In April 2010, the University of Minnesota’s Masonic Cancer Center joined 19 leading research institutions from across the United States in launching the ISPY 2 clinical trial – a large-scale effort designed to establish a new way of developing and testing new pharmaceutical therapies in patients battling breast cancer.
The ISPY 2 trial will use patterns of expression of genetic material and proteins within a tumor – signatures known as biomarkers – to build tumor profiles and assess which ones are most likely to respond to a new breast cancer therapy. By evaluating drugs in such a way, researchers hope to identify and develop promising drugs in real time, expediting the drug development process. It may surprise some patients to learn that it can take 12-15 years to bring a drug to the market; most drugs commonly used today were designed in the 1990’s or earlier.
Changing the drug development timeline is only one benefit of the ISPY 2 effort, said University of Minnesota Physician Tufia Haddad, M.D., a breast cancer specialist within the Masonic Cancer Center and the principal investigator for the ISPY 2 trial, Utilizing a patient’s tumor profile and adding a novel targeted therapy to her standard treatment regimen also have the potential to dramatically improve how physicians fight cancer.
“Right now, the paradigm is to test a new drug in patients with incurable disease – patients for which there are no other established treatments available,” Haddad said. “Why ISPY 2 is potentially so groundbreaking is that in a single trial we’re testing multiple new drugs at a time with standard chemotherapy in patients with early stage, potentially curable breast cancer. The goals are to increase the patient cure rates and establish tumor profiles that predict tumor responsiveness to these new drugs. These types of tumor profiles could redefine the standard of care going forward.”
The ISPY 2 trial is a logical progression from the original ISPY trial which determined if there are molecular markers in breast cancer tissue or changes in a tumor that can predict its response to standard chemotherapy. Within the ISPY 2 trial, a patient’s tumor profile is constructed using not just biomarkers present in the tumor tissue, but also through MRIs and other forms of diagnostic imaging. Such comprehensive profiles will allow researchers to determine – upon diagnosis – which treatment approaches stand the best chances of long term cure.
Haddad believes the ISPY 2 trial will help doctors become more intelligent about choosing the right treatment approach.
“A number of treatment options exist today,” said Haddad. “If a woman comes through our door, we can say what works for most women with their type of breast cancer, but we can’t promise that it will work in every woman. In the future, we hope to be able to say that based on a patient’s unique tumor profile, that one treatment option stands a better chance of working than another. By selecting correctly up front we can enhance the possibility for a durable cure.”
For more information about the ISPY 2 trial, or the original ISPY trial, visit the Clinical and Translational Science Institute web site or call (612) 625-CTSI (2874) or visit the Masonic Cancer Institute’s clinical trials web site.
--- Justin Paquette