Breast Cancer Study Aims to Speed Drugs, Cooperation

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Researchers launched a unique collaboration aimed at getting cancer drugs to the market more quickly on Wednesday — one in which three companies will cooperate with government and non-profit groups to test five experimental breast cancer drugs.

The study, called Investigation of Serial Studies to Predict your Therapeutic Response with Imaging and Molecular Analysis, or I-SPY2, will aim to use DNA to match the best drug to each individual patient, and to more quickly toss out approaches that do not work or that are too toxic.

The launch of the $26 million, five-year experiment will be announced at 9 a.m. EDT (1300 GMT) in Washington, and details can be seen here

Unusually, the companies agreed to share information on using genes to predict how well a patient will respond as part of the Biomarkers Consortium, which includes the U.S. Food and Drug Administration and the National Institutes of Health.

"I think it is the theme for the future of research," Anna Barker, deputy director of the National Cancer Institute, said in a telephone interview.

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

The trial will match patients to one of five experimental drugs:

— ABT-888 or veliparib, being developed by Abbott Laboratories. The pill is a PARP inhibitor, which blocks a cell repair enzyme used by cancer cells.

— AMG 655 or conatumumab, a targeted drug being developed by Amgen. It is an APO/TRAIL inhibitor that causes cancer cells to self-destruct.

— Amgen's AMG 386, an angiogenesis inhibitor that stops tumors from growing blood vessels to nourish themselves.

— CP-751,871 or figitumumab, being developed by Pfizer Inc. to target the insulin growth factor receptor or IGFR.

— Pfizer's HKI-272 or neratinib, another targeted therapy called a Pan ErbB inhibitor that targets several related receptors used by cancer cells.


"It is the best combination I have seen of state-of-the art biomarkers and state-of-the-art drugs that enable us to put drugs into patients and start evaluating them on a faster basis," Barker said.

"It'll speed up the whole process."

Patients at 20 cancer centers will be tested right after they get tiny samples of tissue taken called biopsies. Before they ever get surgery, they will be treated with one of the drugs to see if this helps prevent tumor spread.

Up to 12 different cancer drugs will be tested. Unusually, the group has FDA approval to drop and add drugs throughout the course of the trial without having to stop the trial to write a whole new protocol.

Safeway Inc. is paying for a large part of experiment. Johnson & Johnson, Roche AG subsidiary Genentech and Eli Lilly and Co. will also provide funding.

"This approach could apply to other diseases and other cancer," said Barker.

UCSF Chancellor Dr. Sue Desmond-Hellmann said the approach could save the U.S. healthcare system money.

"It has the opportunity to make clinical trials more efficient so we will spend less to develop new remedies," Desmond-Hellmann, a former drug company executive, said in a telephone interview.

"I predict that companies will be watching this."