US launches new breast cancer treatment study

(Piotr Marcinski)

Researchers launched a clinical study Wednesday to test new treatments for aggressive breast cancer in a rare alliance between the US government and five major drug companies.

The new drugs may help boost survival rates for women diagnosed with this type of breast cancer which does not respond to the standard treatments, the Biomarkers Consortium said in a statement.

The trial, dubbed the I-SPY 2, will use genetic markers from the tumors of individual patients in a bid to screen the results to find the most promising treatments and determine which are the most effective.

"I-SPY 2 promises to leverage convergence of progress on a number of research fronts to speed the evaluation of promising new breast cancer drugs using molecular cancer biomarkers to identify those agents that are effective in specific subpopulations of breast cancer patients," said Anna Barker, deputy director of the National Cancer Institute.

"This will allow us to finally design advanced, smaller and less expensive Phase III trials that test the right drugs in the right patients," she added.

Phase III is the last testing stage before drugs are given final approval to be put on the market.

The consortium, which includes the US Food and Drug Administration as well as nearly 20 cancer research centers across the country, hopes to cut both the costs and time it takes to develop new drugs for the public.

At the moment it takes more than one billion dollars, 12 to 15 years of research and thousands of patient volunteers to get a single drug to market, the group said in its statement.

Five new experimental anti-cancer treatments which are being developed by three major pharmaceutical companies will be tested as part of the study, which is expected to cost 26 million dollars over five years.

The I-SPY 2 trial will focus on treatments in which patients receive chemotherapy to reduce tumor size before surgery.

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

"The collaborative power behind this trial is truly transformational for breast cancer patients and for cancer research as a whole," she added.

"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."

Among the treatments being studied are drugs developed by Abbott Laboratories, Amgen and Pfizer.