Online study of Avastin breast cancer patients

South San Francisco's Genentech has teamed up with personal genetics company 23andMe for a new kind of study - one that doesn't require patients to find a clinical trial center or make frequent visits to a doctor's office.

The Bay Area companies are initiating an online effort to recruit 1,000 patients with metastatic breast cancer who have taken Genentech's Avastin, a drug that had its approval for breast cancer revoked last year over safety and efficacy concerns.

Genentech officials hope to find genetic markers in those patients that could identify who might respond better to the drug than others. They say the study is not necessarily designed to get the drug back on the market for breast cancer, but to figure out if Avastin helps certain types of breast cancer patients. Such research could ultimately lead to its reapproval.

"We've always said our commitment to the community of breast cancer is there," said Dr. Philippe Bishop, Genentech vice president and head of clinical development for Avastin.

Critics say the online study appears to be biased toward women who have done well on Avastin, but its sponsors say they're simply trying to find common factors in a large group of patients that could be tested in more traditional clinical trials.

"This is probably the first study leveraging the Internet to find individuals," said Anne Wojcicki, chief executive officer of 23andMe, which is based in Mountain View. "Part of what we're trying to do is empower individuals to actually have a voice in research."
Approval revoked

The U.S. Food and Drug Administration revoked its approval of Avastin for breast cancer after studies showed the drug caused life-threatening side effects such as bleeding and heart failure. Studies also found it failed to help patients with metastatic breast cancer live longer.

Doctors can still provide the drug "off label" for breast cancer, but insurers are more likely to refuse to pay for it. Meanwhile, Avastin continues to be available for certain types of colon, lung, kidney and brain cancers.

The decision to pull Avastin's approval was devastating for people like Christi Turnage, who testified before an FDA advisory panel last year and gathered nearly 13,000 signatures in support of its use for breast cancer.

Genentech officials credited Turnage with helping to inspire the study because immediately after the panel's decision, she offered to donate tissue samples or do whatever she could to help the company figure out why the drug appears to benefit some patients but not others.

"I have nothing else I can take," said Turnage, 50, of Madison, Miss., who has what is known as the "triple negative" form of breast cancer. That means her type of tumors lack the three receptors - molecules that bind to specific hormones - known to fuel breast cancer. In turn, all the available drugs that target the receptors do not work.