July 1, 2016:

A new Big Ten Cancer Research Consortium study is testing whether adding palbociclib to tamoxifen might improve response rates in patients with newly diagnosed advanced hormone receptor positive, HER2 negative (HR+/HER2-) breast cancer.

The single-arm phase II study, known as BTCRC-BRE15-016, is currently open for accrual at the University of Illinois Cancer Center, with additional BTCRC member sites expected to open the trial in the coming months.

The study is open to both pre- and post-menopausal women with HR+/HER2- advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced disease. Additional eligibility requirements must be met to enroll in the study.

HR+/HER2- is the most common sub-type of breast cancer. Initial treatment normally involves hormone-based therapies, including aromatase inhibitors, which block the activity of an enzyme called aromatase, which the body uses to make estrogen; selective estrogen receptor modulators (SERMs) such as tamoxifen, which bind to estrogen receptors; and other antiestrogen drugs.

Studies of aromatase inhibitors in combination with palbociclib, an inhibitor of cyclin-dependent kinases (CDKs) 4/6, have shown improved response rates in this patient population. Tamoxifen has shown activity in treating patients with metastatic breast cancer. BTCRC-BRE15-016 will test whether the addition of palbociclib to tamoxifen might lead to improved response rates in advanced disease.

“If this combination proves to be effective, this will offer an option in terms of combination treatment with endocrine therapy and CDK4/6 inhibition for our patients,” said sponsor-investigator Oana Danciu, MD, (pictured) of the University of Illinois at Chicago.

Dr. Danciu notes that while effective treatment options exist for hormone receptor positive breast cancer, it is still unknown why some patients do not respond to combination therapy or develop resistance. She hopes correlative tests done as part of this study will help to answer some of these unknowns.

“By correlative studies, we are looking at blood and other tests from the tumor, trying to identify markers that will signal response to this combination of therapy,” Dr. Danciu said. “And when we see that patients don’t respond to a particular combination, we will try to identify biomarkers that are associated with that.”

Funding support for BTCRC-BRE15-016 is provided through the competitive Advancing Science through Pfizer Investigator Research Exchange (ASPIRE) Breast Cancer Research Awards program.

More information about this clinical trial, including full eligibility criteria, is available at www.clinicaltrials.gov, using trial #02668666.

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 www.bigten.org.