March 3, 2017:

Triple negative breast cancer (TNBC) represents a relatively small proportion — 15 percent — of all breast cancers. Yet a great deal of attention has been given to TNBC in recent years. While targeted therapies have been developed for breast cancers expressing estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2, advances in TNBC have been hampered by a lack of identified targets for the disease. As a result, the only approved treatment for TNBC remains chemotherapy.

Recent discoveries, however, have identified several molecular subtypes of TNBC, and researchers are now developing clinical trials to explore potential ways to treat these subtypes.

A new Big Ten Cancer Research Consortium study, led by Ruth O’Regan, MD (pictured), of the University of Wisconsin Carbone Cancer Center, is taking aim at one of these TNBC molecular subtypes: those that express androgen receptors, including the luminal androgen receptor (LAR) subtype.

The LAR subtype is particularly interesting to Dr. O’Regan because of the success of androgen-targeting therapies in prostate cancer.

“The thought is, could we target androgen receptor in these triple negative breast cancers and potentially result in a treatment that’s going to be effective for patients but also less toxic than the current therapies we have,” she said.

The single arm phase I/II study, known as BTCRC-BRE15-024, will combine bicalutamide, an androgen receptor inhibitor, with ribociclib, a CDK 4/6 inhibitor, in advanced androgen receptor positive (AR+) triple negative breast cancer.

CDK inhibitors have been shown to enhance the efficacy of estrogen-targeting agents. Dr. O’Regan believes the addition of CDK inhibitors might likewise enhance the activity of bicalutamide.

“Our hypothesis is that by using the CDK inhibitor with the androgen receptor inhibitor, we can enhance the efficacy of the androgen receptor inhibitor and hopefully get higher response rates and better disease control than by just targeting the androgen receptor alone,” Dr. O’Regan said.

Patients with androgen receptor positive triple negative breast cancer may be eligible to participate in this study. Additional criteria must also be met.

With the eligible study population constituting a very small proportion of breast cancer patients, Dr. O’Regan notes that collaboration between institutions will be key to the success of the study. “We couldn’t possibly do this study on our own,” she said. “That’s why leveraging these other very strong academic sites through the Big Ten Cancer Research Consortium is pivotal to getting this trial done quickly and efficiently.”

This trial is supported by Novartis Pharmaceuticals Corporation.

About the Big Ten Cancer Research Consortium: The Big Ten Cancer Research Consortium was created in 2013 to transform the conduct of cancer research through collaborative, hypothesis-driven, highly translational oncology trials that leverage the scientific and clinical expertise of Big Ten universities. The goal of the Big Ten Cancer Research Consortium is to create a unique team-research culture to drive science rapidly from ideas to new approaches to cancer treatment. Within this innovative environment, today’s research leaders collaborate with and mentor the research leaders of tomorrow with the unified goal of improving the lives of all patients with cancer.

About the Big Ten Conference: The Big Ten Conference is an association of world-class universities whose member institutions share a common mission of research, graduate, professional and undergraduate teaching and public service. Founded in 1896, the Big Ten has sustained a comprehensive set of shared practices and policies that enforce the priority of academics in the lives of students competing in intercollegiate athletics and emphasize the values of integrity, fairness and competitiveness. The broad-based programs of the 14 Big Ten institutions will provide over $200 million in direct financial support to almost 9,500 students for more than 11,000 participation opportunities on 350 teams in 42 different sports. The Big Ten sponsors 28 official conference sports, 14 for men and 14 for women, including the addition of men’s ice hockey and men’s and women’s lacrosse since 2013. For more information, visit