Adaptive trial to aid cancer drug choice

In a smart makeover to clinical trials, cancer researchers are turning to biomarkers in hopes of reinventing the trial process by providing better direction in drug-to-patient matchups. The adaptive trial design promises cost and time savings.

I-SPY2, an effort being led by the Biomarker Consortium, will use MRI bio-imaging as the basis of an adaptive trial for breast cancer treatments. The goal is to quickly and efficiently test the most promising drugs in development for women with higher risk, rapidly growing breast cancers.

Researchers will screen patient tumor biomarkers and attempt to match them biologically with the drug candidates, identifying which treatments are most effective in specific types of cancer patients. The trial is adaptive in the sense that researchers will use early data from one set of subjects to guide their treatment decisions for patients later in the trial.

Researchers will use Agendia's MammaPrint breast cancer recurrence test and TargetPrint Her2 risk scores, as well as estrogen receptor and progesterone receptor status information and MRI to help determine eligibility for the trial. The program launch was announced last Wednesday and currently involves five drug candidates from Abbott Labs, Amgen and Pfizer. Plans call for the eventual use of as many as 12 candidates.

The goal of the five-year Phase II trial is to gain a greater than 85 percent success rate in Phase III trials by focusing on patients who benefit from each particular treatment. Researchers anticipate that the Phase III effort should require far fewer subjects.

The I-SPY II trial follows the I-SPY I trial, which began in 2003 and was aimed at predicting how women would respond to standard chemotherapy using multiple MRI scans and biomarkers.

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