet Dancey, Lincoln Stein, Sangeet Ghai, Pat Shaw
Lead clinical investigators:
Eric Winquist (London), Sebastien Hotte (Hamilton), Glenwood Goss
Objective: to demonstrate a model of rapid genomic characterization of patient samples for the “druggable” genome.
- Demonstrate and optimize the processes and procedures required for assuring adequate specimen collection for sequencing the broad numbers of genes in the cancer genome;
- Validate the occurrence of “actionable” genetic abnormalities (defined as those having the potential to impact on treatment recommendations for predictive or prognostic reasons, or those with known prognostic or diagnostic implications) in a clinical molecular diagnostics laboratory;
- Develop the tools to report “actionable” mutations (those that inform medical decisions) to clinicians and patients for treatment or trial recommendations;
- Develop the databases for clinical, pathological and genomic data collection and integration;
- Preliminarily assess the comparability of archived diagnostic formalin-fixed paraffin-embedded (FFPE) and fresh tumour biopsy tissues.
Lead Principal Investigator:
Mark Levine, McMaster University
Dr. John Bartlett, Ontario Institute for Cancer Research
Dr. Murray Krahn, University of Toronto
The general objective is to address the overtreatment of early stage breast cancer by identifying a group of good prognosis patients that can be spared adjuvant chemotherapy.
In patients with ER+ N− breast cancer who are receiving (or will receive) endocrine therapy, to compare the OncotypeDX test, the current standard, with PAM50, Mammostrat and IHC4 tests in identifying those with a low risk of recurrence.
In patients with ER+ N− breast cancer who are receiving (or will receive) endocrine therapy:
1. To compare the OncotypeDX test, the current standard, with PAM50, Mammostrat and IHC4 tests in identifying
those with a high risk of recurrence.
2. To assess the correlation between the biomarker assay quantitative scores (OncotypeDX, Mammostrat, PAM50
3. To conduct an economic analysis on the utility of the various biomarkers (OncotypeDX, PAM50, Mammostrat and IHC4) to guide the use of adjuvant therapy.