Mason researchers launch third phase of breast cancer trial

George Mason University researchers are bringing personalized medicine to more breast cancer patients this year as the university teams again with the Side-Out Foundation for the third phase of a groundbreaking trial.

George Mason researchers will be examining why certain breast cancer patients respond well to a specific treatment that may do little for other patients.

"We thank The Side-Out Foundation for supporting our vision to maximize the effectiveness of personalized breast cancer treatments,” said Peggy Agouris, dean of Mason’s College of Science. “The College of Science will continue to take a leadership role in biomedical research of consequence to find effective treatments, prevention methods, and cures for conditions including Lyme disease, Zika virus, and various cancers."

The latest trial focuses on patients with breast cancer tumors that express estrogen receptors, meaning estrogen likely causes the cancer cells to grow, said Mariaelena Pierobon, a researcher with Mason’s Center for Applied Proteomics and Molecular Medicine. Mason researchers will study how the patients’ cancer reacts to FDA-approved treatment that uses a “cdk4/6 inhibitor,” designed to stop estrogen-receptive cancer cell growth.

About 100 patients at 10-12 cancer centers nationwide are expected to participate in the study, slated to begin later this year. All patients will receive the same FDA-approved treatments.

Mason researchers will look for biomarkers to uncover why some patients respond to the treatment and others do not. Oncologists can use that information to find the most effective treatment for their patients, 

“While these drugs are FDA-approved, it doesn’t mean they work for everyone, and indeed there are a significant number of women who get these drugs that receive little clinical benefit,” said Emanuel Petricoin, center co-director. “If we could identify them upfront then not only could they be spared extremely expensive therapies that won’t work for them, but importantly would provide them the opportunity to get other therapies that are also FDA-approved or enter into clinical trials where other exciting therapies are being evaluated.”

The Side-Out Foundation is best known for holding volleyball tournaments to fund breast cancer research. The family of Gloria Dunetz, who died from breast cancer in 2010, started the Side-Out Foundation in 2004. Dunetz’s son, Rick, is a volleyball coach. Side-out is a volleyball term that describes how one team regains the serve or control of the play by scoring a point while its opponent is serving.

The first Side-Out Trial started in 2009 to find new treatments for patients with metastatic breast cancer, a particularly deadly form of cancer with few, if any, treatment options. Traditional chemotherapy had failed these patients. Mason researchers are evaluating the data from the 25 patients in the second trial, Pierobon said.

As a pilot study, the Side-Out Trial was the first of its kind to use a “multi-omic” approach to cancer therapy and use a novel protein activation mapping technology along with the genomic fingerprint of cancer as a way to find the most effective treatment. The study is part of a cutting-edge approach to personalized medicine that looks beyond genomic analysis alone to combine it with what some say is the next frontier in targeted therapy: proteomics.

Mason and the Side-Out Foundation also are partnering to create the Side-Out Foundation Bioinformatics Group. The goal is to create an advanced database for metastatic breast cancer that can be used by oncologists and researchers.

Mason is working with community hospitals to increase treatment accessibility, because roughly 90 percent of breast cancer patients receive care through their community hospitals, Pierobon said.

Pierobon began her medical career as a breast cancer surgeon. Searching for better answers and helping patients and oncologists find the best treatments inspired her to become a researcher.

“Breast cancer is a more complex problem than when I was a surgeon,” Pierobon said.

Pierobon will be discussing how precision medicine is changing cancer therapy at Mason’s free discussion series, Galileo’s Science Café, at 7 p.m. Thursday, Oct. 6, at the Hylton Performing Arts Center. Visit capmm.gmu.edu/galileo-sciencecafe to register.