A new clinical trial will try to find out whether using Herceptin (chemical name: trastuzumab) alone, Tykerb (chemical name: lapatinib) alone, or both medicines together is better for women diagnosed with stage I or stage II HER2-positive breast cancer. Women who have and haven't already received chemotherapy are eligible to participate in this study. Women in the study will be treated for a year, so it will be a while before the results are available.
Herceptin and Tykerb both are targeted therapies used to treat HER2-positive breast cancers. HER2-positive cancers have extra HER2 genes and make too many HER2 protein receptors (also called HER2/neu proteins).
Herceptin is approved to treat women with both early and advanced HER2-positive breast cancer. Tykerb is approved to be given in combination with Xeloda (chemical name: capecitabine) to treat advanced, HER2-positive breast cancer that has stopped responding to anthracyclines, taxanes, and Herceptin.
Even though Herceptin and Tykerb both target HER2-positive breast cancers, each medicine works in a different way. Herceptin blocks the HER2 protein on the cancer cell's surface. Tykerb blocks the HER2 protein inside the cell. Because of these differences, researchers believe it's possible that either Herceptin or Tykerb might work better than the other, or that combining the two medicines might offer more benefits than either one alone. Clinical trials are the best way to scientifically compare different treatments. The results of clinical trials help doctors decide on the best treatment plan for each woman's unique situation.
If you've been diagnosed with HER2-positive breast cancer, talk to your doctor about your treatment options and the two treatments being studied in this clinical trial. Your doctor can help you decide on the treatment plan that is best for you. Your doctor also can give you some guidance on whether or not participating in this clinical trial is practical and makes sense for you.
Visit the Breastcancer.org section on Clinical Trials for more information and a link to the NCI Clinical Trial listing.
LONDON (Reuters) - GlaxoSmithKline Plc's new breast cancer drug Tykerb is to go head-to-head with Genentech Inc's blockbuster Herceptin to see whether one is better or if patients should get both.
The U.S. National Cancer Institute said 8,000 participants in 50 countries would be given either Herceptin or Tykerb, or Herceptin followed by Tykerb, or the two treatments in combination.
Glaxo is providing financial support for the trial.
Both Herceptin and Tykerb, known generically as trastuzumab and lapatinib, have been approved for treating HER2-positive breast cancer, an aggressive form of the disease found in 20 to 30 percent of patients with a particular gene mutation.
The new study, expected to end in 2011, will provide oncologists with the first direct comparison of the drugs in the earliest, most treatable stages of cancer.
"It may be that using two treatments that work in different ways against HER2-positive breast cancer offers a complementary strategy that is more powerful than either drug alone," Dr Edith Perez of the Mayo Clinic in Jacksonville, Florida, who is leading the study, said in a statement.
HER2-positive breast cancer is caused by an excess of HER2 genes or by over-production of its protein, the HER2 cell surface receptor.
Herceptin consists of large antibodies that latch on to the portion of the HER2 protein on the outer surface of the cancer cell, while Tykerb acts by entering a cancer cell and binding to part of the protein lying beneath the cell surface.
The new study has two different designs depending on whether patients with stage I or stage II breast cancer have already been treated with chemotherapy. It will therefore compare four different regimens of targeted therapy administered over a 52-week period.
Herceptin is sold outside the United States by Genentech's partner Roche Holding AG.
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