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Published on: May 17, 2019
SYNTHESIS-Breast: A prospective early-phase trial of a genetic-interaction- focused computational algorithm in
Aanika B Warner1, Britanny B Solarz1, Miroslava Belyov1
1National Cancer Institute.
Abstract:
SYNTHESIS-Breast is an exploratory trial that adapts early-phase design to identify off-label therapies in metastatic breast cancer via ENLIGHT, a retrospectively validated computational algorithm, and generate preliminary data for future trials. ENLIGHT selects treatments via gene-expression-based synthetic lethality/rescue. SYNTHESIS-Breast's design includes algorithm-specific adaptations (ex. a reproducible molecular tumor board or layered Simon two-stages for fast interim checkpoints). SYNTHESIS-Breast will not only guide ENLIGHT applications, but also future prospective algorithm trials.
Insights
This study explores off-label therapies for metastatic breast cancer using the ENLIGHT computational algorithm. It aims to generate data for future trials by identifying gene-expression-based treatments.
Area of Science:
- Oncology
- Computational Biology
- Genomics
Background:
- Metastatic breast cancer presents challenges for treatment selection.
- Identifying novel, off-label therapeutic strategies is crucial.
- Computational algorithms offer potential for personalized treatment discovery.
Purpose of the Study:
- To adapt early-phase trial designs for identifying off-label therapies in metastatic breast cancer.
- To utilize the ENLIGHT computational algorithm for treatment selection based on gene expression.
- To generate preliminary data to inform future prospective trials.
Main Methods:
- An exploratory trial design adapted for early-phase research.
- Application of the ENLIGHT algorithm, which selects treatments via gene-expression-based synthetic lethality/rescue.
- Inclusion of algorithm-specific adaptations such as a molecular tumor board and layered Simon two-stage designs.
Main Results:
- The study is designed to identify potential off-label therapies.
- Preliminary data will be generated for future clinical trials.
- The ENLIGHT algorithm's application in a clinical trial setting will be evaluated.
Conclusions:
- The SYNTHESIS-Breast trial will guide the application of the ENLIGHT algorithm.
- This approach will facilitate future prospective trials for algorithm-driven cancer therapies.
- The study contributes to advancing personalized medicine in metastatic breast cancer.