Landmark cancer clinical trial underway

The widely anticipated I-SPY 2 clinical trial was launched today by Biomarkers Consortium. This trial will involve as many as 800 patients in 20 US cancer centers, and is open to women with newly diagnosed locally advanced breast cancer. Many expect this trial to forever change the way new cancer drugs and therapies are tested.

On its face, the trial seems no different than any other, since it will test whether adding investigational drugs to standard chemotherapy is better than standard chemotherapy alone prior to undergoing surgery.

The difference is that the trial will investigate as many as a dozen different drugs from different manufacturers at one time, as opposed to a single agent. As results come in, doctors will have the flexibility to make changes to patient recruitment and to drop the ineffective drugs from the trial when it's clear they're not working.

In short, doctors will be able to personalize the therapies to individual patients and their tumors as the trial goes along, using biomarkers including genes and proteins to tailor the treatment to fit the tumor. This flexibility has the potential to save billions of dollars, and more importantly, to get effective therapies to market significantly sooner than ever before.

The trial's name, I SPY 2, is an acronym for Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2.

Read more about it at http://ispy2.org.