Dr Nanda on the Importance of Clinical Trials in Breast Cancer

“How we move the field forward, improve therapies, and improve outcomes for patients with breast cancer is all done through clinical trials.”

Rita Nanda, MD, the director of the Breast Oncology Programs and an associate professor of medicine at UChicago Medicine, discussed the role of clinical trials in the breast cancer treatment landscape.

Clinical trials are an essential part of improving the therapeutic landscape for patients with breast cancer, Nanda began, adding that evaluating both novel agents and established therapies in new settings is critical for moving the field of breast cancer research forward.

Nanda serves as principal investigator for the Translational Breast Cancer Research Consortium as well as the I-SPY 2 Clinical Trial Network. The Translational Breast Cancer Research Consortium is a collaborative group founded in 2005 that is composed of 18 clinical sites, 5 core working groups, 4 other groups focused on specific breast cancer phenotypes, 4 interest groups, a patient recruitment task force, a patient advocate working groups, a study coordinator working group, a contracts/administrators working group, and a central office. The consortium works together to enable clinical trial development with an emphasis on cross-institutional collaboration.

I-SPY 2 (NCT01042379) is an adaptive phase 2 clinical trial design program that tests novel agents in the neoadjuvant setting for the treatment of patients with high-risk breast cancer. The study examines agents in combination with standard chemotherapy in the neoadjuvant setting. Clinical biomarkers are used to classify patients with breast cancer into 10 subtypes, and Bayesian methods of adaptive randomization are then employed to allow individualized patient assignment to therapy arms to maximize treatment effects. Pathological complete response serves as the study’s primary end point. Of note, the study allows for agents to be dropped if they display a low probability of improved efficacy with any biomarker signature, and new agents can enter the study as evaluation ends for those already under examination.