Breast cancer drugs get faster screening

Experimental breast cancer drugs will be tested under a new DNA matching approach that aims to find out which treatments work best and more quicklyfor certain patients.

The five-year, $26-million-US study is different from conventional clinical trials because it will screen severaldrugs at once and identify which treatments work best for specific types of patients with high-risk, fast-growing breast cancers.

Drugs that are too toxic or don't work early in the trial will be eliminated faster than usual.

'We have set up a system where everyone can learn faster and, together, we can dramatically reduce the amount of time and the cost to bring those drugs to market that can make a difference in whether women live or die.' Dr. Laura Esserman

The project, which launched Wednesday, is called the "Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis," or I-SPY2.

"I-SPY 2 will provide a path to personalized medicine," said Dr. Laura Esserman, a breast cancer surgeon and researcher at the University of California in San Francisco who will help lead the clinical trials.

"We have set up a system where everyone can learn faster and, together, we can dramatically reduce the amount of time and the cost to bring those drugs to market that can make a difference in whether women live or die," she added in a statement.

The Biomarkers Consortium involves a unique collaboration between scientists at the National Cancer Institute, the U.S. Food and Drug Administration, the National Institutes of Health and major pharmaceutical companies.

Unlike in previous trials, the companies have all agreed to share information on how experimental biomarkers patterns of gene activity and protein production may predict which drugs work best in patients, based on the molecular profiles of their tumours.

The trial is designed to assess results quickly, which should improve the efficiency of the huge and costly Phase III trials that are needed before regulators can approve a drug for use. Currently, it takes more than $1 billion US, 12 to 15 years and thousands of patient volunteers to get a single drug to market, the consortium said.

5 drugs to be tested

Participating patients at 20 cancer centres in the U.S. will be tested before they give samples of tissue for biopsy.

Before surgery, they will be treated with the most suitable current treatment and one of the experimental drugs to see if it helps prevent tumour spread, with magnetic resonance imaging as the guide of spread.

So far, researchers expect to test these five experimental drugs described the National Cancer Institute:

• ABT-888 or veliparib, being developed by Abbott Laboratories. The pill is a "PARP inhibitor," which blocks a DNA repair enzyme used by cancer cells.
• AMG 655 or conatumumab, a targeted drug being developed by Amgen. The drug mimics the activity of a protein called APO/TRAIL that causes cancer cells to undergo apoptosis or programmed cell death.
• Amgen's AMG 386, an angiogenesis inhibitor that stops malignant tumors from growing blood vessels to gain oxygen and nutrients.
• CP-751,871 or figitumumab, being developed by Pfizer Inc. target the insulin growth factor receptor or IGFR that tumour cells need to survive.
• Pfizer's HKI-272 or neratinib, which targets several receptors used by cancer cells.

To maximize public health benefit, the non-profit Foundation For theNational Institutes of Healthwill manage data and intellectual property arising from the trial.

Safeway Inc.'s charitable foundation is a major seed funder and Johnson & Johnson,Genentech and Eli Lilly and Cowill also provide funding.

TheFoundation For the NIHaims toraise the remaining funds from pharmaceutical and other companies, non-profit cancer organizations,philanthropic foundations and individuals.