Using Genetic Data For Developing Personalized Cancer Therapies

Indiana University researchers launched a new study to create personalized therapy for patients with triple-negative breast cancer based on genetic data. According to researchers, risk stratification was made possible by building upon previous findings by the team.

PERSEVERE is a phase 2 clinical trial set to develop personalized cancer treatment combinations compared to standard cancer treatment.

“There is a tremendous need for successful triple-negative breast cancer treatments,” leader of the study Bryan P. Schneider, MD, said in a press release. “Recurrence and death rates are still too high, and novel strategies to improve that are markedly needed. We feel PERSEVERE is an innovative trial to try to help meet those needs.”

While about one-third of patients with triple-negative breast cancer achieve remission after surgery and chemotherapy, two-thirds remain with cancerous tissue in their bodies. In addition, recent research indicates that patients who test positive for circulating tumor DNA (ctDNA) after surgery are at higher risk of cancer returning.

PERSEVERE clinical trial will enroll 200 participants and test whether there is ctDNA in their blood. If an individual tests positive for ctDNA, the researchers will examine their blood and tumor DNA to determine any genetic differences that could be treated with a genomically targeted therapy or a standard treatment.

If the patient tests positive for ctDNA and researchers find they do not have a specific genome target in their blood or cancer tissue, she will receive the standard treatment recommended by her doctor. Those who test negative for ctDNA will also receive standard treatment. However, they will also have the choice to receive no treatment and remain in the study for observation.

“Based on the data that came out of our group, we have shown that circulating tumor DNA is also a very powerful risk stratifier,” said Schneider, who is also the Vera Bradley Professor of Oncology at IU School of Medicine and a physician-scientist at the IU Melvin and Bren Simon Comprehensive Cancer Center and the Vera Bradley Foundation Center for Breast Cancer Research.

“In this trial, we’ll capitalize on that powerful ability to better focus our attention on novel therapies for those patients at extraordinarily high risk who have ctDNA positivity. Equally importantly, it will provide the opportunity for us to focus on those who do not test positive for ctDNA, a group that may be expected to do quite well in terms of de-escalating therapy and improving quality of life.” 

PERSEVERE builds on the previous research by Schneider and his colleagues. They discovered the presence of ctDNA and circulating tumor cells (CTCs) in the plasma of women’s blood who underwent chemotherapy before surgery for triple-negative breast cancer treatment could be a prediction method for disease recurrence.

The research team will follow up with participants for up to five years to check for side effects as well as cancer recurrence. According to the press release, researchers hope the study can determine better treatments for those fighting triple-negative breast cancer by examining genetic data.