FDA Approves Test That Spots Aggressive Breast Cancer (HealthDay)

TUESDAY, June 14 (HealthDay News) -- A new genetic test that helps determine if breast cancer patients are good candidates for treatment with the drug Herceptin was approved Tuesday by the U.S. Food and Drug Administration.

About 20 percent of breast cancers are HER2-positive, and respond well to Herceptin (trastuzumab).

The new Inform Dual ISH test reveals the number of copies of the HER2 gene in tumor tissue.

"When used with other clinical information and laboratory tests, this test can provide health-care professionals with additional insight on treatment decisions for patients with breast cancer," Alberto Gutierrez, director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA's Center for Devices and Radiological Health, said in an agency news release.

The FDA's approval of the test was based on a U.S. study that included tumor samples from 510 breast cancer patients. The study found that the test was effective in confirming a higher than normal number of copies of the HER2 gene in 96 percent of the HER2-positive tumor samples.

The test was also effective in excluding the possibility that more than the normal number of copies of the HER2 gene were present in 92.3 percent of HER2-negative tumor samples, according to the FDA.

Dr. Stephanie Bernik, chief of surgical oncology at Lenox Hill Hospital in New York City, said the new test will help "in acquiring the data about a woman's cancer more quickly and efficiently. This will help speed the process of formulating a treatment plan during a time when a woman is searching for answers regarding her future.

"The faster a treatment plan is formulated, the easier it is for a woman to deal with her diagnosis. When faced with too many unknowns, the diagnosis of breast cancer can be overwhelming. Because this test can be performed in a standard lab, the information regarding HER2 status will be known quickly, and a woman will know if her treatment will be over within a few months, or might go on for a full year," Bernick said.

Dr. Freya Schnabel, director of Breast Surgery at NYU Langone Medical Center, said: HER2 testing is an "important part of the assessment of breast cancer tissue, because it tells us important information about the biology of the tumor and also helps identify the subset of patients who would benefit from treatment with Herceptin. At this point, testing for HER2/neu frequently involves two levels of testing and there is sometimes lack of agreement between test results, making a patient's status unclear."

The new test is made by Tucson, Ariz.-based Ventana Medical Systems.

More information

The American Cancer Society has more about breast cancer.

New Test Helps Evaluate Breast Cancer Patients for Herceptin Use (HealthDay)

TUESDAY, June 14 (HealthDay News) -- A genetic test to help doctors evaluate whether women with breast cancer are candidates for treatment with the drug Herceptin (trastuzumab) has been approved by the U.S. Food and Drug Administration.

The Inform Dual ISH test measures whether there are excessive copies of the HER2 gene in breast tumor tissue. HER2-positive breast cancer is a fast-growing, aggressive form of the disease, making up about 20 percent of all breast cancer cases, the FDA said in a news release. Women with an above-normal number of copies of the HER2 gene are candidates for Herceptin therapy.

Clinical studies involving 510 women with breast cancer showed the new test was 96 percent accurate in identifying HER2-positive tumor samples, the agency said. The test correctly identified HER2-negative tumors in 92.3 percent of cases.

Breast cancer is the second-leading cause of cancer deaths among women, the FDA said, citing some 207,090 cases diagnosed in the United States last year, and about 39,840 deaths from the disease.

The new test is produced by Ventana Medical Systems, based in Tucson, Ariz.

More information

The U.S. National Institutes of Health has more about breast cancer.

Drug Halts Growth of Stubborn Breast Cancer Cells (LiveScience.com)

The tricky breast cancer cells that scientists say survive through chemotherapy treatments and sprout new cancer growths elsewhere in the body may soon meet their match.

A new study shows that these cells, called breast cancer stem cells, rely on a certain molecular pathway to survive, and that when this pathway is turned off by a drug, the cells stop dividing.

Not all types of breast cancer have these stem cells, said study researcher Dr. Kornelia Polyak, an associate professor of medicine at Harvard Medical School.

But about 50 percent of the hard-to-treat "triple-negative" breast cancer patients do have them, Polyak said. Triple-negative breast cancers get their name from the fact that they lack three hormone receptors found in other breast cancers.

There are no targeted therapies (which are treatments designed to selectively kill cancer cells) currently approved to treat triple-negative breast cancers, so chemotherapy (which affects many cells in the body) remains the only option, and it does not work for 80 percent of patients, Polyak said.

The new study reveals a way that a targeted therapy might work. The researchers found 15 genes that had higher levels of activity in breast cancer stem cells than in other breast cancer cells. They then found that all these genes played a role in a single pathway in the cells — called the Jak2/Stat3 pathway.

The high level of activity of the genes led the researchers to discover that not only is this pathway activated in breast cancer stem cells, but also that the stem cells need the pathway to be turned on in order to divide.

"When it's off, the tumors stopped growing," and some of the cancer stem cells died, Polyak said. Other cells, which do not have this pathway activated, can survive even if this pathway is blocked. So, the researchers concluded, blocking this pathway with a drug would be a good strategy for selectively halting the growth of these cells.

"Cancer stem cells" are not the same as other stem cells, Polyak noted, they are simply cells within a tumor that seem to give rise to new tumors more easily than other cancer cells do. Because of the many genetic changes that constantly occur in cancer cells, any given cancer cell may become a "cancer stem cell," or can revert back. 

"We're very excited about the findings," Polyak said, because the pathway is not only crucial to the growth of the cancer stem cells, it is also involved with the growth of blood vessels that feed tumors and with the production of inflammation around tumors. By blocking this pathway, she said, "we can hit tumor multiple different ways."

The study was conducted on human breast cancer cells growing in lab dishes and injected into mice to form tumors, so the findings need to be validated in clinical trials done with breast cancer patients.

But drugs that block this pathway, which can be taken orally, are already being tested in several types of blood cancer, so much of initial safety testing has already been done, Polyak said. In fact, a clinical trial is set to begin in patients with triple-negative breast cancer at the Dana-Farber Cancer Institute in Boston later this year, she said.  

Triple-negative breast cancers make up about 15 to 20 percent of breast cancers and tend to occur in younger women, those with BRCA1 gene mutations, and black women.

Pass it on:  Scientists have identified a way to selectively kill breast cancer stem cells.

Follow MyHealthNewsDaily Managing Editor KarenRowan on Twitter @karenjrowan

• 3 Lifestyle Choices Lower Breast Cancer Risk, Regardless of Family History
• The 10 Deadliest Cancers and Why There's No Cure
• Breast Cancer: Symptoms, Treatment & Prevention