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Indiana University, Paradigm Conducting Trial Using NGS to Direct Therapy for TNBC Patients

The last paragraph of this article has been corrected to note that the $150 million in funding is in support of the Strategic Research Initiative.

NEW YORK (GenomeWeb) – Researchers at Indiana University have announced the launch of a new study in which they will use targeted sequencing provided by testing firm Paradigm to try to direct personalized treatment strategies for women with triple-negative breast cancer (TNBC) in the hopes of extending their lives.

Study investigators, led by IU's Bryan Schneider and Milan Radovich, will enroll 130 women with TNBC who are at high risk of relapse after treatment with chemotherapy and surgery. Half the women in the trial will receive standard of care, while the other half will receive a treatment based on genomic markers that researchers believe are driving patients' disease and that they have identified with the help of a targeted sequencing test.

"In this group, we will use our understanding of genomics to identify the gas pedal for each woman's specific cancer and see if we can find a drug that will block the gas pedal in a way that is better than non-specific chemotherapies," Radovich, an assistant professor of surgery and molecular genetics at IU, said in statement.

Paradigm, a nonprofit genomic sequencing and molecular information analysis firm, will use next-generation sequencing to analyze the tumor profiles of the study participants after they receive chemo. IU researchers will discuss the gene mutations and overly expressed genes identified by Paradigm, and then will assign women in the sequencing arm to a drug that they are likely to respond to best based on available published data.

The Hoosier Cancer Research Network will manage the trial, which is open to women with stage I to III invasive TNBC who have completed preoperative chemo and surgery to remove their primary tumor, but who have significant residual disease at the time of surgery.

"This trial is one of only a handful in the world that tests, through a controlled scientific study, whether the use of next-generation sequencing to identify specific disease drivers – and the selection of treatments for women based on those genetic markers – actually improves survival rates for women," said Paradigm CEO Robert Penny in a statement.

This trial is being funded by the Vera Bradley Foundation for Breast Cancer, the Walther Cancer Foundation, and the Strategic Research Initiative, which is a $150 million, five-year research collaboration of the IU School of Medicine and Indiana University Health.